POZ July/August 2016

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

© Janssen Therapeutics, Division of Janssen Products, LP 2016 05/16 051975-160425

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

}

“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

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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. ¶

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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

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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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MILESTONES IN THE ERA OF EFFECTIVE HIV TREATMENT

The first HIV med, Retrovir (zidovudine, or AZT), was approved in 1987. Over the next few years, additional antiretrovir also known as NRTIs, or nukes). But using only one or two meds from the same drug class wasn’t enough to fully suppre inhibitor (PI), Invirase (saquinavir), was approved, and a new era of combination therapy was set to begin. Here’s a time

The first nonnucleoside reverse transcriptase inhibitor (NNRTI, or non-nuke), Viramune (nevirapine), is approved.

In an about-face, U.S. treatment guidelines switch to recommending starting ARVs when CD4s have dropped to 200 or below.

The first onc single-tab regimen, (efaviren emtricitab ap

The Global Fund to Fight AIDS, Tuberculosis and Malaria in developing nations is launched.

The first entry inhibitor, the injectable Fuzeon (enfuvirtide), is approved.

Norvir (ritonavir), a PI that would become a booster of other ARVs, is approved.

At the 11th International AIDS Conference in Vancouver, numerous studies demonstrate the efficacy of triple-combination antiretroviral (ARV) treatment, ushering in the era of what was then called highly active antiretroviral treatment, or HAART.

The U.S. Department of Health and Human Services issues the first federal HIV treatment guidelines, recommending treatment for those with fewer than 500 CD4s, in keeping with the “hit early, hit hard” philosophy of the time.

Viread (tenofovir disoproxil fumarate, or TDF), which comes with bone and kidney toxicities, is approved and goes on to become the most widely prescribed ARV.

2003

2002

2001

2000

1999

1998

1997

1996 19 996

AIDS-related deaths drop 47 percent in one year.

President George W. Bush launches the U.S. President’s Emergency Plan for AIDS Relief, or PEPFAR, pledging to spend $15 billion to combat the disease in poorer nations in five years.

2005

The first combination ARV tablet, Combivir (zidovudine/ lamivudine), is approved.

2004

The first viral load test is approved.

The SMART trial is s early. The expansive study investigated w interrupting HIV trea could reduce the diseases thought to result of ARV tox But those who inter treatment actua worse health out The surprise fi spur research i link between HIV, inflammation and non defining con such a d

T

stopped e global whether atment e risk of o be the xicities. rrupted ally had tcomes. findings into the chronic n-AIDSnditions as heart disease.

U.S. guidelines recommend treatment for all people living with HIV, regardless of their CD4 count.

WHO recommends treatment once CD4s hit 500 or below.

The HPTN 052 study finds that starting ARVs reduces the risk of transmitting HIV through heterosexual sex by 96 percent, launching the treatment-as-prevention (TasP) era.

(T

The first oral entry inhibitor, Selzentry (maraviroc), is approved.

UNAIDS reports that global AIDSrelated deaths have fallen 30 percent since peaking in 2005.

2014

2012

2009

2008

2007

2006

As HIV treatments improve, U.S. treatment guidelines up the CD4 threshold for starting ARVs to 350.

2011

As San Francisco recommends HIV treatment regardless of CD4 count, U.S. guidelines advise starting ARVs when CD4s drop to 500, while the threshold set by the World Health Organization (WHO) is 350 CD4s.

2013

The first integrase inhibitor, Isentress (raltegravir), is approved.

2010

ce-daily, blet ARV , Atripla nz/TDF/ bine), is pproved.

The placebo arm of the global START trial is terminated early when it becomes clear that there is a lower risk of various negative health outcomes associated with starting ARVs when CD4s are above 500 compared with waiting until they hit 350.

In response, WHO supports treatment for all, regardless of CD4 count.

