Dosage & Administration
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Descovy for PrEP Prescribing Information
All individuals should be tested for the presence of hepatitis B virus (HBV) before or when initiating DESCOVY
Severe acute exacerbations of hepatitis B (e.g., liver decompensation and liver failure) have been reported in individuals with HBV who have discontinued products containing FTC and/or tenofovir disoproxil fumarate (TDF) and may occur with discontinuation of DESCOVY. Individuals with HBV who discontinue DESCOVY should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. If appropriate, anti-hepatitis B therapy may be warranted, especially in individuals with advanced liver disease or cirrhosis, since post-treatment exacerbation of hepatitis may lead to hepatic decompensation and liver failure. Individuals without HBV should be offered vaccination.
Use DESCOVY for HIV-1 PrEP to reduce the risk of HIV-1 infection as part of a comprehensive prevention strategy, including adherence to daily administration and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). The time from initiation of DESCOVY for HIV-1 PrEP to maximal protection against HIV-1 infection is unknown.
Risk for HIV-1 acquisition includes behavioral, biological, or epidemiologic factors including but not limited to condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence area or network.
Counsel individuals on the use of other prevention measures (e.g., consistent and correct condom use, knowledge of partner(s)’ HIV-1 status, including viral suppression status, regular testing for STIs that can facilitate HIV-1 transmission). Inform individuals without HIV-1 about, and support their efforts in, reducing sexual risk behavior
Use DESCOVY to reduce the risk of acquiring HIV-1 only in individuals confirmed to be HIV-1 negative. HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking only DESCOVY, because DESCOVY alone does not constitute a complete regimen for HIV-1 treatment
- Some HIV-1 tests only detect anti-HIV antibodies and may not identify HIV-1 during the acute stage of infection. Prior to initiating DESCOVY for HIV-1 PrEP, ask seronegative individuals about recent (in past month) potential exposure events (e.g., condomless sex or condom breaking during sex with a partner of unknown HIV-1 status or unknown viremic status, or a recent STI), and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash).
- If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute or primary HIV-1 infection.
While using DESCOVY for HIV-1 PrEP, HIV-1 testing should be repeated at least every 3 months, and upon diagnosis of any other STIs
- If an HIV-1 test indicates possible HIV-1 infection, or if symptoms consistent with acute HIV-1 infection develop following a potential exposure event, convert the HIV-1 PrEP regimen to an HIV treatment regimen until negative infection status is confirmed using a test approved or cleared by the FDA as an aid in the diagnosis of acute or primary HIV-1 infection.
Counsel individuals without HIV-1 to strictly adhere to the once daily DESCOVY dosing schedule. The effectiveness of DESCOVY in reducing the risk of acquiring HIV-1 is strongly correlated with adherence, as demonstrated by measurable drug levels in a clinical trial of DESCOVY for HIV-1 PrEP. Some individuals, such as adolescents, may benefit from more frequent visits and counseling to support adherence
Indications and Usage (DESCOVY is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and adolescent patients weighing at least 35 kg. DESCOVY is indicated for the treatment of HIV-1 infection in pediatric patients weighing at least 14 kg to less than 35 kg in combination with other antiretroviral agents, including darunavir and cobicistat but not other protease inhibitors that require a CYP3A inhibitor. | 06/2025 | ||||||
Dosage and Administration, Recommended Dosage for Treatment of HIV-1 Infection in Pediatric Patients Weighing at Least 14 kg to Less than 35 kg (The recommended dosage of DESCOVY for treatment of HIV-1 in pediatric patients is based on body weight and is provided in Table 1. This dosing information is applicable to pediatric patients with estimated creatinine clearance greater than or equal to 30 mL per minute [see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)] who are receiving DESCOVY with other antiretroviral agents, including darunavir (DRV) and cobicistat (COBI) but not including other HIV-1 protease inhibitors that are administered with either ritonavir or cobicistat.
