POZ July/August 2023

Josh Kruger

IMPORTANT FACTS FOR BIKTARVY®

This is only a brief summary of important information about BIKTARVY® and does not replace talking to your healthcare provider about your condition and your treatment.

MOST IMPORTANT INFORMATION ABOUT BIKTARVY

BIKTARVY may cause serious side e ects, including:

` Worsening of hepatitis B (HBV) infection. Your healthcare provider will test you for HBV. If you have both HIV-1 and HBV, your HBV may suddenly get worse if you stop taking BIKTARVY. Do not stop taking BIKTARVY without fi rst talking to your healthcare provider, as they will need to check your health regularly for several months, and may give you HBV medicine.

ABOUT BIKTARVY

BIKTARVY is a complete, 1-pill, once-a-day prescription medicine used to treat HIV-1 in adults and children who weigh at least 55 pounds. It can either be used in people who have never taken HIV-1 medicines before, or people who are replacing their current HIV-1 medicines and whose healthcare provider determines they meet certain requirements.

BIKTARVY does not cure HIV-1 or AIDS. HIV-1 is the virus that causes AIDS.

Do NOT take BIKTARVY if you also take a medicine that contains:

` dofetilide

` rifampin

` any other medicines to treat HIV-1

BEFORE TAKING BIKTARVY

Tell your healthcare provider if you:

` Have or have had any kidney or liver problems, including hepatitis infection.

` Have any other health problems.

` Are pregnant or plan to become pregnant. It is not known if BIKTARVY can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking BIKTARVY.

` Are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk.

Tell your healthcare provider about all the medicines you take:

` Keep a list that includes all prescription and over-thecounter medicines, antacids, laxatives, vitamins, and herbal supplements, and show it to your healthcare provider and pharmacist.

` BIKTARVY and other medicines may a ect each other. Ask your healthcare provider and pharmacist about medicines that interact with BIKTARVY, and ask if it is safe to take BIKTARVY with all your other medicines.

POSSIBLE SIDE EFFECTS OF BIKTARVY

BIKTARVY may cause serious side e ects, including:

` Those in the “Most Important Information About BIKTARVY” section.

` Changes in your immune system. Your immune system may get stronger and begin to fight infections that may have been hidden in your body. Tell your healthcare provider if you have any new symptoms after you start taking BIKTARVY.

` Kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys. If you develop new or worse kidney problems, they may tell you to stop taking BIKTARVY.

` Too much lactic acid in your blood (lactic acidosis), which is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat.

` Severe liver problems , which in rare cases can lead to death. Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark “tea-colored” urine, light-colored stools, loss of appetite for several days or longer, nausea, or stomach-area pain.

` The most common side e ects of BIKTARVY in clinical studies were diarrhea (6%), nausea (6%), and headache (5%).

These are not all the possible side e ects of BIKTARVY. Tell your healthcare provider right away if you have any new symptoms while taking BIKTARVY. You are encouraged to report negative side e ects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088. Your healthcare provider will need to do tests to monitor your health before and during treatment with BIKTARVY.

HOW TO TAKE BIKTARVY

Take BIKTARVY 1 time each day with or without food.

GET MORE INFORMATION

` This is only a brief summary of important information about BIKTARVY. Talk to your healthcare provider or pharmacist to learn more.

` Go to BIKTARVY.com or call 1-800-GILEAD-5.

` If you need help paying for your medicine, visit BIKTARVY.com for program information.

BIKTARVY, the BIKTARVY Logo, GILEAD, the GILEAD Logo, and KEEP BEING YOU are trademarks of Gilead Sciences, Inc., or its related companies. © 2023 Gilead Sciences, Inc. All rights reserved. US-BVYC-0250 04/23

#1 PRESCRIBED HIV TREATMENT*

No matter where life takes you,

ELIAS SWITCHED TO BIKTARVY

Because HIV doesn’t change who you are.

BIKTARVY® is a complete, 1-pill, once-a-day prescription medicine used to treat HIV-1 in certain adults. BIKTARVY does not cure HIV-1 or AIDS.

Ask your healthcare provider if BIKTARVY is right for you.

Person featured takes BIKTARVY and is compensated by Gilead.

Please see Important Facts about BIKTARVY, including important warnings, on the previous page and at BIKTARVY.com.

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20 I STOPPED TAKING MY HIV PILLS Long-acting injectables made Josh Kruger rethink HIV treatment, activism and the size of his butt.

BY JOSH KRUGER

24 GOING LONG Long-acting therapies are the future of HIV treatment and prevention.

3 FROM THE EDITOR

Hit Me With Your Best Shot

4 POZ Q & A

Marc Franke, aka the Düsseldorf Patient, is part of an exclusive circle of people cured of HIV after a stem cell transplant.

6 POZ PLANET

Studying why HIV rates among women in the South are higher than in other regions

• FDA eases blood donation rules, but people who use meds to prevent or treat HIV can’t donate

• training HIV behavioral scientists • tallying U.S. mpox deaths

• Russian prisoners living with HIV join the war against Ukraine in order to access treatment

• Everyday: milestones in the HIV epidemic

11 VOICES

Positive Women’s Network–USA asks: Why does the mifepristone decision matter for the HIV community?

BY LIZ HIGHLEYMAN

12 NUTRITION & FITNESS

Carrot & orange soup • try green exercise

14 RESEARCH NOTES

Daily oral PrEP to prevent HIV is effective for cisgender women • a clinical trial of a weekly oral HIV treatment regimen is back on track • a combination approach aims to eliminate HIV using two types of CRISPR

• people living with HIV are more likely to experience sleep disorders

16 CARE & TREATMENT

Statin reduces cardiovascular risk for people living with HIV

• U.S. meets perinatal HIV elimination goals

• do natural HIV controllers need treatment?

• HIV among transgender men

32 HEROES

HIV researcher Chloe Orkin was the lead investigator for the First Long-Acting Injectable Regimen study.

Josh Kruger made the switch to long-acting injectables.

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Hit Me With Your Best Shot

IDO NOT

LIKE NEEDLES.

I never have, and I never will. After more than 30 years of living with HIV, I still get anxious every time I get my blood drawn.

That said, I do understand just how important they are to all of us seeking a healthier life. They not only draw blood to monitor our health, they also deliver vaccines to prevent diseases and medications to treat them. The benefits far outweigh the momentary pain. At least, that’s what I keep telling myself.

So when I first started hearing about long-acting injectables for HIV treatment, I was both elated and apprehensive. I admit the idea of not having to take pills anymore is intriguing. However, I have had the good fortune of being undetectable taking one pill once per day for decades. Do I really want to take a chance with injectables?

I am far from alone these days in thinking about making the switch. Our cover subject, Josh Kruger, wrestled with these questions, carefully weighing the pros and cons. Ultimately, he decided to stop taking his pills. Go to page 20 to read how long-acting injectables made Josh rethink HIV treatment, activism and the size of his butt.

Long-acting therapies are the future of HIV treatment and prevention. Injectable antiretrovirals taken less often than current options and longer-acting oral drugs are in the pipeline. Until there is a widely applicable cure, I’m glad that we continue to have new choices. Go to page 24 to learn more.

I mentioned “widely applicable” because we have already witnessed an HIV cure. The late Timothy Ray Brown was the first person to be cured. To treat his leukemia, he received a stem cell transplant, which also had a mutation that cured his HIV. Timothy died years later from a recurrence of his cancer.

To ensure that this method wasn’t just a lucky break, researchers repeated the pro-

cedure on others living with the virus who were also fighting leukemia. At least five people have been cured of HIV by this method. Marc Franke is one of them. Go to page 4 to read more about his journey.

Knowing that there are people who no longer have HIV is a comforting thought. A cure is indeed scientifically possible. What we all need, however, is a widely applicable one. The risks and costs involved in using stem cell transplants with the appropriate mutation are just too prohibitive to make this method available to everyone who needs it.

In the meantime, continuing to develop HIV treatment and prevention methods that make our lives easier remains a priority. Researchers are hard at work on them. Among them is Chloe Orkin. She was the lead investigator for the First Long-Acting Injectable Regimen study. Go to page 32 for more on how Chloe prioritizes equity and uplifts the HIV research community as a result.

This special edition dedicated to HIV treatment also includes the 2023 HIV Drug Chart. Go to the back of the issue to read more.

ORIOL R. GUTIERREZ JR. EDITOR-IN-CHIEF editor-in-chief@poz.com

Want to read more from Oriol? Follow him on Twitter @oriolgutierrez and check out blogs.poz.com/oriol.

BY LIZ HIGHLEYMAN

COMING OUT AS CURED

Marc Franke is part of an exclusive circle of people cured of HIV after a stem cell transplant.

MARC FRANKE, 54, REMAINS FREE OF HIV A DECADE AFTER receiving a stem cell transplant to treat leukemia from a donor with a rare mutation that makes immune cells resistant to the virus. Dubbed the Düsseldorf Patient, Franke lives in a nearby small city in Germany with his husband, Ingo, and their dog, Motte.

Franke is either the second person to be cured using this procedure, after Timothy Ray Brown (the Berlin Patient), if counting from the date of his transplant in February 2013, or the third, after Brown and Adam Castillejo (the London Patient), if counting from when he stopped antiretroviral therapy in late 2018. A Southern California man (the City of Hope Patient) and a woman treated in New York City have since joined the exclusive club.

But Franke’s doctors—Björn Jensen, MD, and Guido Kobbe, MD, at Düsseldorf University Hospital—were cautious about declaring a cure, and he has not gotten the same extensive media coverage as the other four cases. Franke decided to go public this year when a report about his case was published in Nature Medicine. After POZ covered the news in February, he offered to tell us more.

How did you find a donor with the CCR5-delta32 mutation, which blocks HIV from entering immune cells?

