POZ October/November 2016 by Smart + Strong

A SMART+STRONG PUBLICATION OCTOBER/NOVEMBER 2016 POZ.COM $3.99

H E A L T H ,

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Center Stage Living with HIV and leading Hamilton on Broadway

Javier MuÃ±oz

A SMART+STRONG PUBLICATION OCTOBER/NOVEMBER 2016 POZ.COM $3.99

H E A L T H ,

L I F E

H I V

Center Stage Living with HIV and leading Hamilton on Broadway

Javier MuÃ±oz

HEALTHIER LIFE LIFE CAN CAN START START AA HEALTHIER WITH HIV HIV TREATMENT. TREATMENT. WITH

Starting HIV treatment right after diagnosis Starting HIV treatment right after diagnosis can help stop the virus in your body. Because can help stop the virus in your body. Because treatment helps lower the damage HIV causes treatment helps lower the damage HIV causes to your immune system. Plus, doctors and to your immune system. Plus, doctors and scientists have found that it can help lower scientists have found that it can help lower the risk of heart disease and certain cancers. the risk of heart disease and certain cancers.

TREATMENT ALSO ALSO HELPS HELPS YOU YOU PROTECT PROTECT OTHERS. OTHERS. TREATMENT HIV treatment can help lower the amount HIV treatment can help lower the amount of virus in your body. It can get so low, it of virus in your body. It can get so low, it can’t be measured by a test. It’s called being can’t be measured by a test. It’s called being undetectable. And it helps lower the chance undetectable. And it helps lower the chance of passing HIV on to others by more than 90%. of passing HIV on to others by more than 90%.

TALK TOTO YOUR YOUR HEALTHCARE HEALTHCARE PROVIDER. PROVIDER. TALK

STOPPING T CAN START

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Have an open conversation. When you work Have an open conversation. When you work together it helps your healthcare provider find the together it helps your healthcare provider find the treatment that’s right for you. treatment that’s right for you.

Watch HIV: “Treat 2 Prevent” Watch HIV: “Treat 2 Prevent” See how staying on treatment can help See how staying on treatment can help protect you and the people you care about. protect you and the people you care about. YouTube.com/HelpStopTheVirus YouTube.com/HelpStopTheVirus

Get the answe Get the answer privately, on y privately, on y HIVanswers HIVanswers.

THE VIRUS WITH YOU.

START HIV TREATMENT. HELPPROTECT PROTECTYOUR YOURHEALTH. HEALTH. HELP

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There is no cure for HIV, but find out how treatment There is no cure for HIV, but find out how treatment helps make it possible to live a healthy life. helps make it possible to live a healthy life. See See Inside Inside

CONTENTS

EXCLUSIVELY ON

POZ.COM

Javier Muñoz is open about his HIV to help ﬁght stigma.

POZ BLOGS

PERSONAL PERSPECTIVES Our roster of bloggers spans the diversity of the HIV/AIDS epidemic. Go to poz.com/blogs to read varying points of view from people living with the virus, as well as from HIV-negative advocates. Join the conversation in the comments section. Find hope and inspiration from others.

POZ OPINIONS

COMMENTARY ON HIV/AIDS

POZ DIGITAL

READ THE PRINT MAGAZINE ON YOUR COMPUTER OR TABLET

Go to poz.com/digital to view the current issue and the entire Smart + Strong digital library.

iSTAYHEALTHY FREE APP FROM POZ

Go to blogs.poz.com/istayhealthy or scan the QR code below with your mobile device to learn how you can better track your lab test results and meds, as well as set alerts to take your meds and more!

28 IN THE SPOTLIGHT After taking center stage in Broadway’s Hamilton, Javier Muñoz reﬂects on his HIV journey. BY ORIOL R. GUTIERREZ JR.