For specific dosing recommendations for coadministered antiretroviral drugs, refer to their respective prescribing information [see Drug Interactions (7)] . | 06/2025 |
HIV-1 Treatment (
DESCOVY is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and adolescent patients weighing at least 35 kg.
DESCOVY is a two-drug combination of emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated:
- in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and adolescent patients weighing at least 35 kg.
- for the treatment of HIV-1 infection in pediatric patients weighing at least 14 kg to less than 35 kg in combination with other antiretroviral agents, including darunavir and cobicistat but not other protease inhibitors that require a CYP3A inhibitor.
HIV-1 PrEP (
DESCOVY is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sexual acquisition, excluding individuals at risk from receptive vaginal sex. Individuals must have a negative HIV-1 test immediately prior to initiating DESCOVY for HIV-1 PrEP
Limitations of Use:
The indication does not include use of DESCOVY in individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated
DESCOVY is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sexual acquisition, excluding individuals at risk from receptive vaginal sex. Individuals must have a negative HIV-1 test immediately prior to initiating DESCOVY for HIV-1 PrEP.
Limitations of Use (
DESCOVY is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sexual acquisition, excluding individuals at risk from receptive vaginal sex. Individuals must have a negative HIV-1 test immediately prior to initiating DESCOVY for HIV-1 PrEP
Limitations of Use:
The indication does not include use of DESCOVY in individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated
The indication does not include use of DESCOVY in individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated.
- Testing: Prior to or when initiating DESCOVY, test for hepatitis B virus infection. Prior to or when initiating DESCOVY, and during use on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all individuals. In individuals with chronic kidney disease, also assess serum phosphorus. ()
2.1 Testing When Initiating and During Use of DESCOVY for Treatment of HIV-1 Infection or for HIV-1 PrEPPrior to or when initiating DESCOVY, test individuals for hepatitis B virus infection
[see Warnings and Precautions (5.1)].Prior to or when initiating DESCOVY, and during use of DESCOVY on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all individuals. In individuals with chronic kidney disease, also assess serum phosphorus
[see Warnings and Precautions (5.4)]. - HIV-1 Screening: Screen all individuals for HIV-1 infection immediately prior to initiating DESCOVY for HIV-1 PrEP and at least once every 3 months while taking DESCOVY, and upon diagnosis of any other sexually transmitted infections (STIs). ()
2.2 HIV-1 Screening for Individuals Receiving DESCOVY for HIV-1 PrEPScreen all individuals for HIV-1 infection immediately prior to initiating DESCOVY for HIV-1 PrEP and at least once every 3 months while taking DESCOVY, and upon diagnosis of any other sexually transmitted infections (STIs)
[see Indications and Usage (1.2), Contraindications (4), and Warnings and Precautions (5.2)].If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute or primary HIV-1 infection
[see Warnings and Precautions (5.2), Use in Specific Populations (8.4), and Clinical Studies (14.3)]. - Recommended dosage:
- Treatment of HIV-1 Infection:
- Adult and pediatric patients weighing at least 35 kg: One 200 mg/25 mg tablet once daily with or without food. ()
2.3 Recommended Dosage for Treatment of HIV-1 Infection in Adults and Pediatric Patients Weighing at Least 35 kgDESCOVY is a two-drug fixed dose combination product containing emtricitabine (FTC) and tenofovir alafenamide (TAF).
The recommended dosage of DESCOVY for treatment of HIV-1 is one tablet containing 200 mg FTC and 25 mg of TAF taken orally once daily with or without food in:
- adults and pediatric patients with body weight at least 35 kg and estimated creatinine clearance greater than or equal to 30 mL per minute; or
- adults with creatinine clearance below 15 mL per minute who are receiving chronic hemodialysis. On days of hemodialysis, administer the daily dose of DESCOVY after completion of hemodialysis treatment[see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)].
The safety and effectiveness of DESCOVY coadministered with an HIV-1 protease inhibitor that is administered with either ritonavir or cobicistat have not been established in adults with creatinine clearance below 15 mL per minute, with or without hemodialysis.
