Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication HIV-1 Treatment ( 1.1 ): 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. FDA label
Descovy · 4 trials · 3 indications
Sustained Virologic Response (SVR12) was defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after stopping LDV/SOF treatment.
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
AUCtau is defined as the area under the drug concentration versus time curve over the dosing interval.
AUCtau is defined as the area under the drug concentration versus time curve over the dosing interval.
An AE is any untoward medical occurrence in a clinical study participant which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The TEAEs were defined as any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug.
| Arm | Type | Description |
|---|---|---|
| E/C/F/TAF + LDV/SOF | EXPERIMENTAL | Part 1: Participants will switch from 2 nucleoside reverse transcriptase inhibitors (NRTI) plus a third agent to E/C/F/TAF. Part 2: After 8 weeks of E/C/F/TAF treatment, the participants maintaining HIV-1 RNA \< 50 copies/mL will start receiving LDV/SOF for 12 weeks and continue their HIV treatment until the end of the study. |
| F/R/TAF + LDV/SOF | EXPERIMENTAL | Part 1: Participants will switch from 2 NRTI plus a third agent to F/R/TAF. Part 2: After 8 weeks of F/R/TAF treatment, the participants maintaining HIV-1 RNA \< 50 copies/mL will start receiving LDV/SOF for 12 weeks and continue their HIV treatment until the end of the study. |
| B/F/TAF | EXPERIMENTAL | B/F/TAF + DTG + F/TAF placebo administered without regard to food for at least 144 weeks. |
| DTG + F/TAF | ACTIVE_COMPARATOR | DTG + F/TAF+ B/F/TAF placebo administered without regard to food for at least 144 weeks. |
| Open-label Phase B/F/TAF from B/F/TAF | EXPERIMENTAL | After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first. |
| Open-label Phase B/F/TAF from DTG + F/TAF | EXPERIMENTAL | After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first. |
| F/TAF (Double-Blind) | EXPERIMENTAL | F/TAF + ABC/3TC placebo + allowed 3rd antiretroviral (ARV) agent for 96 weeks After Week 96, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments have been unblinded. |
| ABC/3TC (Double-Blind) | ACTIVE_COMPARATOR | ABC/3TC + F/TAF placebo + allowed 3rd ARV agent for 96 weeks After Week 96, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments have been unblinded. |
| Open-Label F/TAF | EXPERIMENTAL | After the unblinding visit, in countries where F/TAF FDC is not commercially available, participants (except in certain countries such as the UK) will be given the option to receive open-label F/TAF (200/10 mg or 200/25 mg) FDC and attend study visits every 12 weeks until it becomes commercially available, or until Gilead terminates the study in that country. |
| F/TAF+3rd ARV Agent (Cohort 1) | EXPERIMENTAL | Participants between 12 to \< 18 years of age and ≥ 35 kg in body weight will switch their current 2-NRTI containing regimen to F/TAF (200/25 mg for unboosted 3rd agent and 200/10 mg for boosted 3rd agent) while continuing on their 3rd ARV agent for 48 weeks. |
| F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1) | EXPERIMENTAL | Participants between 6 to \< 12 years of age and ≥ 25 kg in body weight must be on a boosted protease inhibitor (PI) as their 3rd ARV agent and will switch their current 2-NRTI regimen to F/TAF 200/25 mg while continuing on their boosted PI for 48 weeks. |
| F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2) | EXPERIMENTAL | Participants between 2 to \< 12 years of age and between 17 kg to \< 25 kg in body weight must be on a boosted protocol specified 3rd ARV agent and will switch their current 2-NRTI containing regimen to F/TAF 120/15 mg while continuing their 3rd ARV agent for 48 weeks. |
| FTC/TAF+3rd ARV Agent (Cohort 3, Part A) | EXPERIMENTAL | Participants between 2 to \< 6 years of age will receive F/TAF plus a 3rd ARV agent through 48 weeks. |
| FTC/TAF+3rd ARV Agent (Cohort 4, Part A) | EXPERIMENTAL | Participants between 1 month to \< 2 years of age will receive F/TAF plus a 3rd ARV agent through 48 weeks. |
| F/TAF+3rd ARV Agent (Cohort 2, Part B - Group 1) | EXPERIMENTAL | Screening will be initiated for Part B following confirmation of TAF dose in Part A. Approximately 10 additional total participants will be enrolled across all Part B cohorts and will receive F/TAF while continuing their 3rd ARV agent through 48 weeks. |