35 RUNWAY REALNESS A front-row seat at GMHC’s Latex Ball. BY JOE MEJIA 38 DECISION 2016: THE POLITICS OF A PANDEMIC National, state and local politics will affect HIV prevention, care and treatment—at home and abroad. BY BENJAMIN RYAN 3 FROM THE EDITOR

15 SPOTLIGHT

This Land Is Your Land

The buzz on undetectable

8 POZ Q+A

19 CARE AND TREATMENT

Miriam Y. Vega, CEO of UMMA Community Clinic in South Los Angeles, on integrating HIV into community-based organizations

ARVs nearly halt transmission through breast-feeding • the war on drugs fuels the spread of disease • undetectable = no transmission • PARTNER trial updates

10 POZ PLANET Daniel D. Driffin speaks about HIV at the DNC • a very, very long-term survivor • HMM works to update laws that criminalize HIV • a group for HIV-positive Muslims holds its first retreat • “Empowered: Trans Women & HIV” • POZ Stories: Billy Duckett • should Grindr allow its users to filter guys by their HIV status? • spreading the word about “negligible risk” when undetectable

26 RESEARCH NOTES

Vaginal ring that lowers HIV risk • monthly treatment with an injectable • scientists create a cure consortium • PEPFAR funding distributed disproportionately

27 SURVEY SAYS Have you ever experienced discrimination related to your HIV status?

14 VOICES

44 POZ HEROES

After the shootings at Pulse, filmmaker and Orlando native Cecilia Aldarondo writes about the sanctuary of gay clubs.

Originally from Peru and now living in Florida, Arianna Lint fights for transgender empowerment and HIV prevention.

POZ (ISSN 1075-5705) is published monthly except for the January/February, April/May, July/August and October/November issues ($19.97 for a 8-issue subscription) by Smart + Strong, 212 West 35th Street, 8th Floor, New York, NY 10001. Periodicals postage paid at New York, NY, and additional mailing offices. Issue No. 215. POSTMASTER: Send address changes to POZ, PO Box 8788, Virginia Beach, VA 23450-4884. Copyright © 2016 CDM Publishing, LLC. All rights reserved. No part of this publication may be reproduced, stored in any retrieval system or transmitted, in any form by any means, electronic, mechanical, photocopying, recording or otherwise without the written permission of the publisher. Smart + Strong® and POZ® are registered trademarks of CDM Publishing, LLC.

MUÑOZ, COVER AND THIS PAGE: (PHOTOGRAPHY) BILL WADMAN; (GROOMING) AMBER AMOS; (STYLING) THOMAS CARTER PHILLIPS; (SHIRT) THEORY; (PAINTING BY MIKE SOLOMON) COURTESY OF BERRY CAMPBELL © MIKE SOLOMON; (MEGAPHONE AND SPEECH BUBBLES) THINKSTOCK

Advocates, researchers, politicians, thought leaders and folks just like you all have ideas worth sharing. Go to poz.com/opinions to read about topics such as living with HIV, improving care and treatment, increasing prevention efforts and ﬁghting for social justice.

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:

Medihaler,® Migergot,® Wigraine,® Wigrettes®), methylergonovine (Methergine®), lovastatin or a product that contains lovastatin (Altoprev,® Advicor,® Mevacor ®), lurasidone (Latuda®), oral midazolam (Versed®), 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®).

○ reduce the amount of HIV-1 in your blood. This is called “viral load.”

• Serious problems can happen if you take any of these medicines with PREZCOBIX.®

○ increase the number of CD4+ (T) cells in your blood that help fight off other infections.

What should I tell my healthcare provider before taking PREZCOBIX®?

• 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.

• 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.

IMPORTANT SAFETY INFORMATION

What are the possible side effects of PREZCOBIX®?

What is the most important information I should know about 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.