For specific dosing recommendations for coadministered antiretroviral drugs, refer to their respective prescribing information
[see Drug Interactions (7)]. - Pediatric patients receiving DESCOVY with other antiretroviral agents, including darunavir and cobicistat but not other protease inhibitors administered with either ritonavir or cobicistat, and weighing:
- at least 25 to less than 35 kg: One 200 mg/25 mg tablet once daily with or without food. ()
2.4 Recommended Dosage for Treatment of HIV-1 Infection in Pediatric Patients Weighing at Least 14 kg to Less than 35 kgThe recommended dosage of DESCOVY for treatment of HIV-1 in pediatric patients is based on body weight and is provided in Table 1. This dosing information is applicable to pediatric patients with estimated creatinine clearance greater than or equal to 30 mL per minute[see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)]who are receiving DESCOVY with other antiretroviral agents, including darunavir (DRV) and cobicistat (COBI) but not including other HIV-1 protease inhibitors that are administered with either ritonavir or cobicistat.Table 1 Dosing for Treatment of HIV-1 Infection in Pediatric Patients Weighing 14 to Less than 35 kg Body Weight (kg) DESCOVY Dosage 25 kg to less than 35 kg One tablet containing 200 mg of FTC and 25 mg of TAF taken orally once daily 14 kg to less than 25 kg One tablet containing 120 mg of FTC and 15 mg of TAF taken orally once daily For specific dosing recommendations for coadministered antiretroviral drugs, refer to their respective prescribing information
[see Drug Interactions (7)]. - at least 14 to less than 25 kg: One 120 mg/15 mg tablet once daily with or without food. ()
2.4 Recommended Dosage for Treatment of HIV-1 Infection in Pediatric Patients Weighing at Least 14 kg to Less than 35 kgThe recommended dosage of DESCOVY for treatment of HIV-1 in pediatric patients is based on body weight and is provided in Table 1. This dosing information is applicable to pediatric patients with estimated creatinine clearance greater than or equal to 30 mL per minute[see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)]who are receiving DESCOVY with other antiretroviral agents, including darunavir (DRV) and cobicistat (COBI) but not including other HIV-1 protease inhibitors that are administered with either ritonavir or cobicistat.Table 1 Dosing for Treatment of HIV-1 Infection in Pediatric Patients Weighing 14 to Less than 35 kg Body Weight (kg) DESCOVY Dosage 25 kg to less than 35 kg One tablet containing 200 mg of FTC and 25 mg of TAF taken orally once daily 14 kg to less than 25 kg One tablet containing 120 mg of FTC and 15 mg of TAF taken orally once daily For specific dosing recommendations for coadministered antiretroviral drugs, refer to their respective prescribing information
[see Drug Interactions (7)].
- at least 25 to less than 35 kg: One 200 mg/25 mg tablet once daily with or without food. (
- Adult and pediatric patients weighing at least 35 kg: One 200 mg/25 mg tablet once daily with or without food. (
- HIV-1 PrEP:One 200 mg/25 mg tablet once daily with or without food in individuals with body weight at least 35 kg. ()
2.5 Recommended Dosage for HIV-1 PrEP in Adults and Adolescents Weighing at Least 35 kgThe dosage of DESCOVY for HIV-1 PrEP is one tablet (containing 200 mg of FTC and 25 mg of TAF) once daily taken orally with or without food in:
- adults and adolescents without HIV-1 weighing at least 35 kg and with a creatinine clearance greater than or equal to 30 mL per minute; or
- adults without HIV-1 and with creatinine clearance below 15 mL per minute who are receiving chronic hemodialysis. On days of hemodialysis, administer the daily dose of DESCOVY after completion of hemodialysis treatment[see Indications and Usage (1.2)and Clinical Pharmacology (12.3)].
