Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication BIKTARVY is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg: who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected… FDA label
Also known as Bictegravir
Biktarvy · 15 trials · 5 indications
Patients will be considered non-eligible if they meet one or more of the following creiteria at week 4: * Presence of HLA-B\* 5701 or lack of HLA test * Presence of HIV genotypic resistance mutations to at least one class of ARV drug that decrease efficacy of antiretroviral treatment * CD4 count \< 200 cells/mm3 * Viral load \> 100.000 copies/mL * Comorbidities such as: Osteopenia measured by DXA (T score less than 1), medical history of cardiovascular risk measured by Framingham risk score \> 10% at 10 years, Kidney function (eGFR \<50mL/min), * Concomitant medication that can cause potential interactions with ARV (evaluating the risk of drug-drug interactions for drugs no totally safe (green colour) using the Liverpool website for DDI) * Hepatitis B (HBV) coinfection or lack of serology
The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined 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. Percentages were rounded-off.
This outcome measure was analyzed using a Missing = Failure approach. In this approach, all missing data were treated as HBV DNA ≥ 29 IU/mL. Percentages were rounded-off.
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined timepoint within an allowed window of time, along with study drug discontinuation status.
The percentage of participants with 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.
Treatment-emergent Adverse Events (TEAE) were defined as AEs with onset dates on or after the study drug start date and no later than 30 days after the permanent discontinuation of the E/C/F/TAF (GEN Phase) study drug or all AEs for participants still on E/C/F/TAF. It also includes the AEs that led to premature discontinuation of E/C/F/TAF study drug. Clinical events and clinically significant laboratory abnormalities were graded according to the GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities. Adverse events were graded as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (life threatening).
Participants who had the last available on-treatment HIV-1 RNA≥ 50 copies/mL in the week 24 analysis window, or who did not have on-treatment HIV-1 RNA data in the week 24 analysis window and participants who discontinued study drug prior to or in the week 24 analysis window due to lack of efficacy, or who discontinued study drug prior to or in the week 24 analysis window due to adverse event (AE) or death and have the last available on-treatment HIV-1 RNA≥ 50 copies/mL, or who discontinued study drug prior to or in the week 24 analysis window due to reasons other than AE, death, or lack of efficacy and have the last available on-treatment HIV-1 RNA ≥ 50 copies/mL were included. The Week 24 window for snapshot algorithm was between Days 127 and 210 (inclusively). Percentages were rounded off.
Participants who had the last available on-treatment HIV-1 RNA ≥ 50 copies/mL in the Week 48 analysis window, or who did not have on-treatment HIV-1 RNA data in the Week 48 analysis window and who discontinued study drug prior to or in the Week 48 analysis window due to lack of efficacy, or who discontinued study drug prior to or in the Week 48 analysis window due to AE or death and have the last available on-treatment HIV-1 RNA ≥ 50 copies/mL, or who discontinued study drug prior to or in the Week 48 analysis window due to reasons other than AE, death, or lack of efficacy and have the last available on-treatment HIV-1 RNA ≥ 50 copies/mL were included. The Week 48 window for snapshot algorithm was between Days 295 and 378 (inclusively). Percentages were rounded off.
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). Cohorts 1 \& 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose. Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
Ctau is defined as the observed drug concentration at the end of the dosing interval. Cohorts 1 \& 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose. Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
Cmax is defined as maximum observed concentration of drug. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time.
AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration.
AUC0-24h is defined as the partial area under the concentration versus time curve from time 0 to time 24 hours.
Cmax is defined as the maximum observed concentration of drug.
Tmax is defined as the time (observed time point) of Cmax.
Cmin is defined as the minimum observed concentration of drug.
C24h is defined as the concentration of drug at time 24 hours.
t1/2 is defined as the terminal elimination half-life.
Apparent CL/F is defined as the apparent total body clearance for extravascular administration.
Apparent Vz/F is defined as the apparent volume of distribution based on the terminal phase.
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time.
Free AUCinf was calculated based on unbound plasma bictegravir (AUCinf × percentage unbound bictegravir ÷ 100 for each participant).
AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration.
Free AUClast was calculated based on unbound plasma bictegravir (AUClast × percentage unbound bictegravir ÷ 100 for each participant).
Cmax is defined as the maximum observed plasma concentration of drug.
Free Cmax was calculated based on unbound plasma bictegravir (Cmax × percentage unbound bictegravir ÷ 100 for each participant).