• 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.® Who should not take PREZCOBIX®? • Do not take PREZCOBIX® with any of the following medicines: alfuzosin (Uroxatral®), cisapride (Propulsid,® Propulsid® Quicksolv), colchicine (Colcrys,® Mitigare®, if you have liver or kidney problems), dronedarone (Multaq®), dihydroergotamine (D.H.E.45®, Embolex ®, Migranal®), ergotamine tartrate (Cafergot ®, Ergomar ,® Ergostat ,®

• 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. Please see accompanying full Product Information for more details. Janssen Therapeutics, Division of Janssen Products, LP

027409-150618

• 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).

ASK YOUR DOCTOR ABOUT DRUG RESISTANCE AND ONCE-DAILY* PREZCOBIX®

Wisdom inspired by real people

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“I’M TAKING STEPS TO PROTECT MY TOMORROW.” When deciding on an HIV treatment, think long-term. Everyone is at risk of developing drug resistance. 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.

ONCE-DAILY

PREZCOBIX.com

IMPORTANT PATIENT INFORMATION PATIENT INFORMATION PREZCOBIX® (prez-koe-bix) (darunavir and cobicistat) tablets Please read this information before you start taking PREZCOBIX and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. 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 lifethreatening. Your healthcare provider should do blood tests before and during your treatment with PREZCOBIX. If you have chronic hepatitis B or C infection, your healthcare provider should check your blood tests more often because you have an increased chance of developing liver problems. Tell your healthcare provider if you have any of the below signs and symptoms of liver problems. • 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 • loss of appetite • 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 below: • 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. See “What are the possible side effects of PREZCOBIX?” for more information about side effects. What is PREZCOBIX? 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). 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. Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections). 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. Avoid doing things that can spread HIV-1 infection to others. • Do not share or re-use needles or other injection equipment. • Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades. • Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood. Ask your healthcare provider if you have any questions on how to prevent passing HIV to other people. Who should not take PREZCOBIX? Do not take PREZCOBIX with any of the following medicines: • alfuzosin (Uroxatral®) • cisapride (Propulside®, Propulsid® Quicksolv) • colchicine (Colcrys®, Mitigare®), if you have liver or kidney problems • dronedarone (Multaq®) • ergot-containing medicines: • dihydroergotamine (D.H.E. 45®, Embolex®, Migranal®) • ergotamine tartrate (Cafergot®, Ergomar®, Ergostat®, Medihaler®, Migergot®, Wigraine®, Wigrettes®) • methylergonovine (Methergine®) • lovastatin or a product that contains lovastatin (Altoprev®, Advicor®, Mevacor®) • lurasidone (Latuda®) • midazolam (Versed®), when taken by mouth • pimozide (Orap®) • ranolazine (Ranexa®) • rifampin (Rifadin®, Rifater®, Rifamate®, Rimactane®) • sildenafil (Revatio®), when used for the treatment of 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 • 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? Before taking PREZCOBIX, 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

IMPORTANT PATIENT INFORMATION • 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. • Pregnancy Registry: There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry. • are breastfeeding or plan to breastfeed. Do not breastfeed if you take PREZCOBIX. • You should not breastfeed if you have HIV-1 because of the risk of passing HIV to your baby. • It is not known if PREZCOBIX can pass into your breast milk. • Talk to your healthcare provider about the best way to feed your baby. 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. • You can ask your healthcare provider or pharmacist for a list of medicines that interact with PREZCOBIX. • 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. How should I take PREZCOBIX? • Take PREZCOBIX exactly as your healthcare provider tells you. • Do not change your dose or stop taking PREZCOBIX without talking to your healthcare provider. • Take PREZCOBIX 1 time a day with food. • If you miss a dose of PREZCOBIX by less than 12 hours, take your missed dose of PREZCOBIX right away. Then take your next dose of PREZCOBIX at your regularly scheduled time. • If you miss a dose of PREZCOBIX by more than 12 hours, wait and then take the next dose of PREZCOBIX at your regularly scheduled time. • If a dose of PREZCOBIX is skipped, do not double the next dose. Do not take more or less than your prescribed dose of PREZCOBIX at any one time. • If you take too much PREZCOBIX, call your healthcare provider or go to the nearest hospital emergency room right away. What are the possible side effects of PREZCOBIX? PREZCOBIX may cause serious side effects including: • See “What is the most important information I should know about PREZCOBIX?” • Diabetes and high blood sugar (hyperglycemia). Some people who take protease inhibitors including PREZCOBIX can get high blood sugar, develop diabetes, or your diabetes can get worse. Tell your healthcare provider if you notice an increase in thirst or urinate often while taking PREZCOBIX. • Changes in body fat can happen in people who take HIV-1 medications. The changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms, and face may also happen.

