POZ June 2017

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WHAT IS GENVOYA®? GENVOYA is a 1-pill, once-a-day prescription medicine used to treat HIV-1 in people 12 years and older and weigh at least 77 lbs. It can either be used in people who are starting HIV-1 treatment and 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. These include having an undetectable viral load (less than 50 copies/mL) for 6 months or more on their current HIV-1 treatment. GENVOYA combines 4 medicines into 1 pill taken once a day with food. GENVOYA is a complete HIV-1 treatment and should not be used with other HIV-1 medicines. GENVOYA does not cure HIV-1 or AIDS. To control HIV-1 infection and decrease HIV-related illnesses, you must keep taking GENVOYA. Ask your healthcare provider if you have questions about how to reduce the risk of passing HIV-1 to others. Always practice safer sex and use condoms to lower the EJCPEG QH UGZWCN EQPVCEV YKVJ DQF[ ƃ WKFU 0GXGT TGWUG QT UJCTG PGGFNGU QT QVJGT KVGOU VJCV JCXG DQF[ ƃ WKFU QP VJGO

medicines that should not be taken with GENVOYA. Do not start a new medicine without telling your healthcare provider. • The herbal supplement St. John’s wort. • Any other medicines to treat HIV-1 infection.

What are the other possible side effects of GENVOYA? Serious side effects of GENVOYA may also include: • Changes in body fat, which can happen in people taking HIV-1 medicines. • Changes in your immune system. Your immune system may IGV UVTQPIGT CPF DGIKP VQ Ƃ IJV KPHGEVKQPU 6GNN [QWT JGCNVJECTG provider if you have any new symptoms after you start taking GENVOYA. • 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 GENVOYA.

IMPORTANT SAFETY INFORMATION

The most common side effect of GENVOYA is nausea. Tell your healthcare provider if you have any side effects that bother you or don’t go away.

What is the most important information I should know about GENVOYA?

What should I tell my healthcare provider before taking GENVOYA?

GENVOYA may cause serious side effects:

• All your health problems. Be sure to tell your healthcare provider if you have or have had any kidney or liver problems, including hepatitis virus infection.

• Build-up of an acid in your blood (lactic acidosis), which is a serious medical emergency. Symptoms of lactic acidosis include feeling very weak or tired, unusual muscle pain, trouble breathing, stomach pain with nausea or vomiting, feeling cold (especially in your arms and legs), feeling dizzy or lightheaded, and/or a fast or irregular heartbeat. • Serious liver problems. The liver may become large and fatty. Symptoms of liver problems include your skin or the white part of your eyes turning yellow (jaundice); dark “tea-colored” urine; light-colored bowel movements (stools); loss of appetite; nausea; and/or pain, aching, or tenderness in the right side of your stomach area. • You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight, or have been taking GENVOYA for a long time. In some cases, lactic acidosis and serious liver problems have led to death. Call your healthcare provider right away if you have any symptoms of these conditions. • Worsening of hepatitis B (HBV) infection. GENVOYA is not approved to treat HBV. If you have both HIV-1 and HBV and stop taking GENVOYA, your HBV may suddenly get worse. &Q PQV UVQR VCMKPI )'081;# YKVJQWV Ƃ TUV VCNMKPI VQ [QWT healthcare provider, as they will need to monitor your health.

Who should not take GENVOYA? Do not take GENVOYA if you take:

• All the medicines you take, including prescription and overthe-counter medicines, vitamins, and herbal supplements. Other medicines may affect how GENVOYA works. Keep a list of all your medicines and show it to your healthcare provider and pharmacist. Ask your healthcare provider if it is safe to take GENVOYA with all of your other medicines. • If you take antacids. Take antacids at least 2 hours before or after you take GENVOYA. • If you are pregnant or plan to become pregnant. It is not known if GENVOYA can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking GENVOYA. • If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please see Important Facts about GENVOYA including Important Warnings on the following page.

• Certain prescription medicines for other conditions. It is important to ask your healthcare provider or pharmacist about

Ask your healthcare provider if GENVOYA is right for you, and visit GENVOYA.com to learn more.

GENVOYA does not cure HIV-1 or AIDS.

SHOW YOUR

POWER

Take care of what matters most—you. GENVOYA is a 1-pill, once-a-day complete HIV-1 treatment for people who are either new to treatment or people whose healthcare provider determines they can replace their current HIV-1 medicines with GENVOYA.

