2018 TREATMENT GUIDE
BECAUSE YOU’RE MORE THAN YOUR STATUS
THE CURIOUS CASE OF TV’S KARL SCHMID YES, COMING OUT POZ HAS MADE THIS ABC REPORTER EVEN HOTTER
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OUR 6TH ANNUAL HIV TREATMENT GUIDE
FOR 2018, PLUS HAS SHAKEN THINGS UP, FOCUSING OUR GUIDE ON THE INFORMATION YOU ARE MOST LIKELY LOOKING FOR. HERE ARE THE MOST COMMON MEDICATIONS APPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION FOR THE TREATMENT OF HIV AND OPPORTUNISTIC INFECTIONS.
Editor’s note: This info was culled from the National Institutes of Health’s drug database, the FDA, and individual pharmaceutical companies.
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RESEARCH BY JACOB ANDERSON-MINSHALL, TRUDY RING, DESIRÉE GUERRERO, DAVID ARTAVIA, AND MARY R. LADD
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Unless otherwise noted, all dosages are traditional adult dose.
ATRIPLA generic name: efavirenz, emtricitabine, and tenofovir disoproxil fumarate class of drug: single-tablet regimen maker: Gilead Sciences who is it for? For adults and children 12 years and older weighing at least 40 kg as an initial regimen. Should not be used for those with moderate or severe kidney or liver impairment, those with neuropsychiatric issues, or women who are pregnant or may become pregnant. traditional dosage One tablet once daily. Tablet contains 600 mg efavirenz (Sustiva, a NNRTI), 200 mg emtricitabine (Emtriva, a NRTI), and 300 mg tenofovir disoproxil fumarate (Viread, a NRTI).
BIKTARVY
NEW
generic name: bictegravir, emtricitabine, and tenofovir alafenamide class of drug: single-tablet regimen maker: Gilead Sciences who is it for? For adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (less than 50 copies per mL) on a stable antiretroviral regimen for at least three months with no history of treatment failure and no known resistance to the components of Biktarvy. Not recommended for those with creatinine clearance below 30 mL per minute, those with hepatitis B, or those with severe liver impairment. traditional dosage One tablet once daily. Tablet 38
includes 50 mg of bictegravir (an INSTI), 200 mg of emtricitabine (Emtriva, a NRTI), and 25 mg of tenofovir alafenamide (a NRTI). Doesn’t need to be taken with other HIV drugs.
COMPLERA
generic name: emtricitabine, rilpivirine, and tenofovir disoproxil fumarate class of drug: single-tablet regimen maker: Gilead Sciences who is it for? For those 12 and older who are new to antiretroviral drugs who have viral loads of 100,000 copies/ ml or less; or as a replacement regimen for individuals with a viral load of 50 copies/ml or less and no resistance to any components. Use caution if also positive for hepatitis B. traditional dosage One tablet once daily. Tablet includes 25 mg rilpivirine (Edurant, an NNRTI), 200 mg emtricitabine (Emtriva, a NRTI), and 300 mg tenofovir disoproxil fumarate (Viread, a NRTI).
EDURANT
EMTRIVA
generic name: emtricitabine class of drug: nucleoside reverse transcriptase inhibitor maker: Gilead Sciences who is it for? For adults and children as component of initial regimen. Dosing needs to be adjusted for those with decreased kidney function. Use caution if also positive for hepatitis B. traditional dosage One 200 mg capsule once daily.
EPIVIR
generic name: lamivudine or 3TC class of drug: nucleoside reverse transcriptase inhibitor maker: ViiV Healthcare who is it for? For adults and children at least 3 months old, as component of initial regimen. Dosing needs to be adjusted for those with decreased kidney function. traditional dosage One 300 mg tablet once daily, or one 150 mg tablet twice daily.
EPZICOM generic name: rilpivirine class of drug: nonnucleoside reverse transcriptase inhibitor maker: Janssen who is it for? For treatment of HIV-1 in adults and children 12 and older weighing at least 35 kg who haven’t previously taken antiretroviral drugs and have a viral load of 100,000 copies per milliliter of blood or less. traditional dosage One 25 mg tablet once daily with meal. It is always taken with other antiretrovirals, and is a component in single-tablet regimens Complera, Odefsey, and Juluca.
generic name: abacavir sulfate and lamivudine class of drug: nucleoside reverse transcriptase inhibitor maker: ViiV Healthcare who is it for? For adults and children weighing 25 kg or more as component of initial regimen. Not recommended for those with decreased kidney function. traditional dosage One tablet once daily. Tablet contains 600 mg abacavir sulfate and 300 mg lamivudine, both NRTIs.
EVOTAZ generic name: atazanavir and cobicistat class of drug: protease inhibitor and booster maker: Bristol-Myers Squibb who is it for? For those initiating treatment as a component of a regimen. Not recommended for those with liver impairment. Use with caution if you have heart or kidney problems; diabetes; hemophilia; or are pregnant, plan to become pregnant, or are using hormonal birth control. Do not breastfeed. traditional dosage One tablet once daily, in combination with other antiretroviral drugs. Tablet includs 300 mg atazanavir (Reyataz, a PI) and 150 mg cobicistat (Tybost, a PKE).
INTELENCE generic name: etravirine class of drug: nonnucleoside reverse transcriptase inhibitor maker: Janssen who is it for? For treatment-experienced HIV-1 patients with viral strains resistant to an NNRTI and other antiretroviral agents. For adults, children 6 years or older weighing at least 16 kg. traditional dosage One 200 mg tablet (or two 100 mg tablets) twice daily following meal. Pediatric patients (6-18 years old) should be dosed by medical professionals based on body weight.