The exact cause and long-term health effects of these conditions are not known. • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after starting your HIV-1 medicine. • Increased bleeding for hemophiliacs. Some people with hemophilia have increased bleeding with protease inhibitors including PREZCOBIX. The most common side effects of darunavir, one of the medicines in PREZCOBIX, include: • diarrhea • nausea • rash • headache • stomach area (abdominal) pain • vomiting Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of PREZCOBIX. For more information, ask your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store PREZCOBIX? • Store PREZCOBIX tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep PREZCOBIX and all medicines out of reach of children. General information about PREZCOBIX Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use PREZCOBIX for a condition for which it was not prescribed. Do not give PREZCOBIX to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about PREZCOBIX that is written for health professionals. For more information call 1-800-526-7736. What are the ingredients in PREZCOBIX? Active ingredients: darunavir and cobicistat Inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, and silicified microcrystalline cellulose. The tablets are film-coated with a coating material containing iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide. Manufactured by: Janssen Ortho LLC, Gurabo, PR 00778 Manufactured for: Janssen Therapeutics, Division of Janssen Products, LP, Titusville NJ 08560 Revision Date: 03 2016 © Janssen Pharmaceuticals, Inc. 2015 050736-160405

I AM TO BE

URED In clinical studies, 96–99% of patients with genotype 1 who had no prior treatment were cured with just 12 weeks of therapy.*

* In a study of 865 patients with genotype 1 Hep C and no prior Hep C treatment, with or without advanced liver disease (cirrhosis), 99% (210 out of 213) of those who received HARVONI once daily for 12 weeks were cured. In a separate study of 647 patients with genotype 1 Hep C, with no prior Hep C treatment and without cirrhosis, 96% (208 out of 216) of those who received HARVONI once daily for 12 weeks were cured. † In the study of 647 patients with genotype 1 Hep C, with no prior Hep C treatment and without cirrhosis, 97% (119 out of 123) of those with lower levels of the virus (less than 6 million IU/mL) who received HARVONI once daily for 8 weeks were cured. These studies did not include patients with liver failure or those who have had a liver transplant. ‡ Based on prescription data for U.S. patients starting Hep C treatment with advanced treatment regimens (including direct-acting antiviral medicines) from 5/2011–12/2015. ¶

TODAY THERE’S HARVONI. A BREAKTHROUGH TREATMENT FOR HEPATITIS C. Now, more people have been prescribed HARVONI to cure their Hep C than any other advanced treatment regimen.‡ HARVONI is a prescription medicine used with or without ribavirin to treat chronic (lasting a long time) hepatitis C (Hep C) genotype 1, 4, 5 or 6 infection. It is not known if HARVONI is safe and effective in children under 18 years of age. HARVONI has been proven to cure up to 99% of patients with genotype 1 (the most common type of hepatitis C) who’ve had no prior Hep C treatment.* HARVONI transformed Hep C treatment as the first cure that’s one pill, once a day for 12 weeks. And for certain patients with genotype 1, HARVONI has been shown to be highly effective in as little as 8 weeks of treatment.† Your Hep C Specialist will decide what treatment length is right for you. Cure means the Hep C virus is not detected in the blood when measured three months after treatment is completed. With HARVONI, there’s no interferon and no complicated regimens. So, if you don’t want to live with the uncertainties of Hep C, now may be the time to talk to your Hep C Specialist about HARVONI.