- Renal impairment: DESCOVY is not recommended in individuals with estimated creatinine clearance of 15 to below 30 mL per minute, or below 15 mL per minute who are not receiving chronic hemodialysis. ()
2.6 Not Recommended in Individuals with Severe Renal Impairment for Treatment of HIV-1 Infection or for HIV-1 PrEPDESCOVY is not recommended in individuals with:
- severe renal impairment (estimated creatinine clearance of 15 to below 30 mL per minute); or
- end stage renal disease (ESRD; estimated creatinine clearance below 15 mL per minute) who are not receiving chronic hemodialysis[see Dosage and Administration (2.3,2.5)and Use in Specific Populations (8.6)].
DESCOVY tablets are available in two dose strengths:
- 200 mg/25 mg tablets: 200 mg of emtricitabine (FTC) and 25 mg of tenofovir alafenamide (TAF) (equivalent to 28 mg of tenofovir alafenamide fumarate). These tablets are blue, rectangular-shaped, film-coated, debossed with “GSI” on one side and “225” on the other side.
- 120 mg/15 mg tablets: 120 mg of FTC and 15 mg of TAF (equivalent to 16.8 mg of tenofovir alafenamide fumarate). These tablets are white, round-shaped, film coated, debossed with “GSI” on one side and “15” on the other side.
- Pediatrics:
- Treatment of HIV-1 Infection:Not recommended for patients weighing less than 14 kg. ()
8.4 Pediatric UseThe safety and effectiveness of DESCOVY for the treatment of HIV-1 infection have been established in pediatric patients weighing at least 14 kg
[see Indications and Usage (1.1)and Dosage and Administration (2.2)].Treatment of HIV-1 InfectionAdolescent Patients Weighing at Least 35 kg:The safety and effectiveness of DESCOVY in combination with other antiretroviral agents for the treatment of HIV-1 infection was established in adolescent patients weighing at least 35 kg.
Use of DESCOVY in adolescent patients is supported by adequate and well controlled trials of FTC+TAF with EVG+COBI in adults and by an open-label trial in antiretroviral treatment-naïve pediatric participants with HIV-1 aged 12 to less than 18 years and weighing at least 35 kg through Week 48 (N=50; Study 106 [cohort 1]) administered FTC+TAF with EVG+COBI. The safety and effectiveness of FTC+TAF with EVG+COBI in adolescent participants was similar to that in adults on this regimen
[see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.2)].Pediatric Patients Weighing at least 14 kg and Less than 35 kg:The safety and effectiveness of DESCOVY in combination with other antiretroviral agents, including darunavir and cobicistat (DRV+COBI) but not including other protease inhibitors that require a CYP3A inhibitor, for the treatment of HIV-1 infection was established in pediatric patients weighing at least 14 kg to less than 35 kg
[see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.2)].Use of DESCOVY in pediatric patients weighing at least 14 kg to less than 35 kg is supported by:
- adequate and well controlled trials of FTC+TAF with EVG+COBI in adults;
- an open-label trial in virologically-suppressed pediatric participants aged 6 to less than 12 years and weighing at least 25 kg (N=52; Study 106 [cohort 2]) administered FTC+TAF with EVG+COBI through Week 48;
- an open-label trial of DESCOVY administered in combination with DRV+COBI in virologically-suppressed pediatric participants at least 2 years of age and weighing at least 14 kg to less than 40 kg (n=20; Study 128 [cohort 2 and 3]) through Week 48;
- an open-label trial of FTC+TAF with bictegravir in virologically-suppressed pediatric participants at least 2 years of age and weighing at least 14 to less than 25 kg through Week 24 (N=22; Study 1474 [cohort 3]).
Overall, the safety and effectiveness of FTC+TAF in pediatric participants in these trials were similar to that observed in adults. Specifically, the safety and efficacy of FTC+TAF with EVG+COBI in participants 6 to 12 years of age and weighing at least 25 kg were similar to that in antiretroviral treatment-naïve adults and adolescents receiving this regimen, with the exception of a decrease from baseline in CD4+ cell count. The safety and effectiveness of DESCOVY when administered with DRV+COBI in pediatric participants weighing at least 14 kg to less than 40 kg were similar to that in adults.