I saw a documentary about Timothy on TV at the end of 2012. I don’t remember if I asked my doctors about searching for such a donor or if they mentioned it. They found five matching donors, and one had the gene defect. Only 1% of the Caucasian

population has two copies of the mutation, from the father and mother. I was so happy because I knew it was a little needle in a big haystack. It was like winning the lottery.

What was it like being treated for leukemia and undergoing the transplant? No one who hasn’t gone through it can imagine how hard it is. I had my first chemotherapy in 2011, and they thought they could cure my leukemia. I met Ingo before the leukemia diagnosis. I was chatting on [the dating app] Gay Romeo at the hospital because I had time to kill. He didn’t care if I had HIV. He visited me the next day, then he came every day. I went through chemo so well because I wanted to have my normal life back and get to know Ingo better. The power of love guided me through all of this.

But the chemo didn’t cure me, and I got the transplant on Valentine’s Day in 2013. My donor was female, so it was

Marc Franke, the Düsseldorf Patient, with his dog, Motte

easy to tell that it worked. Special chemo and T cells from the donor got rid of all my male immune cells. It was a very risky year after the transplant. So many things went wrong. I got hepatitis and had to take cortisol to save my liver. Because of the cortisol, I got diabetes and had to inject insulin. Then my hip broke, so I needed a new hip. I had problems with my brain, a strange encephalitis, and I had to go to intensive care for several weeks. And I have graftversus-host disease [when the donor cells attack the recipient’s body], which gives me dry eyes. If you see me now, you think, Oh, everything is fine, but everything is not fine.

You had the opportunity to meet your stem cell donor. What was that like?

In Germany, it’s not a problem to meet your donor, but you have to wait a year to get in contact. My donor, Anja, contacted me at the beginning of 2014, but at that time, my constitution was not so good, and I was not in the mood to answer, so I answered her half a year later. We chatted on the telephone for hours, and I told her she was very, very special for me. They had told her that her body has a special kind of immunity, but they didn’t tell her she was donating to a person with HIV hoping for a cure.

After she contacted me, she was diagnosed with breast cancer, and on the first day of her chemo, she got my letter. She said it made her feel that if something went wrong with her chemo, her cells had helped another person. When we first met in person, she visited me in the hospital after my hip replacement. I didn’t feel so good after the operation, and she had no hair and was wearing a wig. So we decided to meet again when everything was fine. In 2016, we got together with our partners at a little restaurant in Cologne on the Rhine. And when I celebrated the 10th anniversary of my transplant on Valentine’s Day this year, she was a guest of honor.

How did you and your doctors decide to stop antiretroviral treatment?

A year after stopping immune suppression therapy in 2017, Dr. Jensen thought it might be the right moment to stop

the antiretrovirals. Several tests were done to look for any hint of HIV. They found [virus] fragments and tested to see if it could be reactivated. They took samples from my gut and lymph nodes because they thought there might be a reservoir. All of this took much time. But I was 100% sure that if Dr. Jensen said to me, “You’re ready to stop treatment,” I was ready.

Why did you recently decide to go public with your cure?

My case was first presented as a little paper at the 2016 CROI [Conference on Retroviruses and Opportunistic Infections] before I stopped HIV treatment. Then it should have been presented together with the London Patient at CROI 2019, but an Indian newspaper broke the press embargo, and all the focus

he was dead. [Brown died in September 2020 due to a recurrence of leukemia.] In 2021, I was on stage with Adam at the Power of Love, a big meeting for the HIV community in Utrecht [in the Netherlands]. I have talked with Paul [Edmonds, the City of Hope Patient] on Zoom. Paul, Adam and I have a WhatsApp group, The Three Musketeers, where we exchange information.

What do you hope to accomplish by going public?

One of the reasons to come out with my story is to support HIV science and get more people to become donors. [Franke recommends Aidsfonds.org and DKMS .org.] Many people think that if you donate stem cells, you get a needle in your back and it will hurt a lot, but now, nearly 90% can be done via apheresis

was on Adam, and they forgot me. At that time, I thought, Well, let Adam be the focus, and I could have a normal life. I got my transplant sooner than Adam but stopped HIV treatment later because my doctors wanted to be 100% sure. Dr. Jensen is not one for publicity— he cares about me, not about his fame. In 2019, it was just three or four months after stopping the antiretrovirals. I didn’t want to be the person who had to say six months later, “Sorry, it didn’t work.” But 10 years after the transplant, I think I can say I’m cured. In 2021, I had my first interview for a Dutch newspaper, but I didn’t show my face and only gave my first name.

Have you met any of the other people who were cured?

I didn’t meet Timothy because I was not ready to go out with my story, and then

[removal of stem cells from the blood]. Another reason is to fight HIV stigma and get rid of the pictures that are still in our minds from the beginning of the ’80s, when people were dying like flies. I was a teenager then, so that had a big influence on my life.

I want to focus on cure research because I think scientists have learned so much about HIV and its reservoirs from stem cell transplants. They could see in detail how a new immune system responds to HIV. But the procedure the five of us went through is not suitable for people without leukemia or lymphoma. I hope that in the near future they can recreate this [CCR5-delta32 mutation] via CRISPR or something else—that they can make some gene magic so they have a one-shot therapy that can help people with HIV all over the world. Q

“When I celebrated the 10th anniversary of my transplant, my donor was a guest of honor.”

STUDYING HIV AMONG WOMEN IN THE SOUTH

Why are HIV rates among women in the South higher than in other regions—and what can be done to address this health disparity?

The National Institutes of Health (NIH) awarded researchers at the University of Alabama at Birmingham (UAB) a combined $19.5 million in federal grants to investigate these very questions, according to a UAB press release.

Although 38% of the U.S. population lives in the South, the region accounts for 53% of new HIV cases and 47% of all deaths among people with HIV, according to the Centers for Disease Control and Prevention. Specifically, it’s estimated that 18,500 of the 34,800 new HIV diagnoses in 2019 were in the South. What’s more, about 55% of women diagnosed with HIV in the United States live in the South, according to AIDSVu.

The NIH grants will fund two studies focusing on the ways behavioral, geographic and demographic factors relate to HIV rates among women in the South, according to the press release.

The bulk of the funding—$15 million—will go to the AWARE project, which is led by researchers at UAB, the Columbia School of Nursing in New York City and Lurie Children’s Hospital in Chicago.

The AWARE Project will enroll a national digital cohort of 1,800 HIV-negative women to study how various factors impact the risk of acquiring HIV as well as other sexually transmitted infections (STIs).

The second study, the Camellia Project, will receive $4.5 million and be co-led by Latesha Elopre, MD, an associate professor in the UAB Division of Infectious Diseases in the Marnix E. Heersink School of Medicine, and Lynn Matthews, MD, an associate professor in the UAB Division of Infectious Diseases.

In addition to HIV and STIs, the Camellia Project will also focus on access and use of pre-exposure prophylaxis (PrEP) among vulnerable cis- and transgender women in Alabama. PrEP refers to the daily pills or long-acting injectables that prevent a person from contracting HIV.

“The rate of HIV infection is 10 times higher for Black women compared to white women; however, PrEP utilization remains low,” Elopre says.

The study will identify the barriers that prevent people of color, specifically women in the Deep South, from accessing PrEP. —Laura Schmidt

FDA Eases Blood Donation Rules for MSM

But people who use PrEP cannot donate.

More gay and bisexual men will be able to donate blood now that the Food and Drug Administration (FDA) has ceased requiring men who have sex with men (MSM) to abstain from sex for three months before donating blood, according to an FDA press release.

Under the new policy, all potential donors will answer a questionnaire evaluating their individual risk, regardless of their sex or gender. Gay and bisexual men in monogamous relationships can now donate blood. According to the FDA, people who report the following will not be eligible to donate blood:

• Anyone who had a new sexual partner in the past three months

• Anyone with more than one sexual partner in the past three months

• Anyone who had anal sex in the past three months

• Anyone taking HIV medications to treat or prevent HIV, including pre- and post-exposure prophylaxis (PrEP and PEP).

Regarding the rules based on PrEP, PEP and HIV meds, the FDA explains:

“Though these antiretroviral drugs are safe, effective and an important public health tool, the available data demonstrate that their use may delay detection of HIV by currently licensed screening tests for blood donations, which may potentially give false negative results. Although HIV is not transmitted sexually by individuals with undetectable viral levels, this does not apply to transfusion transmission of HIV because a blood transfusion is administered intravenously, and a transfusion involves a large volume of blood compared to exposure with sexual contact. As stated in the guidance, individuals should not stop taking their prescribed medications, including PrEP or PEP, in order to donate blood. The FDA remains committed to evaluating additional data and new technological developments as they become available to inform our donor eligibility recommendations.”

Straube

Two projects in Alabama explore why they’re more vulnerable.

—Trent

TRAINING HIV BEHAVIORAL SCIENTISTS

A new University of Miami program combats inequities.

A new training program at the University of Miami (UM) provides young researchers with opportunities to work with some of the communities most affected by HIV health inequities.

The Culturally focused HIV Advancements through the Next Generation for Equity (CHANGE) Training Program aims to equip the next generation of HIV behavioral scientists with the skills required to address and eliminate health disparities in HIV treatment and prevention in South Florida’s Black, Latino and LGBTQ communities, according to a UM news release.

“Our program feels like a manifestation of peers, colleagues, key information, professional network and hands-on learning of community-engaged research that I wish I had access to when I was a trainee,” says CHANGE program codirector Sannisha Dale, PhD, an associate professor in the Department of Psychology, in the news release. As a self-identified “Black, HIV–health equity researcher who partners with

the community to inform change,” Dale understands firsthand the promise of the training program.

A slideshow promoting CHANGE’s kickoff explains the need for the program: “Ending the HIV epidemic remains out of reach mostly because effective strategies and scientists are needed to reach, care for and offset barriers for the communities most impacted by HIV: Black, Latinx and LGBTQ.”