IMPORTANT SAFETY INFORMATION

What should I tell my healthcare provider before taking HARVONI? • If you have: liver problems other than hepatitis C infection, or have had a liver transplant; severe kidney problems or are on dialysis; HIV, or any other medical condition; or if you are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if HARVONI will harm your unborn baby or pass into your breast milk. If you take HARVONI with ribavirin, you should also read the ribavirin Medication Guide for important pregnancy-related information. • Tell your healthcare provider and pharmacist about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. HARVONI and certain other medicines may affect each other, or may cause side effects. Tell your healthcare provider if you take any medicines containing tenofovir disoproxil fumarate (ATRIPLA®, COMPLERA®, STRIBILD®, TRUVADA®, VIREAD®). What are the possible side effects of HARVONI? • HARVONI, when taken with amiodarone (Cordarone®, Nexterone®, Pacerone®), a medicine used to treat certain heart problems, may cause serious side effects, including slow heart rate, which in some cases has led to death or the need for a pacemaker. Get medical help right away if you take amiodarone with HARVONI and get any of the following symptoms: fainting or near-fainting, dizziness or lightheadedness, not feeling well, weakness, extreme tiredness, shortness of breath, chest pains, confusion, or memory problems. • The most common side effects of HARVONI include tiredness, headache and weakness. 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. Are you ready for HARVONI? Ask your Hep C Specialist if HARVONI is right for you and visit HARVONI.com or call 1-844-READY41. Please see Important Facts about HARVONI on the following page.

THE ONE YOU’VE BEEN WAITING FOR

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

(har-VOE-nee) ABOUT HARVONI

BEFORE TAKING HARVONI

HARVONI is a prescription medicine used with or without ribavirin to treat chronic (lasting a long time) hepatitis C genotype 1, 4, 5 or 6 infection in adults. It is not known if HARVONI is safe and effective in children under 18 years of age.

Tell your healthcare provider if you have: • Liver problems other than hepatitis C infection • Had a liver transplant • Severe kidney problems or you are on dialysis • HIV infection • Any other medical condition Tell your healthcare provider about all the medicines you take: • Keep a list that includes all prescription and over-thecounter medicines, vitamins, and herbal supplements, and show it to your healthcare provider. • Including any medicines containing tenofovir disoproxil fumarate (ATRIPLA®, COMPLERA®, STRIBILD®, TRUVADA®, VIREAD®). • If you take HARVONI with ribavirin, you should also read the ribavirin Medication Guide for important pregnancy-related information.

POSSIBLE SIDE EFFECTS OF HARVONI HARVONI, when taken with amiodarone (Cordarone®, Nexterone®, Pacerone®), a medicine used to treat certain heart problems, may cause serious side effects, including slow heart rate, which in some cases has led to death or the need for a pacemaker. Get medical help right away if you take amiodarone with HARVONI and get any of the following symptoms: • fainting or near-fainting • dizziness or lightheadedness • not feeling well • weakness • extreme tiredness • shortness of breath • chest pains • confusion • memory problems The most common side effects include tiredness, headache and weakness. These are not all the possible side effects of HARVONI. Tell your healthcare provider if you have any new symptoms while taking HARVONI.

HARVONI and certain medicines may affect each other, or cause side effects.

GET MORE INFORMATION • This is only a brief summary of important information about HARVONI. Talk to your healthcare provider or pharmacist to learn more. • Go to HARVONI.com or call 1-844-READY41 • If you need help paying for your medicine call 1-855-7-MYPATH or go to HARVONI.com/support

Retail Pharmacy prescription data from IMS NPA New to Brand™ U.S. patient starts between 5/2011 and 12/2015. HARVONI, the HARVONI logo, COMPLERA, STRIBILD, TRUVADA, VIREAD, GILEAD and the GILEAD logo are trademarks of Gilead Sciences, Inc., or its related companies. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other trademarks referenced herein are the property of their respective owners. ©2016 Gilead Sciences, Inc. All rights reserved. HVNC0488 03/16

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WHAT IS ODEFSEY®?