Use of DESCOVY with Other Protease Inhibitors that Require CYP3A Inhibition in Pediatric Patients Weighing at least 14 kg to Less than 35 kg:
The use of DESCOVY with atazanavir and cobicistat (ATV+COBI) is not recommended in pediatric patients weighing at least 14 kg to less than 35 kg.
The use of DESCOVY with ATV+COBI was studied in pediatric patients weighing at least 14 kg to less than 35 kg. In Study 128, participants who received ATV+COBI in cohort 2 (25 kg to <40 kg, n=14) and cohort 3 (14 kg to <25 kg, n=15) showed TAF exposures (Cmaxand AUC) that exceeded adult exposures by 4–5-fold in cohort 2, and 2–3-fold in cohort 3. Limited safety data were available to support the increased TAF exposures. Therefore, the use of DESCOVY with ATV+COBI is not recommended in pediatric patients weighing at least 14 kg to less than 35 kg.
Safety and effectiveness of DESCOVY in combination with protease inhibitors that require ritonavir in pediatric patients weighing at least 14 kg to less than 35 kg have not been established.
Pediatric Patients Weighing less than 14 kg:Safety and effectiveness of DESCOVY for treatment of HIV-1 infection in pediatric patients weighing less than 14 kg have not been established.
HIV-1 PrEPSafety and effectiveness of DESCOVY for HIV-1 PrEP in at-risk adolescents weighing at least 35 kg, excluding individuals at risk from receptive vaginal sex, is supported by data from an adequate and well-controlled trial of DESCOVY for HIV-1 PrEP in adults with additional data from safety and pharmacokinetic studies in previously conducted trials with the individual drug products, FTC and TAF, with EVG+COBI, in adults and pediatric participants with HIV-1
[see Dosage and Administration (2.5), Adverse Reactions (6.1), Clinical Pharmacology (12.3and 12.4), and Clinical Studies (14)].While using DESCOVY for HIV-1 PrEP, HIV-1 testing should be repeated at least every 3 months, and upon diagnosis of any other STIs. Previous studies in at-risk adolescents indicated waning adherence to a daily oral PrEP regimen once visits were switched from monthly to quarterly visits. Adolescents may therefore benefit from more frequent visits and counseling
[see Warnings and Precautions (5.2)].Safety and effectiveness of DESCOVY for HIV-1 PrEP in pediatric individuals weighing less than 35 kg have not been established.
- HIV-1 PrEP:Not recommended for individuals weighing less than 35 kg. ()
8.4 Pediatric UseThe safety and effectiveness of DESCOVY for the treatment of HIV-1 infection have been established in pediatric patients weighing at least 14 kg
[see Indications and Usage (1.1)and Dosage and Administration (2.2)].Treatment of HIV-1 InfectionAdolescent Patients Weighing at Least 35 kg:The safety and effectiveness of DESCOVY in combination with other antiretroviral agents for the treatment of HIV-1 infection was established in adolescent patients weighing at least 35 kg.