Florida has consistently had one of the highest HIV rates in the nation. What’s more, the Sunshine State had the second-highest rate of new HIV diagnoses among young adults and adolescents in 2018, according to data from the Centers for Disease Control and Prevention. In 2020, Florida had the third-highest number of new HIV diagnoses, with 3,408 new cases.

Naysha Shahid, a clinical health psychology PhD candidate and one of a handful of students involved in the new program, says joining CHANGE has given her the opportunity to work with Black women and community organizations in South Florida.

“Through my participation with these organizations and my training at UM, I am working with women who look like me and helping them with HIV prevention, mental health assessment and care,” Shahid says. “This has been an amazing journey that has allowed me to help empower women and be my most authentic self.” —LS

Black gay men with AIDS were most affected. Tallying U.S. Mpox Deaths

Of the 38 people who have died of mpox (formerly monkeypox) in the United States, most were Black cisgender gay men, and among those with a known HIV status, all had AIDS and only two were on antiretroviral treatment, according to an analysis by the Centers for Disease Control and Prevention (CDC).

Mpox cases have declined dramatically since the outbreak peaked late last summer, but it remains a risk for people living with HIV, who have accounted for around half of all U.S. cases.

HIV-positive people on antiretroviral therapy with an undetectable viral load and an adequate CD4 T-cell count do not fare worse with mpox than their

HIV-negative peers, but it’s a different story for those with advanced immune suppression.

A previous CDC analysis found that more than 80% of people hospitalized with severe mpox in the United States were living with HIV. Most of them were Black men who were not on antiretroviral treatment. The good news is that no one with well-controlled HIV died, suggesting that antiretrovirals can prevent severe outcomes.

In the latest analysis, Aspen Riser, MPH, of the CDC’s Mpox Emergency Response Team, and collaborators from more than a dozen city and state health departments looked at the epidemiological and clinical

features of mpox-associated deaths in the United States from May 10, 2022—at the start of the global outbreak— to March 7, 2023. During this period, the CDC tallied 30,235 confirmed and probable mpox cases. Throughout the outbreak, most people with mpox were gay and bisexual men.

During the same period, the CDC received reports of 52 deaths among people with confirmed or probable mpox. Of these, 38 had mpox as a cause or contributing factor, for a rate of 1.3 mpox-associated deaths per 1,000 cases. Three people died of other causes (including one suicide), and 11 deaths were still under investigation.

“These findings highlight

Highleyman

the importance of integrating prevention, testing and treatment for multiple sexually associated infections,” the study authors wrote. “Equitable access to prevention, treatment and engagement and retention in care for both mpox and HIV should be prioritized, particularly among Black men and other persons at risk for sexually associated infections.” —Liz

RUSSIAN PRISONERS JOIN WAR AGAINST UKRAINE

About 20% of prisoner recruits have HIV.

Would you prefer a quick or slow death? Many incarcerated Russians living with HIV feel that’s the choice they face when deciding whether to remain in prison or serve in Russia’s war against Ukraine, reports The New York Times.

Incarcerated Russians with HIV say they don’t have access to lifesaving treatment—or at least to meds they think actually work, which means they’d eventually die of AIDS-related illness in prison, or a “slow death.”

Conversely, if they volunteer to serve in the war in exchange for a pardon and effective HIV meds, they’d likely meet a “sudden death” on the battlefield, as one soldier explained it. Such volunteers are often ordered to engage in risky combat with little training.

About 10% of Russia’s prison population is HIV positive, according to the New York Times. Hepatitis C and

tuberculosis are also prevalent among the incarcerated. About 50,000 prisoners have volunteered for the Russian forces since last summer, accounting for about 10% of the country’s incarcerated population.

Ukrainian military experts have reported capturing Russian soldiers living with HIV and hepatitis C. Such soldiers are easily identified by the color-coded wristbands they’re made to wear (white for hepatitis C, red for HIV) to alert fellow soldiers of their status in the event that they are wounded and pose a potential health risk.

Russia invaded Ukraine in February 2022, with Russian President Vladimir Putin recruiting hundreds of thousands of male citizens against their will. According to previous reporting, to avoid the draft, citizens have resorted to breaking their own limbs and purchasing fake diagnoses for HIV

and hepatitis C, though now it seems a diagnosis wouldn’t necessarily disqualify one from service.

In the United States, people living with HIV and hepatitis C are not allowed to enlist in the military; last fall, some members of Congress pressured the Biden administration and the Department of Defense to allow those with HIV and hep C to serve.

In addition, a federal judge last spring struck down Pentagon policies that discharged and denied promotions to service members who contracted HIV.

—Trent Straube

These dates represent milestones in the HIV epidemic. Visit poz.com/aidsiseveryday to learn more about the history of HIV and AIDS.

BY JENNIFER MORTON

July 2

August

Drug manufacturer ROCHE sends an email to HIV treatment activists announcing that it is terminating its in-house research into new HIV drugs. (2008)

With the signing of HB20-1061, COLORADO becomes the first state to allow pharmacists to prescribe pre- and post-exposure prophylaxis (PrEP and PEP) to prevent HIV. (2020)

9 13 27

FRANÇOISE BARRÉ-SINOUSSI, a French virologist who was awarded the 2008 Nobel Prize in Physiology or Medicine for codiscovering HIV in 1983, becomes the new president of the International AIDS Society. (2012)

CHRISTODORA, a novel by Tim Murphy about a group of characters whose lives are connected by HIV and an apartment building in New York City’s East Village, is released. (2016) 6

Performer KLAUS NOMI dies of AIDS-related causes at age 39. (1983)

SOUTHERN HIV/AIDS AWARENESS DAY

NATIONAL FAITH HIV/ AIDS AWARENESS DAY

THE MIFEPRISTONE DECISION

ARADICALLY CONSERVATIVE, Trump-appointed judge in Texas ruled in April to halt the Federal Drug Administration’s (FDA) approval of the safe, e ective and commonly used medication abortion drug mifepristone (“mife”), which is used along with misoprostol (“miso”) to terminate pregnancies. The ruling is not in e ect and is being considered by the Supreme Court. But it could lead to a nationwide ban of this drug.

The ruling was anticipated by reproductive justice advocates, but it was still devastating. We are heartbroken and worried. As we said last year, the overturning of Roe v. Wade was just the beginning of many attacks on reproductive freedom and bodily autonomy.

Medication abortion accounted for more than half of all abortions in 2020. If a mife ban goes into e ect, Black, Indigenous and people of color and low-income communities will once again be most harmed. Medication abortion is the most common, least invasive, most private, least expensive and most accessible way for people to terminate pregnancies. Losing legal access to mife means that communities that are already hyper-policed and surveilled will face greater risk of interactions with police

based on personal health decisions.

More than 100 studies conducted in 26 countries over a 30-year period have shown that abortion pills are safe and e ective. This ruling was not about science, just like the recent pre-exposure prophylaxis (PrEP) ruling out of Texas that undermined the A ordable Care Act preventive services requirement by singling out PrEP was not about science, just like the legislation sweeping state legislatures that targets trans and gender-nonconforming people and those who love them isn’t about science.

And once again, the silence from the HIV community—as in, zero acknowledgment on federal HIV policy listservs of the devastating mife court decision; as in, PWN-USA members and allies being asked by partners on a recent state HIV advocacy day to remove “abortion access” language from a list of policy priorities—speaks volumes. The continued failure to address reproductive rights and sexual freedom for all people living with HIV in the National HIV/AIDS Strategy 2022–2025 Federal Implementation Plan is just another example of the ways misogynoir is baked into the domestic HIV response. We can’t ght for PrEP and for decriminalization of HIV and not also

ght for abortion medications and for science—not ideology—to be centered in FDA approval processes. These struggles are connected.

Courts, judges and elected leaders don’t keep us safe. We keep us safe. Here are three actions you can take:

1. Stay informed. Go to pwn-usa.org for updates.

2. Demand change at the federal level. Tell the U.S. Congress that it must pass the Women’s Health Protection Act (WHPA). The WHPA is federal legislation that would protect abortion access in every U.S. state, no matter what the Supreme Court has said or will say about the right to abortion. All people—regardless of where they live or their gender, race, ethnicity, immigration status or ability to pay—should be able to control what does and does not happen to their bodies, including choosing the method of abortion that works best for them without barriers or delay.

3. Mobilize! Sign up to receive updates from your local Planned Parenthood and the Women’s March so you can be ready to show up in your hometown when needed.

We will never stop building power and working to transform these racist, oppressive, patriarchal systems. Q

Positive Women’s Network–USA (PWN-USA) connects attacks on transgender people, reproductive rights and PrEP in a blog post titled “Why Does the Mifepristone Decision Matter for the HIV Community?” Below is an edited excerpt.

CARROT & ORANGE SOUP

THIS WONDERFULLY EASY SOUP is best enjoyed chilled on a hot day. It’s light, a little sweet and very soothing, and the color is heavenly. For some extra calories, drizzle a little olive oil onto it or stir in a dollop of plain Greek yogurt. It’s delicious either way.

SERVINGS: 6 / INGREDIENTS: 6 / PREP: 15 MINUTES

INGREDIENTS

¼ cup olive oil

4 cups carrots, chopped

DIRECTIONS

¼ cup shallots, chopped

6 cups low-sodium vegetable stock

1 cup orange juice

Salt and pepper, to taste

1. In a medium pot, heat olive oil over a medium high flame. Add carrots and shallots to the pot, and cook a minute. Then lower the flame to medium, and sweat until soft, about 5 minutes.

2. Pour in vegetable stock, raise the flame to medium high and bring to a simmer. Cook for about 15 minutes, or until the carrots are cooked through and soft.