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

(jen-VOY-uh) MOST IMPORTANT INFORMATION ABOUT GENVOYA

POSSIBLE SIDE EFFECTS OF GENVOYA

GENVOYA® may cause serious side effects, including: • Build-up of lactic acid in your blood (lactic acidosis), which is a serious medical emergency that can lead to death. Call your healthcare provider right away if you have any of these symptoms: feeling very weak or tired, unusual muscle pain, trouble breathing, stomach pain with nausea or vomiting, feeling cold (especially in your arms and legs), feeling dizzy or lightheaded, and/or a fast or irregular heartbeat. • Severe liver problems, which in some cases can lead to death. Call your healthcare provider right away if you have any of these symptoms: your skin or the white part of your eyes turns yellow (jaundice); dark “tea-colored” urine; light-colored bowel movements (stools); loss of appetite; nausea; and/or pain, aching, or tenderness in the right side of your stomach area. • Worsening of hepatitis B (HBV) infection. GENVOYA is not approved to treat HBV. If you have both HIV-1 and HBV, your HBV may suddenly get worse if you stop taking GENVOYA. Do not stop taking GENVOYA without first talking to your healthcare provider, as they will need to check your health regularly for several months. You may be more likely to get lactic acidosis or severe liver problems if you are female, very overweight, or have been taking GENVOYA for a long time.

GENVOYA can cause serious side effects, including: • Those in the “Most Important Information About GENVOYA” section. • Changes in body fat. • Changes in your immune system. • New or worse kidney problems, including kidney failure. The most common side effect of GENVOYA is nausea. These are not all the possible side effects of GENVOYA. Tell your healthcare provider right away if you have any new symptoms while taking GENVOYA. Your healthcare provider will need to do tests to monitor your health before and during treatment with GENVOYA.

ABOUT GENVOYA • GENVOYA is a prescription medicine used to treat HIV-1 in people 12 years of age and older and weigh at least 77 lbs who have never taken HIV-1 medicines before. GENVOYA can also be used to replace current HIV-1 medicines for some people who have an undetectable viral load (less than 50 copies/mL of virus in their blood), and have been on the same HIV-1 medicines for at least 6 months and have never failed HIV-1 treatment, and whose healthcare provider determines that they meet certain other requirements. • GENVOYA does not cure HIV-1 or AIDS. Ask your healthcare provider about how to prevent passing HIV-1 to others. Do NOT take GENVOYA if you: • Take a medicine that contains: alfuzosin (Uroxatral®), carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®, Tegretol-XR®, Teril®), cisapride (Propulsid®, Propulsid Quicksolv®), dihydroergotamine (D.H.E. 45®, Migranal®), ergotamine (Cafergot®, Migergot®, Ergostat®, Medihaler Ergotamine®, Wigraine®, Wigrettes®), lovastatin (Advicor ®, Altoprev®, Mevacor ®), lurasidone (Latuda®), methylergonovine (Ergotrate®, Methergine®), midazolam (when taken by mouth), phenobarbital (Luminal®), phenytoin (Dilantin®, Phenytek®), pimozide (Orap®), rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®), sildenafil when used for lung problems (Revatio®), simvastatin (Simcor®, Vytorin®, Zocor®), or triazolam (Halcion®). • Take the herbal supplement St. John’s wort. • Take any other HIV-1 medicines at the same time.

BEFORE TAKING GENVOYA Tell your healthcare provider if you: • Have or have had any kidney or liver problems, including hepatitis infection. • Have any other medical condition. • Are pregnant or plan to become pregnant. • Are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. Tell your healthcare provider about all the medicines you take: • Keep a list that includes all prescription and over-the-counter medicines, vitamins, and herbal supplements, and show it to your healthcare provider and pharmacist. • Ask your healthcare provider or pharmacist about medicines that should not be taken with GENVOYA.

HOW TO TAKE GENVOYA • GENVOYA is a complete one pill, once a day HIV-1 medicine. • Take GENVOYA with food.

GET MORE INFORMATION • This is only a brief summary of important information about GENVOYA. Talk to your healthcare provider or pharmacist to learn more. • Go to GENVOYA.com or call 1-800-GILEAD-5 • If you need help paying for your medicine, visit GENVOYA.com for program information.