ISENTRESS generic name: raltegravir class of drug: integrase inhibitor maker: Merck who is it for? For those
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new to treatment or treatment experienced, as a component of a regimen. For adults and children weighing at least 2 kg. Tell your doctor if you have tuberculosis, or liver problems or phenylketonuria. traditional dosage One 400 mg tablet twice daily for those with treatment experience. Those new to treatment or with undetectable viral loads may either take one 400 mg tablet twice daily or two 600 mg tablets once daily.
GENVOYA generic name: elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide class of drug: single-tablet regimen maker: Gilead Sciences who is it for? For those 12 or older who weigh at least 35 kg and are new to antiretroviral therapy; or as replacement therapy for those virologically suppressed for at least six months, with no previous virologic failure, and no drug resistance to the components of Genvoya. Not recommended if you have a creatinine clearance below 30 ml/minute. traditional dosage One tablet once daily. Tablet contains 150 mg of elvitegravir (an INSTI), 150 mg cobicistat (Tybost, a PKE), 200 mg emtricitabine (Emtriva, a NRTI), and 10 mg tenofovir alafenamide (a NRTI).
NORVIR generic name: ritonavir class of drug: protease inhibitor maker: AbbVie who is it for? Used only in combination with other antiretrovirals, recommended as component of initial
regimen for adults and children. Reduced dosage recommended for people taking other protease inhibitors. traditional dosage Six 100 mg tablets taken twice daily.
traditional dosage One tablet once daily with food. Tablet contains 800 mg of darunavir (Prezista, a PI) and 150 mg of cobicistat (Tybost, a boosting agent).
PREZISTA
ODEFSEY generic name: emtricitabine, rilpivirine, and tenofovir alafenamide class of drug: single-tablet regimen maker: Gilead Sciences who is it for? For adults and children 12 years and older weighing at least 35 kg who are new to antiretroviral drugs, who have a viral load of 100,000 copies/ml or less; or can be used as a replacement regimen for individuals with a viral load of 50 copies/ ml or less, who have been virologically-suppressed for at least six months. traditional dosage One tablet once daily. Tablet conains 200 mg of emtricitabine (Emtriva, a NRTI), 25 mg of rilpivirine (Edurant, a NNRTI), and 25 mg of tenofovir alafenamide (a NRTI).
PREZCOBIX generic name: darunavir and cobicistat class of drug: protease inhibitor and a boosting agent maker: Janssen who is it for? For both treatment naive and treatment-experienced adults with no darunavir-related resistance. Should be used in combination with other antiretroviral medicines. Use with caution if you have liver or kidney problems; or if you are pregnant, breastfeeding, or plan to become pregnant.
generic name: darunavir class of drug: protease inhibitor maker: Janssen who is it for? For treatment of HIV-1 both those initiating treatment and those who have previously been on antiretroviral therapy, including those with some drug resistance to PIs. For adults and children 3 years or older weighing at least 10 kg. May reduce effectiveness of birth control pills. traditional dosage One 800 mg tablet once daily with 100 mg Norvir or 150 mg Tybost for those without resistance. One 600 mg tablet with 100 mg Norvir taken twice daily for pregnant women and those with Prezista-related resistance. Must be taken with a booster like Norvir or Tybost. Pediatric patients (3 years to less than 18 years old and weighing at least 10 kg) should be dosed by a medical professional based on body weight. Should always be taken with food.
REYATAZ generic name: atazanavir class of drug: protease inhibitor maker: Bristol-Myers Squibb who is it for? For both treatment naive and treatment-experienced individuals. traditional dosage 300 mg capsule, taken with 100 mg of Norvir or 150 mg Tybost, once daily.
SELZENTRY generic name: maraviroc class of drug: entry inhibitor maker: ViiV Healthcare who is it for? Not recommended as a component of an initial regimen. For the treatment of only CCR5-tropic HIV-1 infection in adults and children 2 years or older, weighing at least 10 kg, and having a creatinine clearance of at least 30mL/minute.Tell your doctor if you have heart or kidney problems, or if you have low blood pressure or take medication to lower it. traditional dosage 300 mg twice daily; or 150 mg twice daily if taken with CYP3A inhibitors; or 600 mg twice daily if taken with CYP3A inducers.
STRIBILD generic name: elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate class of drug: single-tablet regimen maker: Gilead Sciences who is it for? For those 12 or older, who weigh at least 35 kg, and are new to antiretroviral therapy; or as a replacment regimen for those virologically suppressed on their current regimen for at least six months, who have no previous virologic failures, and no drug resistance to Stribild components. Not recommended for those with a creatinine clearance below 70 ml/minute or for those with severe liver problems, or during pregnancy. traditional dosage One tablet once daily. Tablet contains 150 mg of elvitegravir (a INSTI), 150 mg cobicistat (Tybost, a PKE), 200 mg emtricitabine (Emtriva, a NRTI), and 300 mg tenofovir HIVPLUSMAG.COM
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SUSTIVA generic name: efavirenz class of drug: nonnucleoside reverse transcriptase inhibitor maker: Bristol-Myers Squibb who is it for? For adults and children 3 months and older weighing at least 3.5 kg as a component of initial regimen. Tell your doctor if you have had hepatitis or other liver problems, mental illness, or seizures. traditional dosage One tablet of 600 mg once daily. It is a component in the single-tablet regimen Atripla.