What are the other possible side effects of ODEFSEY?

ODEFSEY is a 1-pill, once-a-day prescription medicine used to treat HIV-1 in people 12 years and older. It can either be used in people who are starting HIV-1 treatment, have never taken HIV-1 medicines before, and have an amount of HIV-1 in their blood (“viral load”) that is no more than 100,000 copies/mL; or in 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. ODEFSEY combines 3 medicines into 1 pill taken once a day with a meal. ODEFSEY is a complete HIV-1 treatment and should not be used with other HIV-1 medicines.

Serious side effects of ODEFSEY may also include: • Severe skin rash and allergic reactions. Skin rash is a common side effect of ODEFSEY. Call your healthcare provider right away if you get a rash, as some rashes and allergic reactions may need to be treated in a hospital. Stop taking ODEFSEY and get medical help right away if you get a rash with any of the following symptoms: fever, skin blisters, mouth sores, redness or swelling of the eyes (conjunctivitis), swelling of the face, lips, mouth, or throat, trouble breathing or swallowing, pain on the right side of the stomach (abdominal) area, and/or dark “tea-colored” urine. • Depression or mood changes. Tell your healthcare provider right away if you: feel sad or hopeless, feel anxious or restless, have thoughts of hurting yourself (suicide) or have tried to hurt yourself. • Changes in liver enzymes. People who have had hepatitis B or C or who have certain liver enzyme changes may have a higher risk for new or worse liver problems while taking ODEFSEY. Liver problems can also happen in people who have not had liver disease. Your healthcare provider may do tests to check your liver enzymes before and during treatment with ODEFSEY. • 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 Ƃ IJV KPHGEVKQPU 6GNN [QWT healthcare provider if you have any new symptoms after you start taking ODEFSEY. • Kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys. Your healthcare provider may tell you to stop taking ODEFSEY if you develop new or worse kidney problems. • Bone problems, such as bone pain, softening, or thinning, which may lead to fractures. Your healthcare provider may do tests to check your bones.

ODEFSEY does not cure HIV-1 infection or AIDS. To control HIV-1 infection and decrease HIV-related illnesses, you must keep taking ODEFSEY. 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

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

• Buildup 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; loss of appetite; light-colored bowel movements (stools); nausea; and/or pain, aching, or tenderness on 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 ODEFSEY or a similar medicine 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 virus (HBV) infection. ODEFSEY

is not approved to treat HBV. If you have both HIV-1 and HBV and stop taking ODEFSEY, your HBV may suddenly get worse. &Q PQV UVQR VCMKPI 1&'(5'; YKVJQWV Ƃ TUV VCNMKPI VQ [QWT healthcare provider, as they will need to monitor your health.

Who should not take ODEFSEY? Do not take ODEFSEY if you take: • Certain prescription medicines for other conditions. It is important to ask your healthcare provider or pharmacist about medicines that should not be taken with ODEFSEY. 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 should I tell my healthcare provider before taking ODEFSEY? • All your health problems. Be sure to tell your healthcare

provider if you have or have had any kidney, bone, mental health (depression or suicidal thoughts), or liver problems, including hepatitis virus infection. • All the medicines you take, including prescription and overthe-counter medicines, vitamins, and herbal supplements. Other medicines may affect how ODEFSEY 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 ODEFSEY with all of your other medicines. • If you are pregnant or plan to become pregnant. It is not known if ODEFSEY can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking ODEFSEY. • If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk.

Ask your healthcare provider if ODEFSEY is right for you, and visit ODEFSEY.com to learn more. 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 ODEFSEY including important warnings on the following page.

ODEFSEY does not cure HIV-1 or AIDS.