GENVOYA, the GENVOYA Logo, GILEAD, the GILEAD Logo, and LOVE WHAT’S INSIDE are trademarks of Gilead Sciences, Inc., or its related companies. All other marks referenced herein are the property of their respective owners. Version date: December 2016 © 2017 Gilead Sciences, Inc. All rights reserved. GENC0126 01/17

We continue to be concerned about proposals like health savings accounts, ending or reducing essential health benefits or adding provisions that would allow insurers to charge much higher premiums that could emerge in legislation considered by Congress. Implementation of these ideas could put insurance costs beyond the reach of low-income people. Under these proposals, many may not have the ability to pay for the premiums and the copays necessary to obtain health care coverage or the drugs that they need. We also have to focus on ensuring that both the 2017 and 2018 budgets and appropriations bills do not cut vital health care and treatment services for people living with HIV, access to housing, HIV prevention efforts and programs for mental health and substance use treatment. The president continues to say that he wants to cut funding for these types of services, but they are absolutely critical to our national response to HIV. We will also continue to ensure that the Ryan White Program remains available for people living with HIV, and at a minimum, we want to make sure the funding for the program is stable. We would like to see it increased to meet the growing needs of people living with HIV.

Describe your efforts in the South.

Our Southern REACH (Regional Expansion of Access and Capacity to Address HIV/AIDS) initiative supports the policy and advocacy activities of communitybased organizations in nine states— Alabama, Florida, Georgia, Louisiana, Mississippi, North Carolina, South Carolina, Tennessee and Texas. The program targets a part of the country where resources are needed the most and where the epidemic needs to change. The program goals for this year will be to further infuse racial and social justice concepts into the work of the grantees. Intersectionality can take all of our efforts to the next level, but particularly in the South, where racial and social justice issues are still in need of aggressive approaches.

Jesse Milan Jr.

educating local and state officials about the need for greater funding and disrupting HIV-related stigma through a variety of programs led by HIV-positive people. You’ve been fighting HIV for decades. No one would blame you for hanging up your hat. Why are you still fighting?

Yes, in fact, I’ve definitely decided not to hang up my hat! I threw my hat into the ring to be interim president and CEO and then threw my hat in again to be chosen for this role permanently. I come from a family that never stops. To this day, my father is still a civil rights leader in Kansas, and my mother was a busy volunteer literally until the day she died. I live by a code that goes like this: “To whom much is given, much shall be required.”

“ The new political environment demands more from all of us.”

COURTESY OF JESSE MILAN JR.

Tell us about AIDSWatch 2017.

This year’s event was the largest we’ve had. We were excited to bring together all the many voices and stakeholders for HIV/AIDS to coalesce around the policy agenda that I just described and to deploy themselves to meet face-to-face with legislators in both the House and the Senate. This year, we hoped to harness the anger and the anxiety that so many HIV stakeholders are feeling and direct that energy into a productive advocacy process that allowed us to tell our stories. We also wanted to articulate that the funding by the U.S. government has had a real impact not only on the lives of people with HIV but also on the whole economy. Living under a former CEO as president, it’s important in this new environment that all of us become savvier about the return on investment that public and private funders are making in HIV and be conversant with how we describe that investment.

The combination of bringing racial and social justice to the HIV/AIDS arena and taking HIV/AIDS into the racial and social justice arena hopefully will move both agendas forward, but especially so for people living with HIV in the South. The South is a battlefield not only for Medicaid expansion, since many of those states haven’t expanded it, but also for HIV criminalization laws. Those battles will be won mostly in state legislatures and not at the federal level. We will help build the power needed for these issues. In addition to Southern REACH, AIDS United manages a significant program called the Positive Organizing Project (POP), which is focused on bringing meaningful engagements of people living with HIV/AIDS into not only organizational leadership but also state, local and national leadership. POP grantees are addressing state criminalization laws,

I have been blessed with so much from my family, friends and supporters, from mentors and employers, so I can’t stop. I’m glad I haven’t stopped because I feel like the new political environment demands more from all of us, and because of that, it demands more from me. How can folks get more involved?