TIVICAY generic name: dolutegravir class of drug: integrase inhibitor maker: GlaxoSmithKline who is it for? For both those new to treatment and those who have taken integrase inhibitors previously and may have resistance to such drugs. For adults and children at least 30 kg. Take during pregnancy only if potential benefits outweigh risk. traditional dosage One 50 mg tablet, once daily for those new to antiretrovirals; twice daily for those who take certain other antiretrovirals or have taken integrase inhibitors and may have resistance.
TRIUMEQ generic name: abacavir sulfate, dolutegravir, and lamivudine 40
class of drug: singletablet regimen maker: ViiV Healthcare who is it for? For adults and children weighing at least 40 kg as initial regimen. Not recommended for those with a creatinine clearance below 50 ml/minute or those with liver impairment. traditional dosage One tablet once daily. Tablet contains 600 mg abacavir sulfate (Ziagen, a NRTI), 50 mg dolutegravir (Tivicay, an INSTI), and 300 mg lamivudine (Epivir, a NRTI).
TROGARZO
NEW
generic name: ibalizumab class of drug: postattachment inhibitor maker: Theratechnologies who is it for? For heavily treatment-experienced adults with multidrug resistant HIV-1 infection who are failing their current antiretroviral regimen, as a component of a regimen. traditional dosage A loading dose of 2,000 mg, administered as an injection, followed by a maintenance dose of 800 mg every two weeks.
TRUVADA generic name: emtricitabine and tenofovir disoproxil fumarate class of drug: nucleoside reverse transcriptase inhibitor maker: Gilead Sciences who is it for? For those with HIV or at high risk of becoming HIV-positive. As treatment for HIV, for adults and children weighing at least 17 kg. As HIV prevention, for adults and and adolescents 15 or older weighing at least 35 kg. Dosing adjustments necessary for those with
decreased kidney function. for hiv treatment: One tablet once daily, in combination with other HIV medications. Tablet includes 200 mg emtricitabine (a NTRI) and 300 mg tenofovir disoproxil fumarat (a NRTI). for hiv prevention: One tablet once daily. Must be paired with regular HIV tests and safer sex practices.
VIREAD generic name: tenofovir disoproxil fumarate class of drug: nucleoside reverse transcriptase inhibitor maker: Gilead Sciences who is it for? For adults and children at least 2 years old and weighing at least 10 kg, used in combination with other antivirals to treat HIV-1 infection. Dosage adjustments recommended for those with kidney problems. traditional dosage One 300 mg tablet once daily.
ZIAGEN generic name: abacavir maker: GlaxoSmithKline who is it for? For adults and children at least 3 months old, as a component of initial regimen. Dosage adjustments not needed for those with kidney problems. traditional dosage One 300 mg twice daily or two 300 mg once daily. Individuals with mild liver impairment should take 200 mg twice daily.
MEDS 101 DRUG CLASSES COMBAT HIV IN DIFFERENT WAYS. HERE’S HOW.
Drugs that treat HIV, known as antiretroviral medications, are grouped in various classes based on the methods the drug uses to attack the virus. HIV treatment regimens include drugs from multiple classes, to improve their combined effectiveness and help prevent the development of drug resistance. Here are brief descriptions of the classes and how they work. ENTRY AND FUSION INHIBITORS (EIs) Drugs in this class help block HIV from binding, fusing, and entering T cells. They are always taken with other HIV medications. INTEGRASE STRAND TRANSFER INHIBITORS (INSTIs) Drugs in this class block integrase, an enzyme HIV needs in order to reproduce. HIV uses integrase to insert its viral DNA into the DNA of T cells. Blocking the
SHUTTERSTOCK
disoproxil fumarate (Viread, a NRTI).
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integration process prevents HIV from replicating. They are always taken with other HIV medications. NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS (NRTIs, also known as nukes) Drugs in this class block reverse transcriptase, an enzyme that HIV needs in order to reproduce. HIV uses reverse transcriptase to convert its RNA into DNA, blocking the reverse transcription process prevents HIV from replicating. They are always taken with other HIV medications. NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS (NNRTIs, also known as non-nukes) Drugs in this class also block reverse transcriptase, as NRTIs do, but in a different way. They are always taken with other HIV medications. PHARMACOKINETIC ENHANCER/ CYP3A INHIBITORS (PKEs, also known as boosters) Drugs in this class boost the effectiveness of another antiretroviral medication. When the two are taken together, the pharmacokinetic enhancer slows the breakdown of the other drug, which allows the drug to remain in the body longer at a higher concentration. They are always taken with other HIV medications. POST-ATTACHMENT INHIBITORS (PAIs) Drugs in this class bind to CD4 cells after HIV has attached to them, but still inhibit the HIV virus from successfully infecting those cells. They are always taken with other HIV medications.
SHUTTERSTOCK
PROTEASE INHIBITORS (PIs) Drugs in this class block activation of protease, an enzyme HIV needs to develop. Blocking protease prevents immature forms of HIV from becoming a mature virus capable of infecting other T cells. They are always taken with other HIV medications. SINGLE-TABLET REGIMENS (STRs) These are fixed-dose pills that combine multiple anti-HIV medications (often three or more) from more than one class of drug into a single tablet, which is usually taken just once a day. They do not need to be taken with other HIV medications.
SOME OTHER DRUGS YOU NEED TO KNOW
THESE TREAT HIVRELATED CONDITIONS. ANDROGEL, FORTESTA, TESTIM
generic name: testosterone gel makers: AbbVie, Endo Pharmaceuticals cautions: For men’s use only. Women and children should avoid skin-to-skin contact with application area. Tell your doctor about all your health conditions, especially if you have breast or prostate cancer; difficulty in urination due to enlarged prostate; heart, kidney, or liver problems; or sleep apnea.
traditional dosage Amount and frequency determined by physician. Applied topically. what it treats Treats low testosterone, which can be a complication of HIV, especially for men over 50.