SHOW YOUR

RADIANCE ODEFSEY is a complete, 1-pill, once-a-day HIV-1 treatment for people 12 years and older who are either new to treatment and have less than 100,000 copies/mL of virus in their blood or people whose healthcare provider determines they can replace their current HIV-1 medicines with ODEFSEY.

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

(oh-DEF-see) MOST IMPORTANT INFORMATION ABOUT ODEFSEY

POSSIBLE SIDE EFFECTS OF ODEFSEY

ODEFSEY may cause serious side effects, including:

ODEFSEY can cause serious side effects, including:

•

Buildup 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; loss of appetite; light-colored bowel movements (stools); nausea; and/ or pain, aching, or tenderness on the right side of your stomach area.

•

Worsening of hepatitis B (HBV) infection. ODEFSEY is not approved to treat HBV. If you have both HIV-1 and HBV, your HBV may suddenly get worse if you stop taking ODEFSEY. Do not stop taking ODEFSEY 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 ODEFSEY or a similar medicine for a long time.

• • • •

• •

Those in the “Most Important Information About ODEFSEY” section. Severe skin rash and allergic reactions. Depression or mood changes. Changes in liver enzymes. Changes in body fat. Changes in your immune system. New or worse kidney problems, including kidney failure. Bone problems.

The most common side effects of rilpivirine, one of the medicines in ODEFSEY, are depression, trouble sleeping (insomnia), and headache. The most common side effect of emtricitabine and tenofovir alafenamide, two of the medicines in ODEFSEY, is nausea. These are not all the possible side effects of ODEFSEY. Tell your healthcare provider right away if you have any new symptoms while taking ODEFSEY. Your healthcare provider will need to do tests to monitor your health before and during treatment with ODEFSEY.

BEFORE TAKING ODEFSEY ABOUT ODEFSEY •

ODEFSEY is a prescription medicine used to treat HIV-1 in people 12 years of age and older who have never taken HIV-1 medicines before and who have an amount of HIV-1 in their blood (“viral load”) that is no more than 100,000 copies/mL. ODEFSEY can also be used to replace current HIV-1 medicines for some people who have an undetectable viral load (less than 50 copies/ mL), have been on the same HIV-1 medicines for at least 6 months, have never failed HIV-1 treatment, and whose healthcare provider determines that they meet certain other requirements.

•

ODEFSEY does not cure HIV-1 or AIDS. Ask your healthcare provider about how to prevent passing HIV-1 to others.

Do NOT take ODEFSEY if you: • Take a medicine that contains: carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®, Tegretol-XR®, Teril®), dexamethasone (Ozurdex®, Maxidex®, Decadron®, Baycadron™), dexlansoprazole (Dexilant®), esomeprazole (Nexium®, Vimovo®), lansoprazole (Prevacid®), omeprazole (Prilosec®, Zegerid®), oxcarbazepine (Trileptal®), pantoprazole sodium (Protonix®), phenobarbital (Luminal®), phenytoin (Dilantin®, Dilantin-125®, Phenytek®), rabeprazole (Aciphex®), rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®), or rifapentine (Priftin®). •

Take the herbal supplement St. John’s wort.

•

Take any other HIV-1 medicines at the same time.

Tell your healthcare provider if you: • Have or have had any kidney, bone, mental health (depression or suicidal thoughts), 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 ODEFSEY.

HOW TO TAKE ODEFSEY • •

ODEFSEY is a complete 1-pill, once-a-day HIV-1 medicine. Take ODEFSEY with a meal.

GET MORE INFORMATION •

• •

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

ODEFSEY, the ODEFSEY Logo, GILEAD, and the GILEAD Logo are trademarks of Gilead Sciences, Inc., or its related companies. All other marks referenced herein are the property of their respective owners. Version date: March 2016 © 2016 Gilead Sciences, Inc. All rights reserved. ODEC0026 06/16

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