If you can put in time, then volunteer. If you can put in money, then donate. The important thing is to find what calls to you personally. When you are committed to a mission, your desire to give and do more will be boundless. Living with HIV is a daily challenge, but we meet that challenge when we’re supported by others and when we support others. I’m lucky to have a network of people also living with HIV for support. I hope all POZ readers can find that network and support for themselves. ■

poz.com JUNE 2017 POZ 7

WHAT IS PREZCOBIX®?

• It is not known if PREZCOBIX® is safe and effective in children under 18 years of age. • When used with other antiretroviral medicines to treat HIV-1 infection, PREZCOBIX® may help: ○ reduce the amount of HIV-1 in your blood. This is called “viral load.” ○ increase the number of CD4+ (T) cells in your blood that help fight off other infections. • PREZCOBIX® is always taken in combination with other HIV medications for the treatment of HIV-1 infection in adults. PREZCOBIX® should be taken once daily with food. • PREZCOBIX® does not cure HIV-1 infection or AIDS, and you may still experience illnesses associated with HIV-1 infection. You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses. • Ask your healthcare provider if you have any questions on how to prevent passing HIV to other people. • Please read the Important Safety Information below and talk to your healthcare provider to learn if PREZCOBIX® is right for you.

IMPORTANT SAFETY INFORMATION What is the most important information I should know about PREZCOBIX®? ®

• PREZCOBIX may cause liver problems. Some people taking PREZCOBIX® may develop liver problems which may be life-threatening. Your healthcare provider should do blood tests before and during your treatment with PREZCOBIX.® ○ Chronic hepatitis B or C infection may increase your chance of developing liver problems. Your healthcare provider should check your blood tests more often. ○ Signs and symptoms of liver problems include dark (tea-colored) urine, yellowing of your skin or whites of your eyes, pale-colored stools (bowel movements), nausea, vomiting, pain or tenderness on your right side below your ribs, or loss of appetite. Tell your healthcare provider if you develop any of these symptoms. • PREZCOBIX® may cause severe or life-threatening skin reactions or rash. Sometimes these skin reactions and skin rashes can become severe and require treatment in a hospital. Call your healthcare provider right away if you develop a rash. ○ Stop taking PREZCOBIX® and call your healthcare provider right away if you develop any skin changes with symptoms such as fever, tiredness, muscle or joint pain, blisters or skin lesions, mouth sores or ulcers, red or inflamed eyes like “pink eye” (conjunctivitis). ®

• PREZCOBIX, when taken with certain other medicines, can cause new or worse kidney problems, including kidney failure. Your healthcare provider should check your kidneys before you start and while you are taking PREZCOBIX.®

Ergostat®, Medihaler®, Migergot®, Wigraine®, Wigrettes®), methylergonovine (Methergine®), lovastatin or a product that contains lovastatin (Altoprev®, Advicor®, Mevacor®), lurasidone (Latuda®), oral midazolam (Versed®), phenobarbital (Luminal®), phenytoin (Dilantin®, Dilantin-125®, Phenytek®), pimozide (Orap®), ranolazine (Ranexa®), rifampin (Rifadin®, Rifater®, Rifamate®, Rimactane®), sildenafil (Revatio®) when used for pulmonary arterial hypertension (PAH), simvastatin or a product that contains simvastatin (Simcor®, Vytorin®, Zocor®), St. John’s Wort (Hypericum perforatum) or a product that contains St. John’s Wort, or triazolam (Halcion®). • Serious problems can happen if you take any of these medicines with PREZCOBIX.® What should I tell my healthcare provider before taking PREZCOBIX®? • About all health problems. Tell your healthcare provider if you have liver problems, including hepatitis B or hepatitis C, have kidney problems, are allergic to sulfa (sulfonamide), have diabetes, have hemophilia, or have any other medical condition, are pregnant, breastfeeding, or plan to become pregnant or breastfeed. Tell your healthcare provider if you become pregnant while taking PREZCOBIX.® • About all medicines you take. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with PREZCOBIX.® Keep a list of your medicines to show your healthcare provider and pharmacist. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take PREZCOBIX® with other medicines. What are the possible side effects of PREZCOBIX®? • The most common side effects of darunavir, one of the medicines in PREZCOBIX,® include diarrhea, nausea, rash, headache, stomach area (abdominal) pain, and vomiting. • Other possible side effects include: ○ High blood sugar, diabetes or worsening diabetes, and increased bleeding in people with hemophilia have been reported in patients taking protease inhibitor medicines, including PREZCOBIX.® ○ Changes in body fat can happen in people who take HIV-1 medicines. The exact cause and long-term health effects of these changes are not known. ○ Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. These are not all of the possible side effects of PREZCOBIX.® For more information, ask your healthcare provider. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736). Please see full Product Information for more details.