3. Remove the soup from the heat. Pour soup into a blender and puree until smooth. Blend hot liquids in batches, filling the blender only halfway. (Hot liquids expand in the blender and can blow the top off and scald.)

4. Pour orange juice into pureed soup and stir. Season with salt and pepper to taste.

5. Serve warm or chilled.

CHEF TIPS

For a more intense orange taste, add a teaspoon of finely grated orange zest to the oil along with the carrots and shallots.

NUTRITION FACTS (per serving)

Calories: 148; fat: 10 g; saturated fat: 1 g; polyunsaturated fat: 1 g; monounsaturated fat: 7 g; carbohydrates: 16 g; sugar: 9 g; fiber: 3 g; protein: 2 g; sodium: 877 mg

TRY GREEN EXERCISE

By Craig Ramsay

The physical perks of working out at home or at the gym are endless, but studies have shown that exercise performed outdoors can also boost your mood and self-esteem. Green exercise is any physical activity or exercise that is done in nature. That could mean a park, a backyard garden, a nature trail or any other outdoor space. So whether it’s walking, jogging, cycling or swimming, head outdoors and reap the benefits of going green.

k)UHG+XWFKLQVRQ&DQFHU5HVHDUFK&HQWHUDFQRQSURƓW organization. Used with permission.

Craig Ramsay is a fitness expert, an author and a winner of season 8 of The Amazing Race Canada Follow him on Instagram at @craigramsayfit.

It’s light, a little sweet and very soothing.

Register Today!

September 6-9, 2023

Marriott Marquis

Washington DC USCHA.life • #2023USCHA

PrEP for Women PREVENTION

Cisgender women who consistently take TDF/FTC (Truvada or generic equivalents) for pre-exposure prophylaxis (PrEP) are protected as well as gay men, but a majority don’t achieve high enough adherence. In an analysis of nearly 3,000 women in 11 PrEP demonstration projects, mostly in Africa and India, only 39% had adequate adherence. There were no new HIV diagnoses among women with consistent daily adherence (seven pills per week) and only one among those with consistently high adherence (four to six pills). But HIV incidence rates were higher among those with high but declining PrEP adherence or consistently low adherence. In another study, researchers analyzed data from two trials that compared daily TDF/FTC (tenofovir disoproxil fumarate/emtricitabine) versus long-acting Apretude (cabotegravir) injections. They calculated that men achieved 99% efficacy at a lower adherence threshold of two or more pills per week, while women required daily dosing, suggesting higher adherence is needed for women.

Back on Track TREATMENT

Merck and Gilead Sciences have resumed a Phase II clinical trial of a weekly oral HIV treatment regimen that combines a lower dose of Merck’s experimental nucleoside reverse transcriptase translocation inhibitor islatravir and Gilead’s new HIV capsid inhibitor Sunlenca (lenacapavir). In December 2021, the Food and Drug Administration placed a hold on islatravir trials after study participants showed declines in CD4 and total lymphocyte counts. Merck scientists determined that the islatravir doses used in those trials were too high, and people who took lower doses did not have notable lymphocyte changes. A 0.25 milligram dose of islatravir is now being tested with Pifeltro (doravirine) as a once-daily regimen, and a 2 mg dose is being studied with oral Sunlenca as a once-weekly regimen. In the latter trial, people who have taken the daily Biktarvy pill (bictegravir/tenofovir alafenamide/emtricitabine) for at least six months and have an undetectable viral load will be randomized to either stay on Biktarvy or switch to weekly low-dose islatravir plus Sunlenca pills.

Dual CRISPR CURE

Researchers have developed a combination approach that aims to eliminate HIV using two types of CRISPR, a gene-editing tool that acts as molecular scissors to cut out selected segments of DNA. Antiretroviral therapy can keep HIV replication suppressed, but the virus inserts its genetic blueprints into the DNA of human cells and establishes a long-lasting reservoir that makes a cure nearly impossible. Researchers tested a dual CRISPR approach in mice with humanlike immune cells. One CRISPR tool targets genes for the CCR5 receptor, which most strains of HIV use to enter CD4 T cells, while the other snips out integrated HIV genes in cells that are already infected. They found that replication-competent HIV was eliminated in 58% of mice that received slow-release antiretrovirals plus both types of CRISPR. Using highly sensitive tests, they could not detect intact HIV in the blood, spleen, lungs, kidneys, liver, gut, bone marrow or brain. The researchers next plan to test the dual CRISPR approach in monkeys before moving on to human trials.

Sleep Problems CONCERNS

People with HIV are more likely to experience sleep disorders than their HIVnegative peers. Sleep disturbances—such as insomnia and sleep apnea—can affect daily functioning, long-term health and overall quality of life. Prior research has shown that sleep disorders are more common among people with HIV, and certain antiretroviral drugs can interfere with sleep. In a new study, researchers analyzed sleep problems among 721 HIV-positive people in Italy. All were on stable antiretroviral treatment, most with an undetectable viral load, but comorbidities were common, and 20% were taking multiple medications. Overall, 77% had sleep disorders. A majority had scores indicating poor sleep quality (60%), followed by sleep apnea (31%), insomnia (31%) and high daytime sleepiness (8%). In this study, sleep problems were associated with anxiety and depression, cardiovascular risk factors and medications that can affect sleep but not with specific antiretrovirals. The researchers suggested that inflammation and chronic immune activation might also play a role.

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STATIN REDUCES CARDIOVASCULAR RISK

The REPRIEVE study, a large international trial testing a statin drug for people with HIV, was halted ahead of schedule after interim results showed that the medication significantly reduces the risk for heart attacks, strokes and other major cardiovascular events.

A large body of research has shown that people living with HIV are at greater risk for cardiovascular disease. Statins, which lower cholesterol, reduce the risk for cardiovascular events and death in the general population, but their benefits for people with HIV were unknown.

REPRIEVE, the largest randomized HIV trial to date, enrolled nearly 7,800 HIV-positive people ages 40 to 75 who were on stable antiretroviral therapy. They had no prior history of cardiovascular disease and had comorbidities and laboratory values indicating low to moderate risk—a population that normally would not be advised to use statins. The study showed that participants randomly assigned to take pitavastatin once daily had a 35% lower risk for major cardiovascular events than those who took a placebo pill.

“The REPRIEVE study reflects the evolution of HIV science and progress from focusing mostly on approaches to treat and control the virus to finding ways to improve the overall health of people living with HIV,” says Hugh Auchincloss, MD, acting director of the National Institute of Allergy and Infectious Diseases.

U.S. Meets Perinatal HIV Elimination Goals

In 2019, the United States met its goals for the elimination of HIV among newborns for the first time, according to a recent report in the journal Pediatrics. Although it has not yet reached zero, the likelihood of mother-to-child transmission fell below 1%, and the perinatal HIV diagnosis rate dropped below one case per 100,000 live births.

Pregnant women living with HIV can transmit the virus to their babies, but effective antiretroviral treatment dramatically reduces the risk. Modern antiretroviral therapy that leads to full viral suppression makes transmission virtually impossible, but the risk remains high if women are not diagnosed with HIV until late in pregnancy. Elimination of perinatal HIV therefore requires universal testing during pregnancy and treatment for those who test positive.

Researchers with the Centers for Disease Control and Prevention assessed perinatally acquired HIV among babies born in the United States between 2010 and 2019. The annual estimated number of live births to women diagnosed with HIV decreased from 4,587 in 2010 to 3,525 in 2019, while the number of infants with perinatally acquired HIV dropped from 74 to 32—down from a peak of more than 1,500 per year in the early 1990s. The perinatal HIV transmission rate fell from 1.6% to 0.9%, and the annual perinatal diagnosis rate declined from 1.9 to 0.9 cases per 100,000 live births. Racial and ethnic disparities persist, but they declined substantially over the 10-year study period.

“These laudable accomplishments have been made possible through the decades-long coordinated multidisciplinary and multisectoral efforts of HIV research, public health agencies and advocacy communities,” Nahida Chakhtoura, MD, and Bill Kapogiannis, MD, of the National Institutes of Health, wrote in an accompanying editorial.

Do Natural Controllers Need Treatment?

People with HIV who naturally control the virus without antiretroviral therapy were about twice as likely as HIV-negative people to develop non-AIDS-defining health problems, raising questions about whether they should receive treatment.

While most people with untreated HIV have a substantial viral load and a declining CD4 count and eventually experience disease progression, a small proportion—estimated to be less than 1%— maintain a very low viral load without antiretrovirals. Nonetheless, untreated HIV may result in persistent immune activation and inflammation that can lead to a wide range of health problems.

Carmelite Manto, of Université Paris Saclay, and colleagues compared outcomes among 227 spontaneous HIV controllers and 328 people on antiretroviral therapy from two French cohorts. People in the first group had been HIV positive for at least five years, had never taken antiretrovirals and had at least five consecutive viral load measurements below 400. Those in the latter group started antiretrovirals within one month after a primary HIV diagnosis, achieved an undetectable viral load within 12 months and maintained viral suppression for at least five years.

During follow-up, 68 people in the HIV controller group and 62 people on antiretroviral treatment experienced non-AIDS-defining events. Rates of non-AIDS cancers and cardiovascular, pulmonary, liver and psychiatric events were similar in both groups. But HIV controllers had two times more non-AIDS infections, none of which were severe.

These results, the study authors suggest, “do not argue in favor of expanding the antiretroviral therapy indication for [HIV controllers] but rather a case-by-case approach considering clinical outcomes such as non-AIDS-defining events besides immune activation.”

HIV AMONG TRANS MEN

Transgender men and transmasculine people in the United States have a higher rate of HIV than the general population, but this appears to be largely driven by those who have sex with cisgender men.

Research on HIV among transgender people has historically been scarce. Studies of transgender women have increased in recent years, showing that they have a high rate of HIV. But data on trans men remain limited.