2015

rals (ARVs) were introduced in the same drug class (nucleoside reverse transcriptase inhibitors, ess the virus, and the crisis period of the epidemic raged on. In December 1995, the first protease eline of the highlights:

The FDA FD approves approve ap Truvada Truv Tr uvad ada (TDF/ (TD emtricitabine) emtr em tric i itabin for fo use as a pre-exposure pre-ex prepr exposu prophylaxis prop pr ophy hylax (PrEP).

(PrEP (P

Interim results from the ongoing PARTNER study find that there have been no transmissions between partners in gay or straight mixed-HIV-status couples in which the HIV-positive partner has an pa undetectable u viral load.

Researchers estimate that e the actual ttransmission risk may be close to zero, or in fact zero.

Genvoya Gen (elvitegravir/ (elv cobicistat/ cob co emtricitabine/ emt em tenofovir teno te alafenamide, alaf TAF) is the or T first approved combination tablet to include an updated version of tenofovir that is safer for bones and kidneys.

ALL IMAGES: ISTOCK (MODELS USED FOR ILLUSTRATIVE PURPOSES ONLY)

YOU DESERVE

ANSWERS

HOW DO WE HEL A. PREVENT IT. B. TEST FOR IT. C. TREAT IT. D. ALL OF THE AB

HIV Answers gives you the information you want, privately, right on your phone.

Get started online at

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Learn how it all works together at HelpStopTheVirus.com

© 2016 Gilead Sciences, Inc. All rights reserved. UNBC3323 05

LP STOP HIV?

TREATMENT LOWERS THE AMOUNT OF HIV IN YOUR BODY. AND HELPS LOWER THE CHANCE OF PASSING HIV ON.

BOVE.

5/16

There is no cure for HIV, but treatment can help protect your health and the people you care about. Talk to a healthcare provider and visit HelpStopTheVirus.com © 2016 Gilead Sciences, Inc. All rights reserved. UNBC3321 05/16

Antiretroviral (ARV) options abound for both those who are new to HIV treatment and those who are experienced. This quick-reference chart compares available medication options, including adult dosing and dietary restrictions. &

H I V

*Generic version available in the U.S.

COMBIVIR *

APTIVUS

(zidovudine + lamivudine)

ATRIPLA

(efavirenz + tenofovir disoproxil + emtricitabine)

(tenofovir alafenamide + emtricitabine)

CRIXIVAN (indinavir)

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

GENVOYA

Single-Tablet Regimens

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

ODEFSEY

(rilpivirine + tenofovir alafenamide + emtricitabine) One tablet once a day. Each tablet contains 25 mg rilpivirine + 25 mg tenofovir alafenamide + 200 mg emtricitabine.

Take with a meal.

STRIBILD

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

Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs, or nukes)

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

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

EPIVIR *

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

Protease Inhibitors (PIs)

COMPLERA

EMTRIVA

Two 400 mg capsules every eight hours, or two 400 mg capsules with either one or two 100 mg Norvir tablets (or capsules) twice a day. Drink at least 48 ounces of water daily to prevent kidney stones.

Without Norvir: Take on an empty stomach (no food two hours before or one hour after dosing) or with a light, low-fat snack.

With Norvir: Take with or without food.

EVOTAZ

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

INVIRASE

(saquinavir)

EPZICOM

(abacavir + lamivudine) One tablet once a day. Each tablet contains 600 mg abacavir + 300 mg lamivudine. Take with or without food.

Should be used only by individuals who are HLA-B*5701 negative.

(rilpivirine)

Two 250 mg capsules plus two 100 mg Norvir tablets (or capsules) twice a day.

Aptivus plus Norvir should be taken with food. Aptivus plus Norvir should not be taken with other protease inhibitors.

DESCOVY

(rilpivirine + tenofovir disoproxil + emtricitabine)

EDURANT

(tipranavir)

One tablet twice a day. Each tablet contains 300 mg zidovudine + 150 mg lamivudine. Take with or without food.