®

Who should not take PREZCOBIX ? • Do not take PREZCOBIX® with any of the following medicines: alfuzosin (Uroxatral®), carbamazepine (Carbatrol® Epitol®, Equetro®, Tegretol®, Tegretol-XR®, Teril®) cisapride (Propulsid®), colchicine (Colcrys®, Mitigare®, if you have liver or kidney problems), dronedarone (Multaq®), elbasvir and grazoprevir (Zepatier®), dihydroergotamine (D.H.E.45®, Migranal®), ergotamine tartrate (Cafergot®, Ergomar®,

Janssen Therapeutics, Division of Janssen Products, LP © Janssen Therapeutics, Division of Janssen Products, LP 2017 03/17 068105-170228

061037-161017

• PREZCOBIX® is a prescription HIV-1 (Human Immunodeficiency Virus 1) medicine used with other antiretroviral medicines to treat HIV-1 infection in adults. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). PREZCOBIX® contains the prescription medicines PREZISTA® (darunavir) and TYBOST® (cobicistat).

“RESISTANCE IS A RISK I TAKE SERIOUSLY.” Everyone is at risk of developing drug resistance. So when deciding on an HIV treatment, think long-term. Once-Daily* PREZCOBIX® has a high genetic barrier to resistance, which may help. *

PREZCOBIX® is taken in combination with other HIV medications for the treatment of HIV-1 infection in adults.

Wisdom inspired by real people

ASK YOUR DOCTOR ABOUT DRUG RESISTANCE AND ONCE-DAILY

*

PREZCOBIX.com

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“Learning is part of my journey. Asking questions helps me feel more confident.”

PREZCOBIX® (prez-koe-bix) (darunavir and cobicistat) tablets What is PREZCOBIX® used for? PREZCOBIX® is a prescription HIV-1 (Human Immunodeficiency Virus 1) medicine used with other antiretroviral medicines to treat HIV-1 infection in adults. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). PREZCOBIX® contains prescription medicines PREZISTA® (darunavir) and TYBOST® (cobicistat). PREZCOBIX® does not cure HIV-1 infection or AIDS. You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses. What are the most serious warnings about PREZCOBIX®? • PREZCOBIX® may cause liver problems which may be life-threatening. Tell your healthcare provider right away if you have any symptoms such as: • Vomiting • Dark (tea-colored) urine • Pain or tenderness on your right side below your ribs • Yellowing of your skin or the whites of your eyes • Loss of appetite • Pale-colored stools (bowel movements) • Nausea • PREZCOBIX® may cause severe or life-threatening skin reactions or rashes. Stop taking PREZCOBIX® and call your healthcare provider right away if you develop any skin changes with symptoms below: • Blisters or skin lesions • Fever • Mouth sores or ulcers • Tiredness • Red or inflamed eyes, like “pink eye” (conjunctivitis) • Muscle or joint pain • PREZCOBIX,® when taken with some other medications, can cause new or worse kidney problems, including kidney failure. What do I need to tell my healthcare provider? Tell your healthcare provider if you: • Have liver problems, including hepatitis B or hepatitis C • Have kidney problems • Are allergic to sulfa (sulfonamide) • Have diabetes • Have hemophilia • Have any other medical condition