Asa Radix, MD, PhD, of Columbia University’s Mailman School of Public Health, and colleagues assessed HIV prevalence among transgender men and transmasculine people who received care between January 2009 and December 2010 at Callen-Lorde Community Health Center in New York City, a clinic specializing in care for the LGBTQ community. The analysis included 577 people who were assigned female at birth and currently identify as transgender men, transsexual men, FTM/ female-to-male, gender nonconforming or genderqueer.

HIV screening was suboptimal, with just 43% having ever been tested. Of the 250 people screened, seven tested positive, for an overall HIV prevalence of 2.8%. But the prevalence was about twice as high for trans men who had sex with cisgender men compared with those who had sex with cisgender women (3.5% versus 1.8%, respectively).

“These findings have important implications for clinicians, researchers and policymakers, since transgender men are often not included in HIV prevention research and are not prioritized for HIV prevention intervention efforts,” the study authors wrote.

Josh Kruger in front of the Keith Haring mural in Philadelphia

LONG-ACTING INJECTABLES MADE JOSH KRUGER RETHINK

HIV TREATMENT, ACTIVISM AND THE SIZE OF HIS BUTT.

BY JOSH KRUGER

PHOTOGRAPHY BY GENE SMIRNOV

“MY ONLY CONCERN,” MY DOCTOR SAID TO ME WITH a tremendously heavy pause, “is that you’re working with a lot back there.” This was the politest way I’ve ever heard someone say I have a fat ass.

I could see why he approached the topic so deliberately. One of the best HIV doctors in Philadelphia, he was part of the Cabenuva approval study here and is now also an expert at dealing with my mercurial personality and occasional, sometimes warranted and sometimes not, outbursts.

I had been excited about the prospect of the new injectable HIV treatment Cabenuva, which includes injections of two meds, cabotegravir and rilpivirine, administered by a health care provider monthly or every other month. So any concern— let alone this concern—was a touchy subject. Besides, my mom used to buy me jeans from the husky section at JCPenney. And while my doctor’s observation is today truly a compliment based upon feedback from men I date, it’s still a subject fraught with anxiety and insecurity.

It’s sort of like my relationship with HIV. It’s not that I ever wanted to be HIV positive. But it’s so a part of who I am now that, well, it’s complicated.

For about a decade, I’ve been taking one pill once per day every day. I’ve never noticed any side effects, though one could argue some weight gain might’ve been attributed to them.

Adherence has been part of my life. Getting access to my meds when I was unemployed, uninsured, even homeless at one point, wasn’t just a key priority. It was the priority.

As a result, I have experienced few if any HIV-related complications. There’s still so much work to do—just over half (55%) of HIV-positive people in Philadelphia, where I live, are on treatment and virally suppressed. Nationwide, the figures are only slightly better, at 64%.

Even so, the idea of tossing the pills entirely for a visit to the doctor once every two months was going to take some getting used to, albeit now jeopardized by a flesh-and-blood peach emoji.

“My ass is so fat you’re concerned I can’t take the injection?” I asked, bemused. I gained weight during the COVID quarantine, but was it really that much?

“No, no, we can do this,” he assured me. “We just have to make sure. We might need a bigger needle.”

“I say that to dates all the time,” I quipped. Balance the tragedy and trauma with a cheap laugh, I say.

ALL BAD

JOKES ASIDE,

THE NEW RHYTHM OF treatment would take some getting used to.

First, we have to make sure I’m still undetectable, as I’ve been for almost a decade. Then, we schedule the day for the first treatment—two injections, one into the muscle on the upper part of each butt cheek. I should continue to take my pills about four days after the first treatment before stopping entirely. Thirty days later, I get another two injections as part of my starter dose. After that, I go every two months for the same treatment, all the while getting my blood drawn to make sure everything is going as planned.

Simple. Kind of?

Having repeated the “one pill once per day” mantra for nearly a decade, my first impulse was to embrace the supposed freedom of no pills at all. Pill-based treatment seems simple, but those viral suppression figures tell a different story. Plainly, if it’s so simple, why are so few people undetectable?

Hinging lifesaving care on one’s ability to maintain access to medication and take that medication, no matter what, every single day is great until you can’t do that anymore. More to the point, you can’t take your meds if you

don’t have a place to store them. It’s hard to get something refilled if you’re too depressed to do the things necessary to stay connected to care.

In one study published in February 2022’s BMC Infectious Diseases, researchers found that “homeless patients were half as likely to achieve viral suppression as compared to those who had a permanent or stable home.” Researchers, including Vladimir Berthaud, MD, MPH; Livette Johnson, MD; and Ronda Jennings, reported that study participants who were undetectable, with a viral load of less than 20 copies of HIV per milliliter of blood, were overwhelmingly stably housed.

“While 74% of permanently housed patients reached viral suppression,” they wrote, “a much smaller proportion of the

Josh Kruger explored the pros and cons of switching.

homeless patients (54.7%) remained virally suppressed.” Having been homeless myself, I know too well the difficulty posed by maintaining HIV treatment while trying to fix everything else.

So it makes sense to circumvent the process entirely with the injections. Yet even in studies where the injections are given high marks by consumers, their efficacy is more or less the same as the pills in terms of HIV treatment. Conversely, emerging studies of Apretude (cabotegravir), an injectable medication used as pre-exposure prophylaxis (PrEP), where HIV-negative people take medication to prevent HIV, show that injections are even more effective than their pill counterparts.

The record, then, puts injectables in an equal or superior place compared with traditional treatments. This makes it a particularly effective tool in the “HIV treatment and prevention toolbox” that advocates and providers so often talk about. Of course, injectables won’t end the epidemic. No single treatment will. But they seem to offer an alternative intervention that HIV-positive consumers prefer—in one study, 98% of people preferred Cabenuva over their previous pill regimen—that’s also even more effective at preventing HIV among HIV-negative people.

STILL, THE IDEA THAT PEOPLE WILL BE ABLE TO

readily schedule appointments months in advance and follow through is not exactly an established fact. It’s possible that the people most likely to benefit from and need bimonthly injectable HIV medication—those with intermittent connections to care or unstable housing or who are members of traditionally underserved communities—are going to be the least likely to adopt Cabenuva as a treatment.

Whether we’ve learned anything from PrEP access and can apply that to Cabenuva isn’t yet clear. But we’re missing an opportunity if we don’t. “Black people in the U.S. represent less than 10% of PrEP prescriptions, but we represent 40% of new HIV cases,” national HIV consultant Leisha McKinleyBeach explained to WordInBlack.com writer Alexa Spencer. “You know, something is wrong with that picture.”

Unless America finally gets serious about its equity efforts, the same structural barriers and problems we find in treatment or PrEP access overall will likely plague injectables, regardless of how much people on injectables say they prefer them.

This doesn’t mean they’re something to dismiss as irrelevant to all but the most privileged, though. In my case, while I am a cisgender white guy, I’m also currently accessing the treatment via Medicaid while living in America’s poorest big city.

For me, around the 29th of every month is treatment day. I can’t go more than a week before or after that date. Since I get it every other month, I check to see if treatment is happening that month or if it’s one of my “byes,” as the NFL calls its off weeks. I break it down this way so I can remember and explain it to people.

Part of me doesn’t trust it. What if my ass really is too fat? No pills? No “proof” I’m being treated and not just saying I’m

undetectable as some people worry about? Being under 40 with a grandma-style pill organizer is something I won’t miss, but it’s been part of my life all this time. When the pills go, does part of who I am go with them?

These questions are trivial, though, when you zoom out to the entire HIV-positive population.

If those figures for viral suppression are what they are now, will they improve as more people switch to Cabenuva or similar treatments with such a relatively complex process to start? And if someone has trouble with adherence to something as simple as one pill once per day, what are the chances they’ll remember “two injections done twice separated by 30 days and then one two-injection round every 60 days thereafter?”

And have we started learning anything about equity and treatment access, or are we just churning out reports with recommendations to meet diversity and inclusion requirements that come with federal grants—and then leaving those reports in drawers or on rarely visited PDF download pages hosted by state and local public health agencies?

AT THE END OF THE DAY, HEADY CONCERNS

like these weren’t strong enough to overcome the clear scientific evidence showing that Cabenuva is, arguably, superior to pill regimens. I was sure I’d regret not at least trying it.

“So are we doing this?” my doctor asked me.

We worked out a day for me to come back. I had to get my labs checked again. Once they came back fine, the order would be put through the pharmacy, though the treatment is done in the doctor’s office. Suddenly, I got nervous again. It was more of an excited nervous, to be sure.

The data were just too convincing, so I ignored the jitters and prepared to never again have to say, “I take one pill once per day,” in reference to my HIV treatment.

Now, it would be, “I get two shots once every other month.”

Maybe it’s not a slicker slogan. But, based upon the research, I’ll have a near 100% chance of preferring it. Q

“WHEN THE PILLS GO, DOES PART OF WHO I AM GO WITH THEM?”

LONG-ACTING THERAPIES ARE THE FUTURE OF HIV TREATMENT AND PREVENTION.

BY LIZ HIGHLEYMAN

FROM HANDFULS OF PILLS TAKEN multiple times a day to injections administered every other month, antiretroviral therapy has come a long way. HIV treatment is now more effective, better tolerated and much more convenient, which promotes good adherence. What’s more, long-acting pre-exposure prophylaxis (PrEP) offers even better protection than daily pills.

“Long-acting injectables are a significant advance that offers important additional options for treatment of people with HIV and prevention in those who are candidates for PrEP,” Daniel Kuritzkes, MD, of Brigham and Women’s Hospital, told POZ. “It is likely that future advances will allow even less frequent dosing than the current monthly or everyother-month dosing now required, perhaps reducing dosing to just once or twice a year.”