| F/TAF+3rd ARV Agent (Cohort 2, Part B - Group 2) | EXPERIMENTAL | Screening will be initiated for Part B following confirmation of TAF dose in Part A. Approximately 10 additional total participants will be enrolled across all Part B cohorts and will receive F/TAF while continuing their 3rd ARV agent through 48 weeks. |
| FTC/TAF+3rd ARV Agent (Cohort 3, Part B) | EXPERIMENTAL | Screening will be initiated for Part B following confirmation of TAF dose in Part A. Approximately 10 additional total participants will be enrolled across all Part B cohorts and will receive F/TAF while continuing their 3rd ARV agent through 48 weeks. |
| FTC/TAF+3rd ARV Agent (Cohort 4, Part B) | EXPERIMENTAL | Screening will be initiated for Part B following confirmation of TAF dose in Part A. Approximately 10 additional total participants will be enrolled across all Part B cohorts and will receive F/TAF while continuing their 3rd ARV agent through 48 weeks. |
| FTC/TAF+3rd ARV Agent (Extension Phase) | EXPERIMENTAL | After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. |
| Name | Type | Description |
|---|---|---|
| E/C/F/TAF | DRUG | 150/150/200/10 mg fixed dose combination (FDC) tablet administered orally once daily |
| F/R/TAF | DRUG | 200/25/25 mg FDC tablet administered orally once daily |
| LDV/SOF | DRUG | 90/400 mg FDC tablet administered orally once daily |
| DTG | DRUG | 50 mg tablets administered orally, once daily |
| F/TAF | DRUG | 200/25 mg tablets administered orally, once daily |
| B/F/TAF | DRUG | 50/200/25 milligrams (mg) FDC tablets administered orally, once daily |
| DTG Placebo | DRUG | Tablets administered orally, once daily |
| F/TAF Placebo | DRUG | Tablets administered orally, once daily |
| B/F/TAF Placebo | DRUG | Tablets administered orally, once daily |
| ABC/3TC | DRUG | 600/300 mg FDC tablets administered orally once daily |
| ABC/3TC Placebo | DRUG | Tablets administered orally once daily |
| 3rd ARV agent | DRUG | An allowed 3rd ARV agent of the participant's pre-existing regimen may include one of the following boosted ARV agents: ritonavir boosted lopinavir (LPV/r), atazanavir (ATV) + ritonavir (RTV), ATV + cobicistat (COBI) or ATV/COBI FDC, darunavir (DRV) + RTV, DRV+COBI or DRV/COBI FDC; or, one of the following unboosted ARV agents: efavirenz (EFV), rilpivirine (RPV), raltegravir (RAL), dolutegravir (DTG), maraviroc (MVC), or nevirapine (NVP). |
| Boosted PIs | DRUG | Allowed boosted PIs: LPV, ATV, DRV. |
Key Inclusion Criteria: * Chronic genotype (GT) 1, HCV infected, male and non-pregnant/ non-lactating female individuals, without cirrhosis, treatment-naive or treatment-experienced with interferon (IFN) +/- ribavirin (RBV) +/- HCV protease inhibitor (PI). * Compensated cirrhotic individuals must b...
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Descovy is used to treat HIV-1 infection. It is studied in adults and in children and adolescents who are virologically suppressed, including as a switch option for patients already on other antiretroviral regimens. Its clinical program covers HIV-1 infection, with one trial also enrolling participants co-infected with HIV and HCV.
Descovy is developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. Gilead is the sponsor of the clinical trials evaluating the drug in HIV-1 infection.
Descovy has been studied in Phase 2 and Phase 3 clinical trials. The Phase 2 trial enrolled children and adolescents, while the Phase 3 trials enrolled adults, including treatment-naive patients and virologically suppressed patients switching regimens. All four listed trials are completed.
Descovy has been evaluated in completed trials including NCT02469246, a switch study in virologically suppressed adults; NCT02607956, a Phase 3 study in antiretroviral treatment-naive adults; NCT02707601, a Phase 3 study in HIV/HCV co-infected participants; and NCT02285114, a Phase 2 study in children and adolescents.
Across the four completed trials, 1,415 participants were enrolled. The largest was NCT02607956 with 657 participants, followed by NCT02469246 with 567, NCT02707601 with 150, and NCT02285114 with 41. Enrollment included adults and children as young as 1 month.