The efficacy and safety of DESCOVY to reduce the risk of acquiring HIV-1 infection were evaluated in a randomized, double-blind multinational trial (DISCOVER) in HIV-seronegative men (N=5,262) or transgender women (N=73) who have sex with men and are at risk of HIV-1 infection, comparing once daily DESCOVY (N=2,670) to TRUVADA (FTC/TDF 200 mg/300 mg; N=2,665). Evidence of risk behavior at entry into the trial included at least one of the following: two or more unique condomless anal sex partners in the past 12 weeks or a diagnosis of rectal gonorrhea/chlamydia or syphilis in the past 24 weeks. The median age of participants was 34 years (range, 18-76); 84% were White, 9% Black/Mixed Black, 4% Asian, and 24% Hispanic/Latino. At baseline, 897 participants (17%) reported receiving TRUVADA for PrEP.
At weeks 4, 12, and every 12 weeks thereafter, all participants received local standard of care HIV-1 prevention services, including HIV-1 testing, evaluation of adherence, safety evaluations, risk-reduction counseling, condoms, management of sexually transmitted infections, and assessment of sexual behavior.
Trial participants maintained a high risk of sexual HIV-1 acquisition, with high rates of rectal gonorrhea (DESCOVY, 24%; TRUVADA, 25%), rectal chlamydia (DESCOVY, 30%; TRUVADA, 31%), and syphilis (14% in both treatment groups) during the trial.
The primary outcome was the incidence of documented HIV-1 infection per 100 person-years in participants randomized to DESCOVY and TRUVADA (with a minimum follow-up of 48 weeks and at least 50% of participants having 96 weeks of follow-up). DESCOVY was non-inferior to TRUVADA in reducing the risk of acquiring HIV-1 infection (Table 16). The results were similar across the subgroups of age, race, gender identity, and baseline TRUVADA for PrEP use.
|DESCOVY(N=2,670)||TRUVADA(N=2,665)||Rate Ratio(95% CI)|
|4,370 person-years||4,386 person-years|
|CI = Confidence interval.|
|HIV-1 infections, n||7||15|
|Rate of HIV-1 infections per 100 person-years||0.16||0.34||0.468(0.19, 1.15)|
Of the 22 participants diagnosed with HIV-1 infection in the trial, five had suspected baseline infection prior to study entry (DESCOVY, 1; TRUVADA, 4). In a case-control substudy of intracellular drug levels and estimated number of daily doses as measured by dried blood spot testing, median intracellular tenofovir diphosphate concentrations were substantially lower in participants infected with HIV-1 at the time of diagnosis compared with uninfected matched control participants. For both DESCOVY and TRUVADA, efficacy was therefore strongly correlated to adherence to daily dosing.
DESCOVY tablets are available in bottles and blister packs containing 30 tablets:
- 200 mg/25 mg tablets each contain 200 mg of emtricitabine (FTC) and 25 mg of tenofovir alafenamide (TAF). These tablets are blue, rectangular-shaped, and film-coated with “GSI” debossed on one side and “225” on the other side (NDC 61958-2002-1).
- 120 mg/15 mg tablets each contain 120 mg of FTC and 15 mg of TAF. These tablets are white, round-shaped, and film coated with “GSI” debossed on one side and “15” on the other side (NDC 61958-2005-1).
Bottles contain a silica gel desiccant, polyester coil, and child resistant closure.
Keep bottle tightly closed.
- 200 mg/25 mg tablets each contain 200 mg of FTC and 25 mg of TAF. These tablets are blue, rectangular-shaped, and film-coated with “GSI” debossed on one side and “225” on the other side (NDC 61958-2002-2).
Blister packs are sealed with a child-resistant laminated foil lidding material (peel-push) and each blister cavity contains a die-cut desiccant film which is heat staked to the foil lidding material.
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).
Dispense only in original container.
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Important Information for Uninfected Individuals Taking DESCOVY for HIV-1 PrEP
Advise HIV-1 uninfected individuals about the following [see Warnings and Precautions (5.2)]:
- The need to confirm that they are HIV-negative before starting to take DESCOVY to reduce the risk of acquiring HIV-1.
- That HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking DESCOVY, because DESCOVY alone does not constitute a complete regimen for HIV-1 treatment.
- The importance of taking DESCOVY on a regular dosing schedule and strict adherence to the recommended dosing schedule to reduce the risk of acquiring HIV-1. Uninfected individuals who miss doses are at greater risk of acquiring HIV-1 than those who do not miss doses.
- That DESCOVY does not prevent other sexually acquired infections and should be used as part of a complete prevention strategy including other prevention measures.
- To use condoms consistently and correctly to lower the chances of sexual contact with any body fluids such as semen, vaginal secretions, or blood.