Studies have shown that people who switch from daily oral antiretrovirals to long-acting injectable treatment or PrEP report greater satisfaction. (See “I Stopped Taking My HIV Pills,” page 20.) Some of the reasons for preferring periodic injections include not having to think about HIV treatment or prevention every day, not needing to remember to take daily pills, not carrying pills when away from home, less worry about medications being lost or stolen and not having pill bottles that could reveal one’s HIV-positive status or risk for HIV.

“We often think stigma occurs in specific communities, but in the SOLAR study, which was predominantly white men, stigma and disclosure came up very strongly as reasons for taking long-acting treatment,” says Chloe Orkin, MD, of Queen Mary University of London. “Even in 2023, in areas where there are Pride parades, people still feel stigma. People want to be released from the burden of daily oral therapy.

“Daily pill-taking for treatment is difficult, but for prevention, it’s even harder,” she adds. “There’s been very poor uptake of PrEP among women. I think if it were not visible, it might be better accepted, as seen with long-acting reversible contraception being far more popular than pills.”

Long-acting treatment and prevention are potentially revolutionary, but cost and limited availability can throw up barriers. In addition, long-acting injectables currently cannot be selfadministered, meaning people must visit a health care provider up to 12 times a year. Such barriers can be overcome, but to really change the game, equitable access is critical.

“It’s important that long-acting therapy is available everywhere and it’s not a treatment for some people and not for others,” Orkin says. “Continued efforts are needed to make sure this is universally available. In terms of PrEP, it’s important that things move quickly in all countries.”

WHAT’S AVAILABLE NOW?

Cabenuva (injectable cabotegravir and rilpivirine), from ViiV Healthcare and Janssen, is currently the only complete longacting HIV treatment regimen. Approved by the Food and Drug Administration (FDA) in January 2021, it involves two intramuscular injections in the buttocks administered once monthly or every other month by a health care provider.

The ATLAS trial showed that people who switched from a standard oral regimen to monthly Cabenuva were as likely to maintain an undetectable viral load as those who stayed on daily pills. The ATLAS-2M study showed that participants who received the injections every eight weeks responded as well as those who did so every four weeks, with 94% in both groups maintaining viral suppression. A recent long-term follow-up analysis found that Cabenuva remained effective at three years. However, participants with virological failure in the every-other-month group were more likely to develop drug resistance than those in the once-monthly group, suggesting that on-time injections are even more important with less frequent dosing.

The SOLAR study found that Cabenuva taken every two months maintained viral suppression for people who switched from the daily Biktarvy combination pill (bictegravir/ tenofovir alafenamide/emtricitabine). Finally, the FLAIR trial found that Cabenuva is also highly effective for first-line treatment. Across the studies, the most common side effect was mostly mild to moderate injection site reactions, which participants found acceptable.

“It’s going to be a trade-off between the burden of daily oral therapy versus the freedom of two-monthly treatment with the potential for resistance in a very small number of people. It’s important that people have the chance to make their own decisions,” says Orkin, who led the FLAIR study (see Heroes, page 32).

So far, Cabenuva is approved only for adults and adolescents who already have an undetectable viral load and wish to switch to a more convenient regimen. But it may also be a feasible approach for people starting treatment for the first time and those who have been unable to achieve or maintain viral suppression due to challenges with adherence.

Susan Swindells (left) and Chloe Orkin present results from the ATLAS and FLAIR trials.

Monica Gandhi, MD, MPH, and her team at San Francisco General Hospital’s Ward 86 HIV clinic evaluated outcomes among 133 people who switched to Cabenuva from a daily oral regimen. Two thirds were homeless or lacked stable housing, and many were dealing with substance use and mental health problems. They received intensive support, including case management, phone or text reminders of upcoming injection visits, follow-up for missed appointments and even street-based nursing services.

A majority of the study participants already had an undetectable viral load on their current medications, and all of them maintained viral suppression after switching to the injections. The more exciting finding was that outcomes were nearly as good for the 57 people who started with a detectable viral load: All but two achieved viral suppression.

“For those of us treating HIV on a daily basis, we know that some patients have challenges taking pills, including substance use, housing and food insecurity and stigma,” Gandhi told POZ. “By trying to use these novel agents in patients with concomitant life challenges, we hope to get individuals suppressed on therapy who have never been suppressed before and change the trajectory of the HIV epidemic.”

For HIV prevention, ViiV’s Apretude (injectable cabotegravir alone), approved by the FDA in December 2021, is currently the sole long-acting PrEP option. According to the Centers for Disease Control and Prevention, only about 25% of the more than 1 million people who could benefit from PrEP have received a prescription for it. A prevention method that doesn’t have to be taken daily could potentially increase uptake and adherence.

Two large trials showed that Apretude administered every other month works even better than daily tenofovir disoproxil fumarate/emtricitabine PrEP pills (Truvada and generic equivalents). HPTN 083, which enrolled more than 4,500 cisgender men and transgender women who have sex with men, showed that the injections were 69% more effective at prevent-

ing HIV acquisition— a remarkable finding, given that daily oral PrEP reduces the risk of HIV acquisition by about 99% for gay and bisexual men who use it consistently. HPTN 084, which compared Apretude versus daily PrEP pills for more than 3,000 mostly young cisgender women in Africa, found that the injections were about 90% more effective.

Cabenuva and Apretude currently must be administered by a health care provider, but this could change. Recent studies found that highconcentration formulations of injectable cabotegravir and rilpivirine could allow for lowervolume shots and that alternative injection sites—such as the thigh or belly—are feasible. This suggests that people could potentially administer long-acting treatment or PrEP themselves, meaning fewer clinic visits and less need for health care staff and resources.

WHAT’S IN THE PIPELINE?

Injectable antiretrovirals taken less often than every other month, as well as longer-acting oral therapies, could further increase convenience and improve adherence to HIV treatment and PrEP.

Gilead Sciences’ Sunlenca (lenacapavir), the first HIV capsid inhibitor, was approved last December but only for treatment-experienced adults with multidrug-resistant virus who are unable to maintain viral suppression on their current regimen. Trogarzo (ibalizumab), an injection every two weeks, is also approved for heavily treatment-experienced adults. Both are good news for long-term survivors who used suboptimal drugs early in the epidemic and developed resistance that leaves them with few treatment options.

Sunlenca is available as an injection given once every six months and as a pill that is currently used only as a loading dose prior to injections. In the CAPELLA trial, twice-yearly Sunlenca injections plus an optimized background regimen led to viral suppression in more than 80% of treatmentexperienced people with highly resistant HIV. The participants had been living with HIV for 24 years, on average, and they

Daniel Kuritzkes (left) and Dázon Dixon Diallo

“LONG-ACTING THERAPY WON’T MATTER IF PEOPLE DONT KNOW ABOUT IT, HAVE CONFIDENCE IN IT OR HAVE ACCESS TO IT.”

had previously tried a median of 11 antiretrovirals. The response rate was lower (67%) for people with no other fully active drugs in their background regimens, but still quite impressive given such highly resistant virus. CD4 T-cell counts rose, and the proportion of people who met the criteria for AIDS (less than 200 CD4 T cells) fell from 75% to 40%.

Sunlenca also works well for people new to treatment, but it is not yet approved for this indication. The CALIBRATE trial showed that 85% to 90% of participants who received Sunlenca injections every six months along with a single daily oral antiretroviral (tenofovir alafenamide or bictegravir) had an undetectable viral load after a year of treatment. In both studies, Sunlenca was safe and generally well tolerated; here, too, the most common side effect was mild to moderate injection site reactions.

As it stands, Sunlenca must be taken with daily pills for HIV treatment, thereby limiting its promise as a twice-yearly option. Targeting two or more steps of the viral life cycle is necessary to keep HIV in check over the long term, but so far,

Sunlenca has no equally long-acting partners to make up a complete semiannual regimen.

On the other hand, solo Sunlenca shows promise as a twice-yearly option for PrEP. While combination therapy is needed to fully control HIV, a single drug can be enough to prevent the virus from taking hold in the body.

Oral agents with extended anti-HIV activity are also in the pipeline. Merck’s islatravir, the first nucleoside reverse transcriptase translocation inhibitor, stays in the body long enough to allow for once-weekly dosing. Islatravir also shows potential for HIV prevention. Unfortunately, the FDA put clinical trials of islatravir on hold in December 2021 after HIV-positive participants in treatment trials experienced declining CD4 counts and HIV-negative volunteers in PrEP studies saw a drop in their total lymphocyte counts.

But Merck was not ready to give up on islatravir. Company scientists conducted an extensive analysis to better understand the problem, determining that the doses used in these trials were probably too high. People who took a lower dose

BROADLY NEUTRALIZING ANTIBODIES

MOST PEOPLE LIVING with HIV make antibodies against the virus, but HIV mutates rapidly and is usually able to escape them. However, a small proportion of people produce broadly neutralizing antibodies (bnAbs) that target parts of the virus that don’t change very much. Engineered versions of these antibodies are now being studied for prevention, treatment and a functional cure.

The Antibody-Mediated Prevention (AMP) trial showed that a bnAb dubbed VRC01 had little e ect on most strains of HIV, but it did

lower the risk of acquiring virus strains that were sensitive to the antibody by 75%. Experts predict that they might have more success using cocktails of bnAbs to overcome resistance. Scientists are also working on experimental mRNA vaccines designed to train immature B cells to produce bnAbs in the body.

For treatment, researchers at Rockefeller University tested a combination of two bnAbs (10-074 and 3BNC117) given at two- to three-week intervals over ve months in people with chronic HIV. They found that the antibod-

ies delayed viral rebound a er stopping antiretroviral therapy: 13 out of 17 participants who discontinued antiretrovirals two days a er the rst bnAb infusions maintained viral suppression for at least ve months, and two people did so for a year.