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

Pills not shown actual size

Two 500 mg tablets plus one 100 mg Norvir tablet (or capsule) twice a day. Take with food or within two hours after a meal.

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

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

L I F E

(zidovudine)

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

TRIZIVIR

(abacavir + zidovudine + lamivudine) One tablet twice a day. Each tablet contains 300 mg abacavir + 300 mg zidovudine + 150 mg lamivudine. Take with or without food. Should be used only by individuals who are HLA-B*5701 negative.

(etravirine)

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

RESCRIPTOR (delavirdine)

Two 200 mg tablets three times a day, or four 100 mg tablets three times a day.

Take with or without food.

SUSTIVA

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

(nevirapine)

One 200 mg Viramune immediate release (IR) tablet once a day for the first 14 days, then one 400 mg Viramune extended release (XR) tablet once a day. Take with or without food.

KALETRA

(lopinavir + ritonavir)

RETROVIR *

INTELENCE

VIRAMUNE *

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

LEXIVA

(fosamprenavir) Two 700 mg tablets twice a day, or two 700 mg tablets plus one or two Norvir tablets once a day, or one 700 mg tablet plus one Norvir tablet twice a day (recommended for individuals who have used other PIs in the past). Take with or without food.

Entry Inhibitors

H E A L T H ,

FUZEON

(enfuvirtide) One 90 mg (1 ml solution) subcutaneous injection twice a day. Take with or without food. Fuzeon comes as a white powder that must be mixed with sterile water in a vial each day.

Integrase Inhibitors

(raltegravir)

One 400 mg tablet twice a day. Take with or without food.

TIVICAY

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

Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs, or nukes)

ISENTRESS

VIDEX EC *

(didanosine) One 400 mg capsule once a day. (One 250 mg capsule once a day for those weighing less than 133 lbs.) Take on an empty stomach (two hours after or one hour before a meal). Videx EC should be taken with water. It should not be taken with acidic juices, soda or milk. Videx EC should be taken at least two hours after or two hours before Aptivus or Reyataz. Avoid alcohol.

Six 100 mg tablets twice a day. The full dose of Norvir is rarely used. It is most often used at lower doses to boost the levels of other ARVs in the blood. Take with food.

PREZCOBIX

(darunavir + cobicistat) One tablet once a day. Each tablet contains 800 mg darunavir + 150 mg cobicistat.

Take with food.

PREZISTA (darunavir)

VIREAD

(tenofovir disoproxil) One 300 mg tablet once a day. Take with or without food.

ZERIT *

(stavudine) One 40 mg capsule twice a day. (One 30 mg capsule twice a day for those weighing less than 133 lbs.) Take with or without food.

One 800 mg tablet (or two 400 mg tablets) plus one 100 mg Norvir tablet or one 150 mg Tybost tablet once a day, or one 600 mg tablet plus one 100 mg Norvir tablet twice a day, depending on drug resistance. Take with food.

REYATAZ

(atazanavir) Two 200 mg capsules once a day, or one 300 mg capsule plus one 100 mg Norvir tablet or one 150 mg Tybost tablet once a day. Take with food.

VITEKTA

(elvitegravir) One 85 mg tablet once a day when taken with twice-daily Kaletra or once-daily Reyataz plus Norvir. One 150 mg tablet once a day when taken with twice-daily Lexiva plus Norvir, Prezista plus Norvir, or Aptivus plus Norvir. Take with food.

ZIAGEN * (abacavir)

VIRACEPT

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

Two 625 mg tablets twice a day, or five 250 mg tablets twice a day, or three 250 mg tablets three times a day. Take with food.

(nelfinavir)

Entry Inhibitors

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

(ritonavir)

Protease Inhibitors (PIs)

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

NORVIR

(tenofovir disoproxil + emtricitabine)

TRIUMEQ

PK Enhancer

TRUVADA

SELZENTRY (maraviroc)

One 150 mg, 300 mg or 600 mg tablet twice a day, depending on other meds used. Take with or without food.

