Descovy

Descovy is used to treat and prevent HIV infection in adults and adolescents. When used for HIV-1 treatment, it is taken with other antivirals. When used to prevent HIV-1 infection, it is called Descovy PrEP, and it is the only tablet needed to prevent HIV.

Descovy contains 2 antivirals, emtricitabine and tenofovir alafenamide, combined in 1 tablet and taken once a day.

Descovy gained FDA approval on April 4, 2016, for the treatment of HIV-1, and this was extended on October 3, 2019, to include HIV PrEP.

Approval for HIV PrEP was primarily based on the DISCOVER trial (NCT02842086, n=5387), which showed Descovy (F/TAF) was non-inferior to Truvada (F/TDF) with 53% fewer HIV infections and better renal and bone safety.

Descovy for HIV-1 infection:

• In adults and children who weigh at least 77 pounds (35 kg), together with other HIV-1 medicines
• In children who weigh at least 31 pounds (14 kg) and less than 77 pounds (35 kg), together with certain other HIV-1 medicines (not some protease inhibitors). Your healthcare provider will determine which other HIV-1 medicines may be used with Descovy.

Descovy for PrEP:

• To reduce the risk of getting HIV-1 infection in adults and adolescents who weigh at least 77 pounds (35 kg). It is not known if Descovy is effective in reducing the risk of getting HIV-1 from certain types of sex.

Important: Descovy for PrEP is not for use in people born female (assigned female at birth) who are at risk of getting HIV-1 infection from vaginal sex, because its effectiveness has not been studied.

Take Descovy exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

• Take one dose daily.
• Take with or without food.
• For dialysis patients: Take after dialysis.
• Never skip doses or stop treatment without medical advice.
• Maintain an adequate supply. Do not run out of medicine because it may increase your risk of infection from HIV and other viruses.

Descovy PrEP does not prevent other sexually transmitted infections (STIs).

• Practice safer sex by using a latex or polyurethane condom to reduce the risk of getting STIs.
• You must stay HIV-1 negative to keep taking Descovy for HIV-1 PrEP.
• Get tested for other STIs such as syphilis, chlamydia, and gonorrhea. These infections make it easier for HIV-1 to infect you.

Before taking Descovy, tell your healthcare provider about all of your medical conditions, including if you:

• have any flu-like symptoms
• have liver problems, including HBV infection
• have kidney problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

For people taking Descovy for PrEP

Do not take Descovy for PrEP if you already have an HIV-1 infection or do not know your HIV status. If you are HIV-1 positive, you need to take other medicines with Descovy to treat HIV-1. Descovy by itself is not a complete treatment for HIV-1. Before Starting Descovy for PrEP

• You must confirm you are HIV-negative through testing
• Get tested for hepatitis B (HBV)
• Inform your healthcare provider about any flu-like symptoms within the last month
• Discuss all existing medical conditions and medications.

To ensure Descovy for PrEP remains effective, you must:

• Maintain regular HIV testing (at least every 3 months)
• Practice safer sex using latex or polyurethane condoms
• Get regular STI testing
• Never miss a dose
• Know your partner's HIV status
• Report any potential HIV exposure immediately.

Pregnancy

It is not known if Descovy can harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with Descovy.

Pregnancy Registry: There is a pregnancy registry for people who take Descovy during pregnancy. The purpose of this registry is to collect information about your health and that of your baby. Talk with your healthcare provider about how you can take part in this registry.

Breastfeeding

Descovy passes to your baby in your breast milk. Talk to your healthcare provider about the following risks to your baby from breastfeeding during treatment with Descovy:

• The HIV-1 virus may pass to your baby if your baby does not have HIV-1.
• The HIV-1 virus may become harder to treat if your baby has HIV-1.
• Your baby may get side effects from Descovy

Side effects are similar between Descovy for PrEP and Descovy for HIV treatment, since the medication and dosing are the same.

Warnings

Descovy carries a Boxed Warning for post-treatment worsening of hepatitis B virus (HBV) and the risk of drug resistance with the use of Descovy for PrEP in undiagnosed early HIV-1 infection.