• Are pregnant or plan to become pregnant. (It is not known if PREZCOBIX® will harm your unborn baby. Tell your healthcare provider if you become pregnant while taking PREZCOBIX.®) • Are breastfeeding or plan to breastfeed. Do not breastfeed if you take PREZCOBIX® because it is unknown if PREZCOBIX® can pass into your breast milk. You should not breastfeed if you have HIV-1 because of the risk of passing HIV to your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medications may prevent PREZCOBIX® from working or cause increased side effects. Do not start taking a new medicine without telling your healthcare provider. Who should not take PREZCOBIX®? • Do not take PREZCOBIX® with any of the following medicines: alfuzosin (Uroxatral®), carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®, Tegretol-XR®, Teril®), cisapride (Propulsid®), colchicine (Colcrys®, Mitigare,® if you have liver or kidney problems), dronedarone (Multaq®), elbasvir and grazoprevir (Zepatier®), dihydroergotamine (D.H.E.45®, Migranal®), ergotamine tartrate (Cafergot ,® Ergomar ®, Ergostat ,® Medihaler,® Migergot,® Wigraine,® Wigrettes®), methylergonovine (Methergine®), lovastatin or a product that contains lovastatin (Altoprev,® Advicor,® Mevacor ®), lurasidone (Latuda®), oral midazolam (Versed®), phenobarbital (Luminal®), phenytoin (Dilantin®, Dilantin-125®, Phenytek®), pimozide (Orap®), ranolazine (Ranexa®), rifampin (Rifadin,® Rifater®, Rifamate,® Rimactane®), sildenafil (Revatio®) when used for pulmonary arterial hypertension (PAH), simvastatin or a product that contains simvastatin (Simcor,® Vytorin,® Zocor ®), St. John’s Wort (Hypericum perforatum) or a product that contains St. John’s Wort, or triazolam (Halcion®). • Serious problems can happen if you take any of these medicines with PREZCOBIX.® What are the possible side effects of PREZCOBIX®? PREZCOBIX® may cause serious side effects including: • Diabetes and high blood sugar • Changes in body fat can happen in people taking HIV-1 medications • Immune system changes (Immune Reconstitution Syndrome) can happen in people who start HIV-1 medications • Increased bleeding can occur in people with hemophilia who are taking PREZCOBIX.® The most common side effects are: • Diarrhea • Headache • Nausea • Stomach area (abdominal) pain • Rash • Vomiting These are not all of the possible side effects of PREZCOBIX®. For more information, ask your healthcare provider. What should I know about this Brief Summary? This information is not complete. To get more information: • Talk to your healthcare provider or pharmacist • Visit www.PREZCOBIX.com to read over the FDA-approved product labeling and patient information • Call to report side effects either to the FDA at 1-800-FDA-1088 or to Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736). © Janssen Therapeutics, Division of Janssen Products, LP 2016 10/16 054195-160602

How does HIV affect my future? It doesn’t. Let’s Grow Old Together See what life with HIV looks like from diagnosis through grandkids with a little help from Walgreens. Explore Calvin’s HIV journey at Walgreens.com/LetsGrowOldTogether. ©2017 Walgreen Co. All rights reserved.

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YOU MATTER AND SO DOES YOUR HEALTH That’s why starting and staying on HIV-1 treatment is so important.

What is DESCOVY ?

What are the other possible side effects of DESCOVY?

DESCOVY is a prescription medicine that is used together with other HIV-1 medicines to treat HIV-1 in people 12 [GCTU CPF QNFGT &'5%18; KU PQV HQT WUG VQ JGNR TGFWEG VJG TKUM QH IGVVKPI *+8 KPHGEVKQP &'5%18; EQODKPGU medicines into 1 pill taken once a day. Because DESCOVY D[ KVUGNH KU PQV C EQORNGVG VTGCVOGPV HQT *+8 KV OWUV DG used together with other HIV-1 medicines.

Serious side effects of DESCOVY may also include:

®

DESCOVY does not cure HIV-1 infection or AIDS. 6Q EQPVTQN *+8 KPHGEVKQP CPF FGETGCUG *+8 TGNCVGF illnesses, you must keep taking DESCOVY. Ask your JGCNVJECTG RTQXKFGT KH [QW JCXG SWGUVKQPU CDQWV JQY VQ TGFWEG VJG TKUM QH RCUUKPI *+8 VQ QVJGTU #NYC[U RTCEVKEG UCHGT UGZ CPF WUG EQPFQOU VQ NQYGT VJG EJCPEG QH UGZWCN EQPVCEV YKVJ DQF[ ƃ WKFU 0GXGT TGWUG QT UJCTG PGGFNGU QT QVJGT KVGOU VJCV JCXG DQF[ ƃ WKFU QP VJGO

IMPORTANT SAFETY INFORMATION What is the most important information I should know about DESCOVY? DESCOVY may cause serious side effects: •