TYBOST

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

When choosing your HIV regimen, be sure to ask your doctor about: Potency: Is the combo powerful enough to keep my viral load undetectable?

Safety: What are the short- and long-term side effects of the meds?

Convenience: How many pills must I take and how many times a day?

Interactions: How do the meds work with other drugs I’m taking?

To learn more about these medications, including possible side effects and drug interactions, visit POZ.com.

Brief Summary of Patient Information about ODEFSEY ODEFSEY (oh-DEF-see) (emtricitabine, rilpivirine and tenofovir alafenamide) tablets Important: Ask your healthcare provider or pharmacist about medicines that should not be taken with ODEFSEY. There may be new information about ODEFSEY. This information is only a summary and 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 ODEFSEY? ODEFSEY can cause serious side effects, including: • Build-up of lactic acid in your blood (lactic acidosis). Lactic acidosis may happen in some people who take ODEFSEY or similar medicines. Lactic acidosis is a serious medical emergency that can lead to death. Lactic acidosis can be hard to identify early, because the symptoms could seem like symptoms of other health problems.

Call your healthcare provider right away if you get any of the following symptoms which could be signs of lactic acidosis: – feel very weak or tired – have unusual (not normal) muscle pain – have trouble breathing – have stomach pain with nausea or vomiting – feel cold, especially in your arms and legs – feel dizzy or lightheaded – have a fast or irregular heartbeat • Severe liver problems. Severe liver problems may happen in people who take ODEFSEY. In some cases, these liver problems can lead to death. Your liver may become large and you may develop fat in your liver.

Call your healthcare provider right away if you get any of the following symptoms of liver problems: – 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 – pain, aching, or tenderness on the right side of your stomach area • You may be more likely to get lactic acidosis or severe liver problems if you are female, very overweight (obese), or have been taking ODEFSEY or a similar medicine for a long time.

• Worsening of Hepatitis B virus (HBV) infection. ODEFSEY is not approved to treat HBV. If you have HBV and take ODEFSEY, your HBV may get worse (flare-up) if you stop taking ODEFSEY. A “flare-up” is when your HBV infection suddenly returns in a worse way than before.

– Do not run out of ODEFSEY. Refill your prescription or talk to your healthcare provider before your ODEFSEY is all gone.

– Do not stop taking ODEFSEY without first talking to your healthcare provider.

– If you stop taking ODEFSEY, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking ODEFSEY.

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What is ODEFSEY? ODEFSEY is a prescription medicine that is used to treat HIV-1 in people 12 years of age and older: • who have not received HIV-1 medicines in the past and have an amount of HIV-1 in their blood (“viral load”) that is no more than 100,000 copies/mL, or • to replace their current HIV-1 medicines in people who have been on the same HIV-1 medicines for at least 6 months, have a viral load that is less than 50 copies/mL, and have never failed past HIV-1 treatment.

It is not known if ODEFSEY is safe and effective in children under 12 years of age or who weigh less than 77 lb (35 kg).

When used to treat HIV-1 infection, ODEFSEY 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).

ODEFSEY 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.

Ask your healthcare provider about how to prevent passing HIV-1 to others. Do not share or re-use needles, injection equipment, or personal items that can have blood or body fluids on them. Do not have sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.

Who should not take ODEFSEY? Do not take ODEFSEY if you also take a medicine that contains: • carbamazepine (Carbatrol®, Epitol®, Equetro ®, Tegretol®, Tegretol-XR®, Teril®) • dexamethasone (Ozurdex®, Maxidex®, Decadron®, BaycadronTM) • 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®) • rifapentine (Priftin®) • the herb St. John’s wort or a product that contains St. John’s wort

What should I tell my healthcare provider before taking ODEFSEY? Before taking ODEFSEY, tell your healthcare provider if you: • have liver problems including hepatitis B or C virus infection • have kidney and bone problems • have had depression or suicidal thoughts • have any other medical conditions • 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.