Worsening of Hepatitis B Virus (HBV)

Your healthcare provider will test you for HBV before or when you start treatment with Descovy. If you have HBV and take Descovy, your HBV may get worse (flare-up) if you stop taking Descovy. A “flare-up” is when your HBV suddenly returns in a worse way than before.

• Do not run out of Descovy. Refill your prescription or talk to your healthcare provider before your Descovy is all gone.
• Do not stop taking Descovy without first talking to your healthcare provider.
• If you stop taking Descovy, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver, and may give you a medicine to treat hepatitis B. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking Descovy.

Descovy for PrEP and risk of drug resistance

Before taking Descovy for PrEP to reduce your risk of getting HIV-1:

• You must be HIV-1 negative to start Descovy. You must get tested to make sure that you do not already have HIV-1.
• Do not take Descovy for HIV-1 PrEP unless you are confirmed to be HIV-1 negative.
• Some HIV-1 tests can miss HIV-1 in a person who has recently become infected. If you have flu-like symptoms, you could have recently become infected with HIV-1. Tell your healthcare provider if you had a flu-like illness within the last month before starting Descovy or at any time while taking Descovy. Symptoms of new HIV-1 include: Tiredness Fever Joint or muscle aches Headache Sore throat Vomiting or diarrhea Rash Night sweats Enlarged lymph nodes in the neck or groin.

While taking Descovy for PrEP:

• Descovy does not prevent other sexually transmitted infections (STIs). Practice safer sex by using a latex or polyurethane condom to reduce the risk of getting STIs.
• You must stay HIV-1 negative to keep taking Descovy for HIV-1 PrEP.
• Know your HIV-1 status and the HIV-1 status of your partners.
• Ask your partners with HIV-1 if they are taking HIV-1 medicines and have an undetectable viral load. An undetectable viral load is when the amount of virus in the blood is too low to be measured in a lab test. To maintain an undetectable viral load, your partners must keep taking HIV-1 medicines every day. Your risk of getting HIV-1 is lower if your partners with HIV-1 are taking effective treatment.
• Get tested for HIV-1 at least every 3 months or when your healthcare provider tells you.
• Get tested for other STIs such as syphilis, chlamydia, and gonorrhea. These infections make it easier for HIV-1 to infect you.
• If you think you were exposed to HIV-1, tell your healthcare provider right away. They may want to do more tests to be sure you are still HIV-1 negative.
• Get information and support to help reduce sexual risk behaviors.
• Do not miss any doses of Descovy. Missing doses increases your risk of getting HIV-1.

If you do become HIV-1 positive, you need more medicine than Descovy alone to treat HIV-1. Descovy by itself is not a complete treatment for HIV-1.

If you have HIV-1 and take only Descovy, over time, your HIV-1 may become harder to treat.

Common side effects

The most common side effects of Descovy for:

• The treatment of HIV-1 is nausea
• HIV-1 PrEP is diarrhea.

The most common side effects of Descovy are:

• Diarrhea
• Nausea
• Headache
• Fatigue
• Stomach discomfort.

Serious side effects and warnings

Descovy may cause the following other serious side effects when used for HIV PrEP or HIV-1 treatment.

Changes in Your Immune System (Immune Reconstitution Syndrome)

Changes in your immune system can happen when you start taking medicines to treat HIV-1. Your immune system may become 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 have any new symptoms of infection after starting your HIV-1 medicine.

New or Worse Kidney Problems, Including Kidney Failure

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

Too Much Lactic Acid in Your Blood (Lactic Acidosis)

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

Severe Liver Problems

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

Notes:

Do not take Descovy if you also take other medicines that contain emtricitabine, tenofovir, lamivudine, or adefovir.

Get emergency medical help if you have signs of an allergic reaction to Descovy: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

These are not all of the possible side effects of Descovy.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The two antivirals in Descovy, emtricitabine and tenofovir alafenamide, work by blocking the activity of reverse transcriptase, an enzyme produced by the human immunodeficiency virus that allows it to infect cells and replicate (make more viruses). Emtricitabine and tenofovir alafenamide both belong to the drug class called nucleoside reverse transcriptase inhibitors (NRTIs).