Use of DESCOVY in adolescent patients is supported by adequate and well controlled trials of FTC+TAF with EVG+COBI in adults and by an open-label trial in antiretroviral treatment-naïve pediatric participants with HIV-1 aged 12 to less than 18 years and weighing at least 35 kg through Week 48 (N=50; Study 106 [cohort 1]) administered FTC+TAF with EVG+COBI. The safety and effectiveness of FTC+TAF with EVG+COBI in adolescent participants was similar to that in adults on this regimen
[see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.2)].Pediatric Patients Weighing at least 14 kg and Less than 35 kg:The safety and effectiveness of DESCOVY in combination with other antiretroviral agents, including darunavir and cobicistat (DRV+COBI) but not including other protease inhibitors that require a CYP3A inhibitor, for the treatment of HIV-1 infection was established in pediatric patients weighing at least 14 kg to less than 35 kg
[see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.2)].Use of DESCOVY in pediatric patients weighing at least 14 kg to less than 35 kg is supported by:
- adequate and well controlled trials of FTC+TAF with EVG+COBI in adults;
- an open-label trial in virologically-suppressed pediatric participants aged 6 to less than 12 years and weighing at least 25 kg (N=52; Study 106 [cohort 2]) administered FTC+TAF with EVG+COBI through Week 48;
- an open-label trial of DESCOVY administered in combination with DRV+COBI in virologically-suppressed pediatric participants at least 2 years of age and weighing at least 14 kg to less than 40 kg (n=20; Study 128 [cohort 2 and 3]) through Week 48;
- an open-label trial of FTC+TAF with bictegravir in virologically-suppressed pediatric participants at least 2 years of age and weighing at least 14 to less than 25 kg through Week 24 (N=22; Study 1474 [cohort 3]).
Overall, the safety and effectiveness of FTC+TAF in pediatric participants in these trials were similar to that observed in adults. Specifically, the safety and efficacy of FTC+TAF with EVG+COBI in participants 6 to 12 years of age and weighing at least 25 kg were similar to that in antiretroviral treatment-naïve adults and adolescents receiving this regimen, with the exception of a decrease from baseline in CD4+ cell count. The safety and effectiveness of DESCOVY when administered with DRV+COBI in pediatric participants weighing at least 14 kg to less than 40 kg were similar to that in adults.
Use of DESCOVY with Other Protease Inhibitors that Require CYP3A Inhibition in Pediatric Patients Weighing at least 14 kg to Less than 35 kg:
The use of DESCOVY with atazanavir and cobicistat (ATV+COBI) is not recommended in pediatric patients weighing at least 14 kg to less than 35 kg.
The use of DESCOVY with ATV+COBI was studied in pediatric patients weighing at least 14 kg to less than 35 kg. In Study 128, participants who received ATV+COBI in cohort 2 (25 kg to <40 kg, n=14) and cohort 3 (14 kg to <25 kg, n=15) showed TAF exposures (Cmaxand AUC) that exceeded adult exposures by 4–5-fold in cohort 2, and 2–3-fold in cohort 3. Limited safety data were available to support the increased TAF exposures. Therefore, the use of DESCOVY with ATV+COBI is not recommended in pediatric patients weighing at least 14 kg to less than 35 kg.
Safety and effectiveness of DESCOVY in combination with protease inhibitors that require ritonavir in pediatric patients weighing at least 14 kg to less than 35 kg have not been established.
Pediatric Patients Weighing less than 14 kg:Safety and effectiveness of DESCOVY for treatment of HIV-1 infection in pediatric patients weighing less than 14 kg have not been established.
HIV-1 PrEPSafety and effectiveness of DESCOVY for HIV-1 PrEP in at-risk adolescents weighing at least 35 kg, excluding individuals at risk from receptive vaginal sex, is supported by data from an adequate and well-controlled trial of DESCOVY for HIV-1 PrEP in adults with additional data from safety and pharmacokinetic studies in previously conducted trials with the individual drug products, FTC and TAF, with EVG+COBI, in adults and pediatric participants with HIV-1
[see Dosage and Administration (2.5), Adverse Reactions (6.1), Clinical Pharmacology (12.3and 12.4), and Clinical Studies (14)].While using DESCOVY for HIV-1 PrEP, HIV-1 testing should be repeated at least every 3 months, and upon diagnosis of any other STIs. Previous studies in at-risk adolescents indicated waning adherence to a daily oral PrEP regimen once visits were switched from monthly to quarterly visits. Adolescents may therefore benefit from more frequent visits and counseling
[see Warnings and Precautions (5.2)].Safety and effectiveness of DESCOVY for HIV-1 PrEP in pediatric individuals weighing less than 35 kg have not been established.