This approach might work better for people who start antiretroviral treatment at an early stage of HIV infection. In one study, 14 people received up to eight monthly infusions of 10-074 and 3BNC117 or a placebo. None of the seven participants who received the bnAbs had to restart antiretrovirals

“STIGMA AND DISCLOSURE CAME UP VERY STRONGLY AS REASONS FOR TAKING LONG-ACTING TREATMENT.”

had CD4 and total lymphocyte changes comparable to those seen in people on standard daily therapy. Merck thus resumed Phase III studies testing a 0.25 milligram dose of islatravir in a daily regimen with Pifeltro (doravirine), while Merck and Gilead restarted a Phase II trial assessing a once-weekly combination of 2 mg islatravir plus Sunlenca pills.

The future of islatravir for HIV prevention is murkier. Company-sponsored studies of once-monthly islatravir for PrEP have been discontinued due to side effects, but independent researchers are continuing to evaluate long-lasting islatravir implants that could potentially offer protection for years, like long-acting contraceptives.

As reported at this year’s Conference on Retroviruses and Opportunistic Infections, one research team tested a refillable islatravir implant that could last for several years, while another evaluated a biodegradable implant. Both implants protected female monkeys against vaginal infection with an HIV-like virus, and the refillable implant also protected male monkeys from rectal infection. A cabotegravir implant that could offer longer-lasting protection than Apretude injections is also in the works.

Further back in the pipeline, broadly neutralizing antibodies, a type of immunotherapy, hold promise for both treatment and prevention (see sidebar below).

Ultimately, the longest HIV treatment would be a cure, and the longest PrEP would be a vaccine. Antiretroviral

therapy still has side effects, and chronic HIV infection can lead to health problems even for people with an undetectable viral load. What’s more, providing lifelong treatment or PrEP for millions of people worldwide is a daunting challenge.

But cure research is proceeding slowly, and the field has seen many disappointments. HIV vaccine research, too, has seen numerous failures, most recently the premature discontinuation of the large Mosaico trial after interim results showed that an experimental adenovirus vector HIV vaccine did not provide protection.

While researchers aren’t giving up on a cure or a vaccine, people living with or at risk for HIV can in the near term look forward to treatment and prevention options that can be taken less often, potentially making it easier to stay on therapy, keep the virus under control and achieve a better quality of life. But this promise must be available to everyone who could benefit.

“The fight to end HIV cannot be won with a ‘one-size fits all’ approach,” says Dázon Dixon Diallo, MPH, president of the women’s HIV and AIDS nonprofit SisterLove in Atlanta. “Like daily oral therapy, [long-acting therapy] won’t matter, and it won’t work, if people don’t know about it, have confidence in it or have access to it. Accessibility, acceptability and affordability all matter for those who need it most, especially people of African descent worldwide.” Q

before seven months postinfusion, while six of the seven who received the placebo did so. But again, this didn’t work for people whose virus was resistant to one or both of the antibodies. Other researchers found that more than 40% of children born with HIV who switched from oral antiretrovirals to infusions of two bnAbs (VRC01LS and 10-1074) administered every four weeks maintained an undetectable viral load for six months.

Long-acting antibodies are also being tested as a potential partner for Sunlenca. In a

small Phase I trial, 21 people with an undetectable viral load stopped oral antiretrovirals and received Sunlenca injections plus infusions of two bnAbs, teropavimab (a long-acting form of 3BNC117) and zinlirvimab (derived from 10-074). Participants were tested in advance to ensure that their HIV was susceptible to both antibodies. Six months later, 90% still had viral suppression. Next, a Phase II trial will assess whether viral suppression can be maintained when the regimen is administered semiannually for a longer duration.

“We’ve gone from asking patients to wake up every four hours to take zidovudine [AZT], to combination treatment with 15 to 20 pills a day, to now having the opportunity to give therapy every six months,” says lead investigator Joseph Eron, MD, of the University of North Carolina at Chapel Hill.

Antibodies

BY LAURA SCHMIDT

The Importance of Prioritizing Equity

Clinical trials o en lack diverse participants, skewing results and compounding health disparities in the groups of people le out of such studies. This is particularly true of HIV research trials, which primarily recruit young white men.

A native of Johannesburg, Chloe Orkin, MBBCH, MSc, is a professor of HIV medicine at Queen Mary University of London and the academic lead for equality, diversity and inclusion at Queen Mary’s School of Medicine and Dentistry.

Orkin is also the lead for HIV research at Barts Health National Health Service Trust in London, where she provides care for people living with HIV and runs a busy clinical trials unit.

What’s more, as director of the Sexual Health and HIV All East Research (SHARE) Collaborative, she investigates the inequalities associated with poor sexual health and HIV, especially among minority communities across east London.

“I want to make sure that equity is at the heart of everything that I do and that we try to change the narrative around what is an acceptable level of participation,” Orkin says. “That we don’t just accept that it’s impossible to recruit women or it’s impossible to recruit anybody that isn’t a young white man. That’s not true.”

Orkin began her early career training in South Africa, where she looked a er people living with HIV who lacked access to antiretrovirals, many of whom died. She also volunteered at an HIV hospice in Johannesburg, working primarily with people with severe opportunistic infections, before moving to the United Kingdom to continue her studies.

More recently, Orkin led an international study that showed that mpox (formerly monkeypox) can be very severe in people with advanced HIV.

As lead author of the First Long-Acting Injectable Regimen (FLAIR) study, Orkin, along with her colleagues, showed that monthly long-acting cabotegravir and rilpivirine injections are as e ective as standard daily oral HIV medications for people new to treatment. “Long-acting treatment is a huge focus of mine,” she says, “liberating people from the burden of daily treatment is important.”

Medical activism has consistently been at the center of Orkin’s career.

As a scienti c adviser for the Medicines Patent Pool, a public health organization, Orkin works to establish equitable access to new HIV drugs in countries where patients may not be able to pay market rates.

To ensure equity in HIV research she and fellow Queen Mary University researchers initiated a follow-up to the FLAIR study, the Implementing LongActing Novel Antiretrovirals (ILANA) study, which is already fully enrolled.

“We have developed an anti-racist, anti-sexist and anti-ageist protocol that makes sure we include people, because most of the studies that I have been part of, that have been set up by others, haven’t included very

many women,” she says. “Our study is going to be di erent.”

Outside of work, Orkin nds solace in playing with her three dogs and two cats and spending time with her partner of nearly 22 years. Orkin, who is Buddhist, also enjoys painting intricate mandalas, playing the ukulele, singing, and reading educational books on Buddhism, psychology and neuroscience and how the three subjects intersect.

Orkin emphasizes the importance of boosting diversity not only among trial participants but also among researchers. She notes that studies have shown that including women and people of color in research settings prompts “more interesting and nuanced” questions. “It’s about bystandership and trying to challenge existing narratives.” Q

Chloe Orkin upli s the HIV research community.

“We have developed an anti-racist, anti-sexist and anti-ageist protocol.”

If your test result is positive (reactive)

Today, it’s recommended that people living with HIV start treatment as soon as possible. Starting and staying on today’s treatment can help you get to and stay at an undetectable status and prevent transmission of HIV to others through sex. Here are some steps you can take for yourself and your sexual partner(s):

1 3 2

Talk to your healthcare provider

Ask what your test results mean for you and find out about HIV treatments that could best fit your personal routine.

Find out everything you can

The more you know about HIV, the better. You can discover resources by scanning the QR codes, or even find helpful information on your own.

Maintain your sexual health

Help l terms to know

TasP Treatment as Prevention

If you’re living with HIV, current research shows that taking HIV treatment as prescribed and getting to and staying undetectable prevents transmitting HIV to others through sex. This is also known as U=U (undetectable=untransmittable).

PrEP

Pre-Exposure Prophylaxis

Undetectable

A major goal of HIV treatment is getting your viral load to undetectable. Undetectable means that there is so little virus in the blood that a lab test can’t measure it. If you have questions about your lab results and what it means to be undetectable, talk with your healthcare provider.

PrEP (pre-exposure prophylaxis) means routinely taking prescription medicine before you’re exposed to HIV to help reduce your chances of getting it. There are di erent PrEP options available, some of which are 99% e ective. Just remember, PrEP doesn’t protect against other STIs, so be sure to use condoms and other healthy sex practices.

HEALTH, LIFE & HIV

ATRIPLA *

efavirenz + tenofovir disoproxil fumarate + emtricitabine

One tablet once a day. Each tablet contains 600 mg efavirenz + 300 mg tenofovir disoproxil fumarate + 200 mg emtricitabine. Take on an empty stomach. Dose should be taken at bedtime to minimize dizziness, drowsiness and impaired concentration.

BIKTARVY bictegravir + tenofovir alafenamide + emtricitabine

One tablet once a day. Each tablet contains 50 mg bictegravir + 25 mg tenofovir alafenamide + 200 mg emtricitabine. Take with or without food.

CABENUVA cabotegravir + rilpivirine

Complete Regimens

A long-acting injectable regimen administered as two intramuscular injections every four weeks or eight weeks. A one-month lead-in period with Vocabria (cabotegravir) + Edurant (rilpivirine) pills is optional. Take with food.

COMPLERA

rilpivirine + tenofovir disoproxil fumarate + emtricitabine

One tablet once a day. Each tablet contains 25 mg rilpivirine + 300 mg tenofovir disoproxil fumarate + 200 mg emtricitabine. Take with a meal.

DELSTRIGO

doravirine + tenofovir disoproxil fumarate + lamivudine

One tablet once a day. Each tablet contains 100 mg doravirine + 300 mg tenofovir disoproxil fumarate + 300 mg lamivudine. Take with or without food.

DOVATO dolutegravir + lamivudine

One tablet once a day. Each tablet contains 50 mg dolutegravir + 300 mg lamivudine. Take with or without food.