EGRIFTA
generic name: tesamorelin maker: Theratechnologies cautions: Do not take if you have or had pituitary gland issues, if you have active cancer, or if you are pregnant or breastfeeding. traditional dosage 2 mg injected subcutaneously (just below the skin), once daily. what it treats Reduces HIV-related excess belly fat by encouraging the body to produce natural growth hormones.
ERAXIS
generic name: anidulafungin maker: Pfizer cautions: Effects on women who are pregnant or breastfeeding have not been studied, discuss possibility of pregnancy with your doctor.
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traditional dosage For esophageal candidiasis 100 mg by injection the first day, followed by 50 mg daily dose thereafter for 14 days; for candidemia and Candida infections, 200 mg by injection first day, followed by 100 mg daily. what it treats Treats esophageal candidiasis, candidemia, and other Candida infections.
CAN’T AFFORD YOUR MEDS? HELP IS ON THE WAY BY DAVID ARTAVIA If you find yourself struggling to make ends meet, finding affordable HIV treatment may seem nearly impossible. But the AIDS Drug Assistance Program (ADAP) provides financial assistance to nearly half a million people in the U.S. who aren’t able to afford their meds. Now, with the ADAP Directory online, finding help has never been easier. ADAP.Directory (yes, that’s the actual website) is a one-stop online resource for the latest info, linking HIVpositive people to treatment assistance programs within their state fitting their needs. While the ADAP program is federally funded, the directory is made possible by grants from Walgreens and pharma companies, including AbbVie, Gilead Sciences, Janssen Therapeutics, Merck & Co., and ViiV Healthcare. Each state has its own Maximum Qualifying Income, which is the most you can make and still qualify for ADAP. Some states start at the poverty level (around $12,000 a year—plus $4,200 for each additional family member). But, in higher income states that number goes way up. (in California, for example, you can make over $60,000 and still qualify for assistance.) To find out if you qualify, visit ADAP.Directory/About and fill in the ADAP Income Eligibility Calculator. 42
MARINOL
generic name: dronabinol maker: AbbVie cautions: Do not use if you have a psychiatric history, are pregnant or may become pregnant. Use caution if you experience seizures or have a cardiac disorder. traditional dosage One 2.5 mg capsule taken twice daily. what it treats A man-made form of cannabis, it is used to stimulate the appetite of people living with HIV.
MEGACE ES, MEGACE ORAL SUSPENSION
generic name: megestrol acetate maker: Strativa, Bristol-Myers Squibb cautions: Do not use if you are pregnant. If you have a history of blood clots, check with your doctor before taking. traditional dosage 625 mg (one teaspoon), once daily. what it treats Treats appetite loss, severe malnutrition, or unexplained, significant weight loss.
(lipoatrophy) and stimulates the body’s collagen production to combat HIV-related facial wasting.
SCULPTRA
generic name: injectable poly-L-lactic acid maker: Dermik Laboratories who is it for? If you have an active skin infection or inflammation in or near the treatment area, do not use until this condition is under control. traditional dosage Amount and frequency varies by patient; delivered by subcutaneous injection. what it treats Helps restore or correct signs of facial fat loss (lipoatrophy).
SEROSTIM
generic name: somatropin maker: EMD Serono cautions: Do not use if you are critically ill, following surgery, have serious injuries, or a severe breathing problem, or have cancer. Do not use if you have eye problems caused by diabetes. traditional dosage 0.1 mg per kg of body weight daily (up to 6 mg), injected subcutaneously at bedtime. what it treats Treats wasting (HIVrelated weight loss).
SPORANOX
generic name: crofelemer maker: Napo cautions: Get tested to make sure your diarrhea is not caused by an infection. traditional dosage One 125 mg delayed-release tablet, twice daily. what it treats Formerly named Fulyzaq. Relieves HIVrelated diarrhea that is a side effect of many antiretroviral drugs
generic name: itraconazole maker: Janssen cautions: Use caution if you have heart, lung, or kidney disease, or take certain antiretrovirals. Do not take capsules if you have or had congestive heart failure. traditional dosage 200 mg daily, in oral solution, without food (if possible) for 1 to 2 weeks for oral candidiasis; 200 mg daily in capsule form, for other fungal infections. what it treats Treats fungal infections. The oral solution only treats the fungal infections of oral candidiasis (thrush) and esophageal candidiasis. Sporanox capsules are a different preperation than Sporanox Oral Solution and should not be used interchangeably.
RADIESSE
VFEND
MYTESI
generic name: calcium hydroxylapatite maker: Merz Aesthetics cautions: Users of blood thinners or aspirin may have bleeding or bruising at the injection site. traditional dosage Single-use vial injected into the skin. what it treats Treats facial fat loss
generic name: voriconazole maker: Pfizer cautions: Use with caution if you have a heart arrhythmia. traditional dosage 200 mg in tablets or oral solution, every 12 hours. what it treats Treats fungal infections, such as esophageal candidiasis.