Buildup of an acid in your blood (lactic acidosis), which is C UGTKQWU OGFKECN GOGTIGPE[ 5[ORVQOU QH NCEVKE CEKFQUKU KPENWFG HGGNKPI XGT[ YGCM QT VKTGF WPWUWCN OWUENG RCKP trouble breathing, stomach pain with nausea or vomiting, HGGNKPI EQNF GURGEKCNN[ KP [QWT CTOU CPF NGIU HGGNKPI FK\\[ QT NKIJVJGCFGF CPF QT C HCUV QT KTTGIWNCT JGCTVDGCV

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Serious liver problems. 6JG NKXGT OC[ DGEQOG NCTIG CPF HCVV[ 5[ORVQOU QH NKXGT RTQDNGOU KPENWFG [QWT UMKP QT VJG YJKVG RCTV QH [QWT G[GU VWTPKPI [GNNQY LCWPFKEG FCTM pVGC EQNQTGFq WTKPG NKIJV EQNQTGF DQYGN OQXGOGPVU

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You may be more likely to get lactic acidosis or serious liver problems KH [QW CTG HGOCNG XGT[ QXGTYGKIJV QT JCXG DGGP VCMKPI &'5%18; HQT C NQPI time. In some cases, lactic acidosis and serious liver problems have led to death. Call your healthcare provider TKIJV CYC[ KH [QW JCXG CP[ U[ORVQOU QH VJGUG EQPFKVKQPU

•

Worsening of hepatitis B (HBV) infection. DESCOVY KU PQV CRRTQXGF VQ VTGCV *$8 +H [QW JCXG DQVJ *+8 CPF HBV and stop taking DESCOVY, your HBV may suddenly IGV YQTUG &Q PQV UVQR VCMKPI &'5%18; YKVJQWV Æ‚ TUV talking to your healthcare provider, as they will need to monitor your health.

•

Changes in body fat, which can happen in people taking HIV-1 medicines.

•

Changes in your immune system. Your immune system OC[ IGV UVTQPIGT CPF DGIKP VQ Æ‚ IJV KPHGEVKQPU 6GNN [QWT JGCNVJECTG RTQXKFGT KH [QW JCXG CP[ PGY U[ORVQOU CHVGT you start taking DESCOVY.

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Kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys. Your healthcare provider may tell you VQ UVQR VCMKPI &'5%18; KH [QW FGXGNQR PGY QT YQTUG kidney problems.

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Bone problems, UWEJ CU DQPG RCKP UQHVGPKPI QT VJKPPKPI YJKEJ OC[ NGCF VQ HTCEVWTGU ;QWT JGCNVJECTG provider may do tests to check your bones.

The most common side effect QH &'5%18; KU PCWUGC 6GNN [QWT JGCNVJECTG RTQXKFGT KH [QW JCXG CP[ UKFG GHHGEVU that bother you or don’t go away.

What should I tell my healthcare provider before taking DESCOVY? •

All your health problems. Be sure to tell your healthcare RTQXKFGT KH [QW JCXG QT JCXG JCF CP[ MKFPG[ DQPG QT NKXGT RTQDNGOU KPENWFKPI JGRCVKVKU XKTWU KPHGEVKQP

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All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal UWRRNGOGPVU 1VJGT OGFKEKPGU OC[ CHHGEV JQY &'5%18; YQTMU -GGR C NKUV QH CNN [QWT OGFKEKPGU CPF show it to your healthcare provider and pharmacist. Ask [QWT JGCNVJECTG RTQXKFGT KH KV KU UCHG VQ VCMG &'5%18; YKVJ CNN QH [QWT QVJGT OGFKEKPGU

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If you are pregnant or plan to become pregnant. It is PQV MPQYP KH &'5%18; ECP JCTO [QWT WPDQTP DCD[ 6GNN [QWT JGCNVJECTG RTQXKFGT KH [QW DGEQOG RTGIPCPV while taking DESCOVY.

•

If you are breastfeeding PWTUKPI QT RNCP VQ DTGCUVHGGF &Q PQV DTGCUVHGGF *+8 ECP DG RCUUGF VQ VJG DCD[ KP breast milk.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/ medwatch, or call 1-800-FDA-1088. Please see Important Facts about DESCOVY, including important warnings, on the following page.

Ask your healthcare provider if an HIV-1 treatment that contains DESCOVY® is right for you.