- The importance of knowing their HIV-1 status and the HIV-1 status of their partner(s).
- The importance of virologic suppression in their partner(s) with HIV-1.
- The need to get tested regularly for HIV-1 (at least every 3 months, or more frequently for some individuals such as adolescents) and to ask their partner(s) to get tested as well.
- To report any symptoms of acute HIV-1 infection (flu-like symptoms) to their healthcare provider immediately.
- That the signs and symptoms of acute infection include fever, headache, fatigue, arthralgia, vomiting, myalgia, diarrhea, pharyngitis, rash, night sweats, and adenopathy (cervical and inguinal).
- To get tested for other sexually transmitted infections, such as syphilis, chlamydia, and gonorrhea, that may facilitate HIV-1 transmission.
- To assess their sexual risk behavior and get support to help reduce sexual risk behavior.
Post-treatment Acute Exacerbation of Hepatitis B in Patients with HBV Infection
Inform individuals that severe acute exacerbations of hepatitis B have been reported in patients who are infected with HBV and have discontinued products containing FTC and/or TDF and may likewise occur with discontinuation of DESCOVY [see Warnings and Precautions (5.1)]. Advise HBV-infected individuals to not discontinue DESCOVY without first informing their healthcare provider.
Immune Reconstitution Syndrome
Advise HIV-1 infected patients to inform their healthcare provider immediately of any symptoms of infection. In some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started [see Warnings and Precautions (5.3)].
New Onset or Worsening Renal Impairment
Advise HIV-1 infected patients and uninfected individuals to avoid taking DESCOVY with concurrent or recent use of nephrotoxic agents. Postmarketing cases of renal impairment, including acute renal failure, have been reported [see Warnings and Precautions (5.4)].
Lactic Acidosis and Severe Hepatomegaly
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with use of drugs similar to DESCOVY. Advise HIV-1 infected patients and uninfected individuals that they should stop DESCOVY if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity [see Warnings and Precautions (5.5)].
Dosage Recommendations for Treatment of HIV-1 Infection
Inform HIV-1 infected patients that it is important to take DESCOVY with other antiretroviral drugs for the treatment of HIV-1 on a regular dosing schedule with or without food and to avoid missing doses as it can result in development of resistance [see Dosage and Administration (2.3, 2.4)].
Inform individuals using DESCOVY that there is an antiretroviral pregnancy registry to monitor fetal outcomes of pregnant women exposed to DESCOVY [see Use in Specific Populations (8.1)].
Instruct mothers with HIV-1 infection not to breastfeed because of the risk of passing the HIV-1 virus to the baby [see Use in Specific Populations (8.2)].
DESCOVY and TRUVADA are trademarks of Gilead Sciences, Inc., or its related companies. All other trademarks referenced herein are the property of their respective owners.
© 2022 Gilead Sciences, Inc. All rights reserved.
|This Medication Guide has been approved by the U.S. Food and Drug Administration||Revised: 01/2022|
|Medication GuideDESCOVY® (des-KOH-vee)(emtricitabine and tenofovir alafenamide)tablets|
|Read this Medication Guide before you start taking DESCOVY and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. This Medication Guide provides information about two different ways that DESCOVY may be used. See the section “What is DESCOVY?“ for detailed information about how DESCOVY may be used.|
| What is the most important information I should know about DESCOVY?DESCOVY can cause serious side effects, including: |
| || |
| While you are taking DESCOVY for HIV-1 PrEP: |
|What is DESCOVY?DESCOVY is a prescription medicine that may be used in two different ways. DESCOVY is used: |
|For people taking DESCOVY for HIV-1 PrEP:Do not take DESCOVY for HIV-1 PrEP if: |
|What should I tell my healthcare provider before taking DESCOVY?Before taking DESCOVY, tell your healthcare provider about all of your medical conditions, including if you: |
| How should I take DESCOVY? |
|What are the possible side effects of DESCOVY?DESCOVY may cause serious side effects, including: |
| How should I store DESCOVY? |
|General information about the safe and effective use of DESCOVY. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use DESCOVY for a condition for which it was not prescribed. Do not give DESCOVY to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about DESCOVY that is written for health professionals.|
|What are the ingredients in DESCOVY?Active ingredients: emtricitabine and tenofovir alafenamide.Inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The 200 mg/25 mg tablets are film-coated with a coating material containing indigo carmine aluminum lake, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. The 120 mg/15 mg tablets are film-coated with a coating material containing polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Manufactured and distributed by: Gilead Sciences, Inc. Foster City, CA 94404DESCOVY is a trademark of Gilead Sciences, Inc., or its related companies. All other trademarks referenced herein are the property of their respective owners.© 2022 Gilead Sciences, Inc. All rights reserved.208215-GS-009For more information, call 1-800-445-3235 or go to www.DESCOVY.com.|
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