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THE NEWEST KIDS ON THE BLOCK
THE RUN DOWN ON THE LATEST FDA-APPROVED HIV MEDS. BY PLUS EDITORS
SHUTTERSTOCK (ILLUSTRATION) JOSHUA COLEMAN ON UNSPLASH (PILL BOTTLES)
BIKTARVY
CERTAINLY ONE OF the most exciting advances in HIV treatment this year is the U.S. Food and Drug Administration’s approval of the once-daily, singletablet regimen, Biktarvy. The drug demonstrated high efficacy, few drug interactions, and a high barrier to resistance in extensive clinical trials. In April, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended the new treatment be granted authorization for marketing in Europe. If approved, Biktarvy will be available in all 28 countries of the European Union, Norway, Iceland, and Liechtenstein. The smallest single-pill, INSTI-based triple therapy regimen available on the market, Biktarvy combines the novel, unboosted integrase strand transfer inhibitor (INSTI) bictegravir with a backbone of Descovy (emtricitabine and tenofovir alafenamide), Gilead’s dual nucleoside reverse transcriptase inhibitor (NRTIs). “In clinical trials through 48 weeks, no patients taking the regimen of bictegravir plus FTC/TAF developed treatment-emergent resistance, results that were observed both in people new to therapy and those who were virologically suppressed and chose to switch regimens,” said Paul Sax, MD, professor of medicine at Harvard Medical School and a lead clinical trial investigator. “In addition, the clinical data show that the regimen’s antiviral efficacy, tolerability profile, and limited drug interactions offer an effective new treatment option for a range of people living with HIV.” Biktarvy is a complete regimen for the treatment of HIV in adults who have either never been on antiretroviral treatment, or who are virally suppressed
and looking to simplify or replace their current regimen. You should only switch to Biktarvy if you have been on a stable antiretroviral regimen for at least three months with no history of treatment failure and no known resistance issues associated with its individual components. Since Biktarvy does not contain the drug abacavir, it does not require an HLA-B*5701 test (which checks for a hypersensitivity to abacavir), has no food intake requirements, and has no baseline viral load or CD4 count restrictions. As long as your kidneys are functioning healthily (your estimated creatinine clearance must be greater than or equal to 30 mL/ minute), no dosage adjustment is required. According to Biktarvy’s prescribing information, healthcare providers should test for hepatitis B and renal function prior to initiating treatment, and appropriately monitor renal function during therapy. Throughout the clinical trials, none of the participants developed virologic resistance or discontinued Biktarvy due to adverse renal events. The most common side effects were diarrhea, nausea, and headache. “Gilead is committed to improving care and simplifying therapy for people living with HIV,” said John F. Milligan, PhD, Gilead’s president and CEO. “We are pleased to offer Biktarvy, our latest triple-therapy treatment, which brings together the potency of an integrase inhibitor with the most-prescribed dual-NRTI backbone in a once-daily single-tablet regimen.” Additional clinical trials of Biktarvy are ongoing, including new studies dedicated to women, adolescents, and children living with HIV—which Gilead plans to present data from at future scientific conferences. HIVPLUSMAG.COM
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JULUCA
IN THE EARLY days of the epidemic, the first treatment options for HIV were so harsh on the body (due to high levels of toxicity) that the side effects were nearly worse than the immune system damage of the virus itself. Fortunately, since breakthroughs made with antiretroviral therapy in the 1990s, researchers have remained dedicated to developing treatment regimens that require less medication and fewer pills, and offer lower toxicity. Now, ViiV Healthcare has created Juluca, the first single-pill, two-drug regimen. “Juluca, our new two-drug regimen, once-daily, single pill, now provides people living with HIV who are virologically suppressed the option to reduce the number of antiretrovirals they take, while maintaining the efficacy of a traditional three-drug regimen,” John C. Pottage, Jr., MD, the chief scientific and medical officer at ViiV Healthcare, told reporters in November 2017, when Juluca was FDA-approved. Pottage said the new regimen was developed “based on the fundamental principle that no one should have to take more medicines than necessary.” To use Juluca—the first two-drug regimen comprising the integrase strand transfer inhibitor, dolutegravir (a product of ViiV Healthcare), and the non-nucleoside reverse transcriptase inhibitor, rilpivirine (developed by Janssen Therapeutics)—you must already be virologically suppressed. According to a statement by ViiV Healthcare, the FDA-approved Juluca can be used “as a complete regimen for the maintenance treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral (ART) regimen for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.” In clinical trials, very few side effects were reported. The main serious adverse reactions to Juluca are severe skin rash, depression, and liver problems. You should contact your health care provider right away if you develop a skin rash or major changes in mood (feelings of sadness or hopelessness, lack of motivation). People with a history of hepatitis B or C, or who have elevated results on liver function tests, may have an increased risk of developing new or worsening liver problems while taking Juluca. Liver problems have also occurred in people taking it who have no history of liver problems. Depending on your specific health history, your doctor may want to test your liver function before starting Juluca, and may continue to monitor it while on treatment. Deborah Waterhouse, ViiV Healthcare’s CEO, told reporters, “The FDA approval of Juluca marks an important milestone in our commitment to deliver innovative advances in HIV care by providing new treatment options that challenge the traditional approach to care. This is the start of a new era in HIV treatment. We are delighted to be able to provide the first two-drug regimen to physicians and people living with HIV in the U.S., to support the reduction of longterm ART exposure as they receive life-long treatment for their chronic condition.” ViiV Healthcare is also exploring the potential of other two-drug therapies (both in phase 3 44
development), a once-daily, single pill containing dolutegravir/lamivudine for treatment-naïve patients, as well as a cabotegravir/rilpivirine long-acting injectable for treatment-experienced and naïve patients. Thanks to ViiV Healthcare and other drug developers focused on simplified treatment options, the quality of life continues to improve for those living with HIV.