• When Descovy is used to treat HIV-1 infection, the combination of emtricitabine and tenofovir alafenamide reduces the amount of HIV in the blood and keeps it at a low level. Descovy for HIV treatment is always given in combination with at least one other HIV-1 medicine.
• When Descovy is used for PrEP, the combination of emtricitabine and tenofovir alafenamide prevents the HIV-1 virus from multiplying and spreading from the site of infection if a person is exposed to the virus.

Dose of Descovy for PrEP

• Adults and children ≥ 35 kg (77 lb): 200 mg/25 mg (1 tablet) once daily.

Dose of Descovy for HIV-1 Treatment

Use with other antivirals.

• Adults and children ≥ 35 kg (77 lb): 200 mg/25 mg (1 tablet) once daily
• Children at least 25 to 35 kg (55 lb to 77 lb): 200 mg/25 mg (1 tablet) once daily
• Children at least 14 to 25 kg (30.8lb to 55 lb): 120 mg/15 mg (1 tablet) once daily.

Important Note for Pediatric Patients: Descovy with atazanavir/cobicistat (ATV+COBI) is not recommended in pediatric patients weighing 14-35 kg due to excessive TAF exposure (2-5 times higher than adults) observed in Study 128, with limited safety data to support these levels.

The safety and effectiveness of ritonavir-boosted protease inhibitors have also not been established in this weight group.

The safety and effectiveness of Descovy for HIV-1 treatment have not been established in pediatric patients weighing <14 kg.

When taking Descovy for PrEP, the time to reach maximum protection varies depending on your risk factors.

For Receptive Anal Sex

• Takes 7 days of daily use before Descovy protects against HIV-1
• Must take one pill every day
• Provides over 99% protection when used consistently

For Receptive Vaginal Sex

• Takes 21 days of daily use before Descovy protects against HIV-1
• Requires strict daily adherence
• Over 99% effective with daily use

For Injection Drug Use

• Takes 21 days to reach maximum protection
• Reduces HIV risk by at least 74%
• Must be taken every day

Important Notes:

• Effectiveness depends on taking Descovy every day without missing doses
• Protection levels are based on consistent, daily use
• Starting PrEP requires a negative HIV test and ongoing monitoring
• Must be combined with other safer sex practices

Currently Unknown Factors:

The following is not known:

• Time to reach protection for insertive anal sex
• Time to reach protection for insertive vaginal sex.

Always consult your healthcare provider about your specific situation and risk factors.

Take the medicine as soon as you remember, and then go back to your regular schedule. Do not use two doses at one time.

Skipping doses could make the virus resistant to medication or increase your risk of becoming infected with HIV.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Emtricitabine and tenofovir can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Tell your doctor about all your other medicines, especially:

• seizure medicine - carbamazepine, oxcarbazepine, phenytoin, phenobarbital; or
• other antiviral medicine to treat hepatitis C or HIV.

No clinically significant drug interactions have been either observed or are expected when Descovy is combined with atazanavir with ritonavir, atazanavir with cobicistat (in those weighing greater than or equal to 35 kg), darunavir with ritonavir or cobicistat, dolutegravir, efavirenz, ledipasvir, lopinavir/ritonavir, maraviroc, nevirapine, raltegravir, rilpivirine, and sofosbuvir.

This list is not complete, and other drugs may interact with emtricitabine and tenofovir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

• Store at room temperature.
• Keep in their original container.

Descovy is manufactured and distributed by Gilead Sciences, Inc., a biopharmaceutical company based in Foster City, California.

Active ingredients: emtricitabine and tenofovir alafenamide.Inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose.

Film-coating

200 mg/25 mg tablets: Indigo carmine aluminum lake, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

120 mg/15 mg tablets: Polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc.

Availability

• 120 mg/15 mg (emtricitabine 120 mg and tenofovir alafenamide 15 mg)
• 200 mg/25 mg (emtricitabine 200 mg and tenofovir alafenamide 25 mg).