IMPORTANT FACTS KLZ 26/ ]LL

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MOST IMPORTANT INFORMATION ABOUT DESCOVY

POSSIBLE SIDE EFFECTS OF DESCOVY

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â‚” )\PSK\W VM SHJ[PJ HJPK PU `V\Y ISVVK SHJ[PJ HJPKVZPZ , which is a serious medical emergency that can lead to death. Call your healthcare provider right away if you have any of these symptoms: feeling very weak or tired, unusual muscle pain, trouble breathing, stomach pain with nausea or vomiting, feeling cold (especially in your arms and legs), feeling dizzy or lightheaded, and/or a fast or irregular heartbeat.

ₔ Those in the “Most Important Information About DESCOVY� section. ₔ Changes in body fat. ₔ Changes in your immune system. ₔ New or worse kidney problems, including kidney failure. ₔ Bone problems.

â‚” :L]LYL SP]LY WYVISLTZ which in some cases can lead to death. Call your healthcare provider right away if you have any of these symptoms: your skin or the white part of your eyes turns yellow (jaundice); dark “tea-coloredâ€? urine; loss of appetite; light-colored bowel movements (stools); nausea; and/or pain, aching, or tenderness on the right side of your stomach area. â‚” >VYZLUPUN VM OLWH[P[PZ ) /)= PUMLJ[PVU DESCOVY is not approved to treat HBV. If you have both HIV-1 and HBV, your HBV may suddenly get worse if you stop taking DESCOVY. Do not stop taking DESCOVY without Ă„ YZ[ [HSRPUN [V `V\Y OLHS[OJHYL WYV]PKLY HZ [OL` ^PSS ULLK to check your health regularly for several months. You may be more likely to get lactic acidosis or severe liver problems if you are female, very overweight, or have been taking DESCOVY or a similar medicine for a long time.

ABOUT DESCOVY â‚” DESCOVY is a prescription medicine that is used together with other HIV-1 medicines to treat HIV-1 in people 12 years of age and older. DESCOVY is UV[ for use to help reduce the risk of getting HIV-1 infection. â‚” +,:*6=@ KVLZ UV[ J\YL /0= VY (0+:. Ask your healthcare provider about how to prevent passing HIV-1 to others.

;OL TVZ[ JVTTVU ZPKL L LJ[ VM +,:*6=@ is nausea. ;OLZL HYL UV[ HSS [OL WVZZPISL ZPKL L LJ[Z VM +,:*6=@ Tell your healthcare provider right away if you have any new symptoms while taking DESCOVY. @V\Y OLHS[OJHYL WYV]PKLY ^PSS ULLK [V KV [LZ[Z [V TVUP[VY `V\Y OLHS[O ILMVYL HUK K\YPUN [YLH[TLU[ ^P[O +,:*6=@

),-69, ;(205. +,:*6=@ ;LSS `V\Y OLHS[OJHYL WYV]PKLY PM `V\! â‚” Have or had any kidney, bone, or liver problems, including hepatitis infection. â‚” Have any other medical condition. â‚” Are pregnant or plan to become pregnant. â‚” Are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. ;LSS `V\Y OLHS[OJHYL WYV]PKLY HIV\[ HSS [OL TLKPJPULZ `V\ [HRL! â‚” Keep a list that includes all prescription and over-thecounter medicines, vitamins, and herbal supplements, and show it to your healthcare provider and pharmacist. â‚” Ask your healthcare provider or pharmacist about medicines that should not be taken with DESCOVY.

.,; 469, 05-694(;065 /6> ;6 ;(2, +,:*6=@ â‚” DESCOVY is a one pill, once a day HIV-1 medicine that is taken with other HIV-1 medicines. â‚” Take DESCOVY with or without food.

â‚” This is only a brief summary of important information about DESCOVY. Talk to your healthcare provider or pharmacist to learn more. â‚” Go to DESCOVY.com or call 1-800-GILEAD-5 â‚” If you need help paying for your medicine, visit DESCOVY.com for program information.

DESCOVY, the DESCOVY Logo, GILEAD, the GILEAD Logo, and LOVE WHAT’S INSIDE are trademarks of Gilead Sciences, Inc., or its related companies. All other marks referenced herein are the property of their respective owners. Š 2016 Gilead Sciences, Inc. All rights reserved. GILC0265 10/16

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