CIMDUO
CIMDUO IS A once-daily combination of two nucleoside reverse transcriptase inhibitors—lamivudine and tenofovir disoproxil fumarate—and is indicated in combination for the treatment of HIV in adults and children weighing at least 35 kg. Cimduo is not a complete treatment regimen and is meant to be prescribed with other antiretroviral agents to complete therapy. It was developed to simplify treatment for those who are taking these two meds with the option of combining them into a single pill, which essentially allows many folks to drop from a three-pill to twopill regimen—and fewer pills usually translates to greater adherence. Like most HIV medicines, Cimduo may cause some bothersome but manageable side effects, such as nausea or occasional dizziness. More serious adverse reactions that can be caused by Cimduo include a buildup of lactic acid in the blood (lactic acidosis), severe liver problems, and new or worse kidney problems. If you have both HIV and hepatitis B and take Cimduo, your HBV infection may flare up if you stop taking Cimduo. To help avoid this, take Cimduo exactly as prescribed and don’t stop taking it without talking to your doctor first. A worsening of liver disease has occurred in people being treated for hepatitis C and taking HIV medicines and interferon alfa (with or without ribavirin). If you are taking Cimduo and interferon alfa, and you have any new symptoms, tell your health care provider right away. Others taking Cimduo also have developed new or worse kidney problems, including kidney failure. Your health care provider may do blood and urine tests to check your kidneys before and during treatment with Cimduo. “Mylan has been on the forefront of bringing innovative delivery and dosage forms of ARVs to millions of patients in the developing world,” said Mylan president, Rajiv Malik. “We’ve already extended our reach to people in the U.S. living with HIV with the introduction of Symfi Lo and Cimduo.” The company also added Symfi and Symfi Lo to their portfolio of FDAapproved drugs (see below). Mylan is the world’s largest supplier by volume of HIV therapies—more than 40 percent of the 20 million people on treatment worldwide depend on a Mylan product.
SYMFI AND SYMFI LO
THIS SPRING , GLOBAL pharmaceutical company Mylan announced that the FDA approved their new single-tablet, once-daily regimens Symfi, and Symfi Lo. Symfi contains three different medicines combined into one pill that is a complete regimen: the non-nucleoside reverse transcriptase inhibitor, efavirenz; and two nucleoside reverse transcriptase inhibitors, lamivudine and tenofovir disoproxil fumarate.
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Symfi and Symfi Lo both include this same triple combination of molecules—the only difference being that Symfi Lo features a reduced dose of efavirenz, while Symfi uses a dosing similar to other efavirenz products already on the market. The combination represented by Symfi is the most widely taken antiretroviral regimen outside the United States, with more than seven million users worldwide in 2016, according to Mylan. Symfi is indicated as a complete regimen for the treatment of HIV in adults and children weighing at least 40 kg. Not many side effects were reported, though some adverse reactions can be very serious. Though not specifically related to Symfi use, lactic acidosis and hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside combos that include lamivudine and tenofovir disoproxil fumarate. Some people with hepatitis B also reported severe acute exacerbations of the condition, and had to discontinue regimens with these components. “As the largest supplier of antiretrovirals by volume in the world, Mylan has a longstanding commitment to expanding affordable access to treatments for people living with HIV,” said Mylan’s chief executive officer, Heather Bresch. “As we continue to grow our U.S. portfolio of ARV products, now including Symfi Lo, Symfi, and Cimduo, we are providing access to patients and empowering them to choose the lower-cost ARV treatment option that is right for them.”
HELLO, HOT SHOT MULTIDRUG-RESISTANT HIV ISN’T A DEATH SENTENCE ANYMORE.
BY BENJAMIN M. ADAMS AND JACOB ANDERSON-MINSHALL
he U.S. Food and Drug Administration has approved a years-indevelopment, first-of-its-kind treatment that could be a lifesaver for those resistant to most or all available HIV meds. The long-acting injectable ibalizumab (brand name Trogarzo) is the first non-oral therapy of its kind, and one specifically aimed at fighting multi-drug resistant strains of HIV. Ibalizumab concluded its phase 3 trials over a year ago, and since then researchers have recruited participants for an expanded access study that gives needy patients (who didn’t qualify for the CONTINUED ON PAGE 51
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ON THE HORIZON
THESE INVESTIGATIONAL HIV DRUGS ARE EITHER EXPECTING FDA APPROVAL OR ARE CURRENTLY IN LATE STAGE TRIALS. REMEMBER THEIR NAMES. BY DAVID ARTAVIA
There are always new drugs being investigated in clinical trials around the globe, or awaiting FDA approval. Here are the most promising:
COMING IN 2018
DORAVIRINE/TENOFOVIR DF/LAMIVUDINE (BRAND NAME TO BE DETERMINED): Expected to be FDA-approved this October, DOR/ TDF/3TC is a single-tablet regimen with a non-nucleoside reverse transcriptase inhibitor, which can benefit those who have developed resistance to other non-nukes. FOSTEMSAVIR (NAME TBD): ViiV Healthcare’s latest drug is expected be FDA-approved this year following a successful phase 3 trial. A gp120 attachment inhibitor, fostemsavir works by attaching to the gp120 protein on the outer surface of HIV, blocking the virus from getting into and corrupting immune cells. SYMTUZA (DARUNAVIR/COBICISTAT/EMTRICITABINE/TENOFOVIR ALAFENAMIDE): This single-tablet regime was approved for use in Europe last September, and is expected to be approved by the FDA this summer. Developed by Janssen Inc., DRV/COBI/FTC/TAF would be the first single-tablet regimen containing a protease inhibitor. Single tablets could mean a lesser chance of missing doses.