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Pregnancy registry: there is a pregnancy registry for women who take HIV-1 medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.

• are breastfeeding or plan to breastfeed. Do not breastfeed if you take ODEFSEY. – You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.

– At least one of the medicines in ODEFSEY can pass to your baby in your breast milk. It is not known if the other medicines in ODEFSEY can pass into your breast milk.

– Talk with 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 may interact with ODEFSEY. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

• You can ask your healthcare provider or pharmacist for a list of medicines that interact with ODEFSEY. • Do not start a new medicine without telling your healthcare provider.

Your healthcare provider can tell you if it is safe to take ODEFSEY with other medicines.

How should I take ODEFSEY? • Take ODEFSEY exactly as your healthcare provider tells you to take

• •

• • •

it. ODEFSEY is taken by itself (not with other HIV-1 medicines) to treat HIV-1 infection.

Take ODEFSEY 1 time each day with a meal.

Do not change your dose or stop taking ODEFSEY without first talking with your healthcare provider. Stay under a healthcare provider’s care when taking ODEFSEY. Do not miss a dose of ODEFSEY. If you take too much ODEFSEY, call your healthcare provider or go to the nearest hospital emergency room right away.

When your ODEFSEY supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to ODEFSEY and become harder to treat.

What are the possible side effects of ODEFSEY? ODEFSEY may cause serious side effects, including: • See “What is the most important information I should know about ODEFSEY?” • Severe skin rash and allergic reactions. Skin rash is a common side effect of ODEFSEY. Rash can be serious. Call your healthcare provider right away if you get a rash. In some cases, rash and allergic reaction may need to be treated in a hospital. If you get a rash with any of the following symptoms, stop taking ODEFSEY and call your healthcare provider right away: – 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 – dark “tea-colored” urine

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• Depression or mood changes. Tell your healthcare provider right

away if you have any of the following symptoms: – feel sad or hopeless – feel anxious or restless – have thoughts of hurting yourself (suicide) or have tried to hurt yourself • Change in liver enzymes. People with a history of hepatitis B or C virus infection or who have certain liver enzyme changes may have an increased risk of developing new or worsening liver problems during treatment with ODEFSEY. Liver problems can also happen during treatment with ODEFSEY in people without a history of liver disease. Your healthcare provider may need to do tests to check your liver enzymes before and during treatment with ODEFSEY. • Changes in body fat can happen in people who take HIV-1 medicine. These changes may include 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 any new symptoms after starting your HIV-1 medicine.

• New or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys before you start and while you are taking ODEFSEY. Your healthcare provider may tell you to stop taking ODEFSEY if you develop new or worse kidney problems.

• Bone problems can happen in some people who take ODEFSEY. Bone problems may include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do tests to check your bones.

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.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

• These are not all the possible side effects of ODEFSEY. For more information, ask your healthcare provider or pharmacist.

• Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This Brief Summary summarizes the most important information about ODEFSEY. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ODEFSEY that is written for health professionals.

For more information, call 1-800-445-3235 or go to www.ODEFSEY.com.

Keep ODEFSEY and all medicines out of reach of children.

Issued: March 2016

ODEFSEY, the ODEFSEY logo, EMTRIVA, GILEAD, the GILEAD Logo, and GSI are trademarks of Gilead Sciences, Inc., or its related companies. All other trademarks referenced herein are the property of their respective owners. © 2016 Gilead Sciences, Inc. All rights reserved. GILC0216 03/16

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New Odefsey is now available Actual Size (15.4 mm x 7.3 mm)

One small pill contains rilpivirine, emtricitabine, and tenofovir alafenamide (TAF).

Ask your healthcare provider if ODEFSEY is right for you.

To learn more visit ODEFSEY.com

Please see Brief Summary of Patient Information with important warnings on the adjacent pages.

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