GENVOYA

elvitegravir + cobicistat + tenofovir alafenamide + emtricitabine

One tablet once a day. Each tablet contains 150 mg elvitegravir + 150 mg cobicistat + 10 mg tenofovir alafenamide + 200 mg emtricitabine. Take with food.

JULUCA

dolutegravir + rilpivirine

This quick-reference chart compares antiretroviral (ARV) options for the treatment of HIV, including adult dosing and dietary restrictions. Visit poz.com/drugchart for more info.

CIMDUO

tenofovir disoproxil fumarate + lamivudine

One tablet once a day. Each tablet contains 300 mg tenofovir disoproxil fumarate + 300 mg lamivudine. Take with or without food.

DESCOVY tenofovir alafenamide + emtricitabine

One tablet once a day. Each tablet contains 25 mg tenofovir alafenamide + 200 mg emtricitabine. Take with or without food.

Inhibitors (NRTIs, or nukes)

Nucleoside/Nucleotide Reverse Transcriptase

EMTRIVA * emtricitabine (also known as FTC)

One 200 mg capsule once a day. Take with or without food.

EPIVIR *

lamivudine (also known as 3TC)

One 300 mg tablet once a day, or one 150 mg tablet twice a day. Take with or without food. Also approved for the treatment of hepatitis B virus but at a lower dose. People living with both viruses should use the HIV dose.

EPZICOM * abacavir + lamivudine

One tablet once a day. Each tablet contains 600 mg abacavir + 300 mg lamivudine. Take with or without food. Should be used only by individuals who are HLA-B*5701 negative.

TEMIXYS

tenofovir disoproxil fumarate + lamivudine

One tablet once a day. Each tablet contains 300 mg tenofovir disoproxil fumarate + 300 mg lamivudine. Take with or without food.

TRUVADA * tenofovir disoproxil fumarate + emtricitabine

One tablet once a day. Each tablet contains 300 mg tenofovir disoproxil fumarate + 200 mg emtricitabine. Take with or without food.

VIREAD * tenofovir disoproxil fumarate

One 300 mg tablet once a day. Take with or without food.

ZIAGEN * abacavir

One 300 mg tablet twice a day, or two 300 mg tablets once a day. Take with or without food. Should be used only by individuals who are HLA-B*5701 negative.

EVOTAZ atazanavir + cobicistat

One tablet once a day. Each tablet contains 300 mg atazanavir + 150 mg cobicistat. Take with food.

KALETRA * lopinavir + ritonavir

Protease Inhibitors (PIs)

Two tablets twice a day, or four tablets once a day, depending on HIV drug resistance. Each tablet contains 200 mg lopinavir + 50 mg ritonavir. Take with or without food.

PREZCOBIX darunavir + cobicistat

One tablet once a day. Each tablet contains 800 mg darunavir + 150 mg cobicistat. Take with food.

PREZISTA darunavir

One 800 mg tablet or two 400 mg tablets plus one 100 mg Norvir tablet once a day, or one 600 mg tablet plus one 100 mg Norvir tablet twice a day, depending on drug resistance. Take with food.

REYATAZ * atazanavir

Two 200 mg capsules once a day, or one 300 mg capsule plus one 100 mg Norvir tablet once a day. Take with food.

ISENTRESS raltegravir

Two 600 mg Isentress HD tablets (shown) once a day for those who are treatment naive or whose virus has been suppressed on an initial regimen of Isentress. One 400 mg Isentress tablet twice daily for people with HIV treatment experience. Take with or without food.

Integrase Inhibitors

TIVICAY dolutegravir

One 50 mg tablet once a day for those rst starting ARV therapy or for those who have not used an integrase inhibitor in the past. One 50 mg tablet twice a day for people with treatment experience who have HIV that is resistant to other integrase inhibitors and when taken with certain ARVs. Take with or without food.

VOCABRIA cabotegravir

One 30 mg tablet taken once a day with once-daily Edurant for a month as an optional lead-in regimen before switching to Cabenuva injections or for short-term treatment. Take with food.

Complete Regimens

GENVOYA

elvitegravir + cobicistat + tenofovir alafenamide + emtricitabine

One tablet once a day. Each tablet contains 150 mg elvitegravir + 150 mg cobicistat + 10 mg tenofovir alafenamide + 200 mg emtricitabine. Take with food.

JULUCA

dolutegravir + rilpivirine

One tablet once a day. Each tablet contains 50 mg dolutegravir + 25 mg rilpivirine. Take with a meal.

ODEFSEY

rilpivirine + tenofovir alafenamide + emtricitabine

One tablet once a day. Each tablet contains 25 mg rilpivirine + 25 mg tenofovir alafenamide + 200 mg emtricitabine. Take with a meal.

STRIBILD elvitegravir + cobicistat + tenofovir disoproxil fumarate + emtricitabine

One tablet once a day. Each tablet contains 150 mg elvitegravir + 150 mg cobicistat + 300 mg tenofovir disoproxil fumarate + 200 mg emtricitabine. Take with food.

SYMFI AND SYMFI LO

efavirenz + tenofovir disoproxil fumarate + lamivudine

One tablet of either Sym or Sym Lo once a day. Each tablet of Sym contains 600 mg efavirenz + 300 mg tenofovir disoproxil fumarate + 300 mg lamivudine. Each tablet of Sym Lo (shown) contains 400 mg efavirenz + 300 mg tenofovir disoproxil fumarate + 300 mg lamivudine. Take on an empty stomach. Dose should be taken at bedtime to minimize dizziness, drowsiness and impaired concentration.

SYMTUZA darunavir + cobicistat + tenofovir alafenamide + emtricitabine

One tablet once a day. Each tablet contains 800 mg darunavir + 150 mg cobicistat + 10 mg tenofovir alafenamide + 200 mg emtricitabine. Take with food.

TRIUMEQ dolutegravir + abacavir + lamivudine

One tablet once a day. Each tablet contains 50 mg dolutegravir + 600 mg abacavir + 300 mg lamivudine. Take with or without food. Should be used only by individuals who are HLA-B*5701 negative.

VIREAD * tenofovir disoproxil fumarate

One 300 mg tablet once a day. Take with or without food.

ZIAGEN * abacavir

One 300 mg tablet twice a day, or two 300 mg tablets once a day. Take with or without food. Should be used only by individuals who are HLA-B*5701 negative.

Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs, or non-nukes)

EDURANT rilpivirine

One 25 mg tablet once a day. Take with food.

INTELENCE etravirine

One 200 mg tablet twice a day. Take with food.

PIFELTRO doravirine

One 100 mg tablet once a day. Take with or without food.

SUSTIVA * efavirenz

One 600 mg tablet (shown) once a day, or three 200 mg capsules once a day. Take on an empty stomach or with a low-fat snack. Dose should be taken at bedtime to minimize dizziness, drowsiness and impaired concentration.

RUKOBIA fostemsavir

One 600 mg tablet twice a day for people with HIV treatment experience. Take with or without food.

Inhibitors

Entry

SELZENTRY maraviroc

One 150 mg, 300 mg (shown) or 600 mg tablet twice a day, depending on other meds used, for people with HIV treatment experience. Take with or without food.

TROGARZO ibalizumab

A long-acting injectable administered intravenously as a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every two weeks for people with HIV treatment experience.

or for those who have not used an integrase inhibitor in the past. One 50 mg tablet twice a day for people with treatment experience who have HIV that is resistant to other integrase inhibitors and when taken with certain ARVs. Take with or without food.

VOCABRIA cabotegravir

One 30 mg tablet taken once a day with once-daily Edurant for a month as an optional lead-in regimen before switching to Cabenuva injections or for short-term treatment. Take with food.

NORVIR * ritonavir

PK Boosters

Norvir is usually taken to boost the levels of other ARVs in the blood. Take with food.

TYBOST cobicistat

One 150 mg tablet once a day in combination with ARVs that require boosting. Used only to boost other drugs. Take with food.

Capsid Inhibitors

SUNLENCA lenacapavir

Sunlenca tablets are taken as a loading dose, with injections once every six months therea er. Take with or without food.

These antiretroviral medications are rarely prescribed and no longer recommended:

APTIVUS tipranavir

COMBIVIR * zidovudine + lamivudine

CRIXIVAN indinavir INVIRASE saquinavir

FUZEON enfuvirtide

LEXIVA fosamprenavir

RETROVIR * zidovudine (AZT)

TRIZIVIR abacavir + zidovudine + lamivudine

VIRACEPT nelfinavir

VIRAMUNE nevirapine

ZERIT stavudine

result is positive (reactive)

result is positive (reactive)

with HIV start treatment as soon as possible. help you get to and stay at an undetectable others through sex. Here are some steps you can

with HIV start treatment as soon as possible. help you get to and stay at an undetectable others through sex. Here are some steps you can

3

everything can know about better. You can resources by QR codes, or helpful information own.

everything can know about better. You can resources by QR codes, or helpful information own.

Maintain your sexual health

Maintain your sexual health

Use condoms, practice safer sex, and start and stay on the treatment discussed with your healthcare provider.

Use condoms, practice safer sex, and start and stay on the treatment discussed with your healthcare provider.

terms to know

terms to know

Undetectable

Undetectable

A major goal of HIV treatment is getting your viral load to undetectable. Undetectable means that there is so little virus in the blood that a lab test can’t measure it. If you have questions about your lab results and what it means to be undetectable, talk with your healthcare provider.

A major goal of HIV treatment is getting your viral load to undetectable. Undetectable means that there is so little virus in the blood that a lab test can’t measure it. If you have questions about your lab results and what it means to be undetectable, talk with your healthcare provider.

taking prescription reduce your chances available, some of which protect against other sex practices.

taking prescription reduce your chances available, some of which protect against other sex practices.