COMING IN 2019
CABOTEGRAVIR/RILPIVIRINE LONG-ACTING INJECTABLE (NAME TBD): Consisting of ViiV Healthcare’s integrase inhibitor cabotegravir and Janssen’s NNRTI rilpivirine, this long-acting injectable is administered once every four to eight weeks. During trials, 90 percent of participants remained undetectable during 96 weeks of studies. It’s expected to be FDA-approved sometime in 2019. DOLUTEGRAVIR/LAMIVUDINE (NAME TBD): Earlier this year, ViiV Healthcare began a phase 3 study (TANGO) to see if folks on a three-drug regimen can maintain viral suppression upon switching to this two-drug therapy, DTG/3TC. The two-drug combo is expected to be approved in 2019.
2020 AND BEYOND:
VACCINES: Although no HIV vaccines exist yet, researchers are studying investigational preventive vaccines and treatment vaccines. Therapeutic vaccines are designed to slow the progression of HIV and to delay the onset of stage 3 HIV, or AIDS. Research is well underway and from the looks of it, we’re likely to see more advancement with these: VAC-3S: Currently in phase 2a trial, VAC-3S is made up of an HIV peptide (a piece of HIV protein), used to help the body generate an immune response against HIV. The goal is for VAC-3S to slow down the progression of HIV and to eliminate the need for ART while still remaining undetectable. Researchers hope it will help eliminate all HIV from the body as part of a combination strategy.
VRC DNA-HIV: Currently in phase 2 development, VRC DNA-HIV is a DNA vaccine made up of parts of HIV’s genetic information, which is meant to produce an immune response against HIV in the body. It may also act as an HIV prevention tool. When combined with other vaccines, it may reduce the amount of inactive HIV in the body. VRC RAD5: Currently in phase 2 development, VRC rAd5 is a viral vector vaccine, which means it delivers pieces of HIV’s genetic blueprint into the body’s cells. From there, the body uses the genetic information to produce a response from the immune system that can fight the virus. VRC rAd5 may also act as an HIV prevention tool, though its main focus right now is as a therapeutic vaccine. LATENCY-REVERSING AGENTS: The goal of latency-reversing agents is to reactivate latent HIV hiding within resting T cells so that their home cell can be killed off by the body’s immune system. This remains one of the main obstacles to curing HIV, given that the virus can remain inactive inside certain cells (referred to as HIV reservoirs) for many months or even years. DISULFIRAM: Currently FDA-approved for helping in the management of alcoholism, Disulfiram is now in phase 1/2 development as a latency-reversing agent for HIV as a type of agent called a phosphatase and tensin homolog (PTEN) inhibitor. Its involvement is in the regulation of the cell cycle, preventing cells from growing and dividing too rapidly. It’s also a target of many cancer drugs. LEFITOLIMOD: Currently in phase 1b/2a development as an HIV therapeutic, lefitolimod is a type of latency-reversing agent called a toll-like receptor agonist. Researchers believe it may also improve the body’s immune response to HIV in addition to its effectiveness on latent virus cells. Researchers in Denmark put lefitolimod to test in the TEACH study, which showed it to be safe in early phase trials. CD4 ATTACHMENT INHIBITOR: CD4 attachment inhibitors work by attaching to a protein on the surface of the immune cells. As a result, it keeps HIV from attaching and entering the healthy cell. This prevents HIV from multiplying and can reduce the amount of HIV in the body. UB-421: Currently entering a phase 3 clinical trial, UB-421 saw safety and effectiveness in lowering one’s viral load in phase 2 and phase 2a trials in Taiwan sponsored by United Biomedical. HIVPLUSMAG.COM
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THAT’S NOT CRAZY TALK
WHETHER YOU BRING UP THE TOPIC OF ANTIDEPRESSANTS OR ANTIANXIETY MEDICATION—OR YOUR DOCTOR DOES—IT CAN BE THE START OF AN AWKWARD CONVERSATION. HERE’S HELP.
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BY GARY MCCLAIN, PHD,
of my therapy clients have been prescribed medication for depression or anxiety by their primary care physicians. Some of them initiated these discussions with physicians following a conversation we had about trying medication. Others have had this discussion with their doctors before finding their way to me. Still other clients have told me their doctor suggested they consider medication after they’ve received a medical diagnosis—including learning they are HIV-positive—that their doctor worried would impact them emotionally. I always appreciate when physicians have concern for the emotional states of their patients, but I also hear from clients that conversations with their primary care physicians about depression or anxiety medication are rarely easy. People don’t always know how to bring up mental health issues with their doctor. Or they may have concerns about what they should know before consenting to begin medication. I like to present the discussion about such medications as an opportunity for clients to team up with their doctors in their health care. Here are some guidelines to help you have this conversation: If you are requesting the medication, be direct and specific. Let your doctor know that you are concerned about your mental health and why. Say something like, “I think I may be experiencing depression. Over the last (be specific about the timeframe), I have been feeling (briefly list your symptoms).” If you have talked this over with a therapist, make sure your doctor is aware of that as well. If your doctor recommends medication, ask them to be specific about what they are recommending and why. Alternately, your doctor may initiate the conversation, by asking you some questions about your mental health, and then suggesting medication. If so, ask them to explain what they heard you say, or what they observed, that led them to diagnose you with depression or anxiety and why they recommend a pharmaceutical solution. HIVPLUSMAG.COM
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Ask why a specific drug is being recommended. Your physician may have specific reasons why one medication is being recommended over another. Or the medication being recommended may be your physician’s standard “go to,” which they generally recommends for patients who have symptoms similar to yours. If you have questions about how well it’s working, later on, or want to talk about it with another physician, this will be important information. And ask if there are other options. Not only other medications, but also therapy. Get fully informed on your physician’s thinking behind their recommendation. You may want to research some of these alternatives on your own to help you to make the medication decision. Asking these
you’re at it, also ask if there any side effects that, if experienced, should be reported immediately, or that might be dangerous. Keep in mind that individuals vary in terms of whether they experience side effects and how pronounced those side effects are. Getting clear with your doctor on potential side effects—both common and rare—will help to set your expectations for how you might be impacted. This will help you decide if this is the right path for you. Don’t start until you are ready. The decision to go on medication for depression or anxiety is a big one. You may not be ready to give the go ahead after a brief discussion with your doctor. You may want to say something like, “I need some time to digest all of this, and do some of my own research. I will get back to you soon.”
questions will also help you to feel confident about your physician’s level of experience in treating depression or anxiety. Understand how the medication should benefit you, and how soon. I often hear from my clients that they have no idea how their medication should make them feel, if they should feel better, or just not feel worse. Some people do notice a shift in their mood as a result of medication. Or, your medication may put a “floor” under your depression, so you don’t sink any lower, or a “ceiling” over your anxiety so you don’t experience anxious episodes or panic. Ask your physician to let you know what you should expect in terms of any symptom relief or prevention. And ask how soon you should expect to experience the benefits. This will help you to determine if the medication is helping or not. Ask your doctor if they can give you a sense of how long they think you might need the medication. Is this to help get you through a rough spot or something you might have to take indefinitely? It’s also important to get an idea of potential side effects of any medication your doctor recommends. Some medications have quite pronounced side effects, such as weight gain or changes in libido, while others have relatively few side effects. So ask your doctor to give you an idea of what you might expect. While 50
And then do your own due diligence by researching the recommendation and your options. You may then want to schedule another appointment to talk about what you learned. Consider a second opinion from a psychiatrist. Many primary care physicians have been prescribing psychiatric medications for years, and are very competent. But still, consider this: If you had a serious skin condition, you would probably want to consult with a dermatologist. If you had eye trouble, you would probably go to an ophthalmologist. So if you are experiencing depression or anxiety or another mental health issue that may require medication, you might also want to seek the opinion of a psychiatrist. I specifically recommend seeing a psychiatrist in this context rather than a psychologist, counselor, or other mental health professional because only psychiatrists can prescribe medication. Don’t hesitate to be high maintenance. Keep your doctor abreast of how you’re feeling. Raise any concerns you have about how the medication may, or may not, be affecting you. Your doctor can’t help you if you don’t keep them in the loop. To reiterate: Ask questions. Express your concerns. Do your own research. That way, if you take the big step of starting medication, you’ll do it with confidence!
Gary McClain, PhD, is a therapist, patient advocate, and author in New York City, who specializes in working with individuals diagnosed with chronic and catastrophic medical conditions, their caregivers, and professionals. (JustGotDiagnosed.com)
MAXIMILIAN IMAGING (MCCLAIN)
Get fully informed on your physician’s thinking behind their recommendation.
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The long-acting injectable Trogarzo is the first non-oral therapy of its kind.
clinical trial) access to the new drug while awaiting official FDA approval. That program was possible because the FDA had already declared ibalizumab a “breakthrough therapy.” “It has been more than a decade since ibalizumab moved to phase 2b development,” said Edwin DeJesus, M.D., medical director for the Orlando Immunology Center and an ibalizumab clinical trial investigator. “Early on, we knew the potential of this agent. However, I believe this long developmental process has served everyone well, especially in our ability to understand where this drug, which is the first drug to be administered intravenously for the treatment of [HIV], can best fit in our [medical armory]. Although we have waited a long time, ibalizumab now becomes available perhaps at a point in which it is most needed.” Ibalizumab was developed by Theratechnologies Inc. and showed to be effective in clinical trials, significantly decreased viral loads in participants after just a few weeks of treatment. Those results continued—and even improved—over the course of the study. Forty people with multi-drug resistant strains of HIV participated in the study, where they were either given injections of 2,000 mg of ibalizumab in addition to their (failing) antiretroviral therapies, or ibalizumab with no additional antiretrovirals. Like other antiretrovirals, ibalizumab’s success rate wasn’t high enough to justify it as a stand-alone drug but it will improve the effectiveness of combination therapy (all currently approved HIV regimens include multiple drugs). The new drug is particularly designed for people living with multidrug-resistant HIV whose current antiretroviral regimens are failing to keep them undetectable. In addition to being the first long-acting therapy, ibalizumab is the first HIV therapy with a new mechanism of action approved in a decade. It is in a new class of post-attachment inhibitors (PAIs), which bind to CD4 cells after HIV has attached to them, and inhibits the HIV virus from successfully corrupting the cells. Having a different mechanism of action is essential for those who’ve developed drug resistance, since becoming resistant to a class of
drugs often renders every drug in that class useless. Study participants weren’t solely resistant to a single HIV therapy, but showed resistance to nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, and protease inhibitors. More than 60 percent also had resistance to at least one integrase inhibitor. Some had become resistant to all the drug classes on the market. For those people, ibalizumab could literally be lifesaving. “We are at a crossroads,” DeJesus reiterated, “where we have developed great ARV therapies to treat our newly diagnosed HIV patients, and those who have failed, or poorly tolerated their second or third ARV regimen. For patients with no treatment options to build a potent new ARV regimen, this multidrug resistance can become a life or death situation. But even before that point is reached, this multi-drug resistance, and the inability to control the HIV [virus], can significantly reduce patient’s quality of life and promote the development of significant morbidities; something that we also need to avoid.” HIVPLUSMAG.COM
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