DAVG11 was defined as the time-weighted average between the first postbaseline value through the last available on-treatment (ie, the last dose date + 1) value up to Day 11 minus the baseline value in plasma HIV-1 RNA (log10 copies/mL). All HIV-1 RNA data up to Day 11 were used for this analysis. DAVG11 was calculated using the trapezoidal rule and the area-under-the-curve concept.
The primary outcome measure is the pharmacokinetic (PK) parameters for GS-9973 including AUC and Cmax.
| Arm | Type | Description |
|---|---|---|
| Biktarvy | EXPERIMENTAL | This is a fixed dose combination regimen containing 50 mg of Bictegravir + 200 mg of Emtricitabine + 25 mg of Tenofovir alafenamide. |
| Treatment Group 1: Bictegravir (BIC)/ Lenacapavir (LEN) (75/50 mg) + PTM B/F/TAF | EXPERIMENTAL | Blinded Phase: Participants will switch from bictegravir/emtricitabine/tenofovir (B/F/TAF) FDC tablets to BIC/LEN (75/50 mg) FDC tablets and placebo-to-match (PTM) B/F/TAF. Participants will receive a 2-day oral loading dose of LEN 600 mg on Day 1 and on Day 2, in addition to the daily doses of BIC/LEN FDC tablet starting on Day 1 up to end of blinded treatment (EBT) visit. Open-label (OL) Phase: Following treatment in the Blinded Phase, participants from Treatment Group 1 will receive BIC/LEN FDC tablets through Week 48 in the Open-label Phase. At the OL Week 48 visit, participants from Treatment Group 1 will be given the option to continue to receive BIC/LEN FDC tablets until the conclusion of the OL Phase. |
| Treatment Group 2: B/F/TAF (50/200/25 mg) + PTM BIC/LEN | EXPERIMENTAL | Blinded Phase: Participants will continue with their B/F/TAF (50/200/25 mg) FDC tablets and start PTM BIC/LEN tablets on Day 1. Participants will receive PTM LEN tablets for 2 days (2 PTM LEN tablets on Day 1 and on Day 2. The blinded phase will continue until the EBT visit. Open Label Phase: Participants in Treatment Group 2 who complete the EBT visit will be given the option to enter the OL phase to receive BIC/LEN FDC tablets until the conclusion of the OL Phase. |
| B/F/TAF | EXPERIMENTAL | Participants will receive B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food. At Week 48, participants who wish to continue on B/F/TAF will be given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they have access to B/F/TAF, whichever occurs first. |
| Stay on Baseline Regimen (SBR)/ Delayed B/F/TAF | ACTIVE_COMPARATOR | Participants will stay on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks with a delayed switch to B/F/TAF (50/200/25 mg) FDC tablet administered orally, once daily until Week 48 without regard to food. At Week 48, participants who wish to continue on B/F/TAF will be given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they have access to B/F/TAF, whichever occurs first. |
| Blinded Phase: B/F/TAF | EXPERIMENTAL | Participants who are HIV-1 and HBV co-infected and treatment-naïve will receive Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed-dose combination (FDC) tablet in addition to placebo to match (PTM) dolutegravir (DTG) tablet and PTM FDC emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet for 96 weeks. |
| Blinded Phase: DTG+F/TDF | ACTIVE_COMPARATOR | Participants who are HIV-1 and HBV co-infected and treatment-naïve will receive DTG and FDC F/TDF in addition to PTM B/F/TAF for 96 weeks. |
| Open-label Extension Phase: B/F/TAF from B/F/TAF | EXPERIMENTAL | After Week 96, 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 in a country where B/F/TAF FDC is not available will be given the option to receive B/F/TAF FDC in an open-label extension phase for up to 48 weeks, or 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 Extension Phase: B/F/TAF from DTG+F/TDF | EXPERIMENTAL | After Week 96, 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 in a country where B/F/TAF FDC is not available will be given the option to receive B/F/TAF FDC in an open-label extension phase for up to 48 weeks, or until the product becomes accessible through an access program, or until Gilead elects to discontinue the study in that country, whichever occurs first. |
| DTG + F/TAF | ACTIVE_COMPARATOR | DTG 50 mg tablet + F/TAF FDC tablet + B/F/TAF placebo tablet administered without regard to food for at least 48 weeks. |
| Open-label Phase B/F/TAF from B/F/TAF | EXPERIMENTAL | Participants who received B/F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase. |
| Open-label Phase B/F/TAF from DTG + F/TAF | EXPERIMENTAL | Participants who received DTG + F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase. |
| E/C/F/TAF | EXPERIMENTAL | Participants will switch their current antiretroviral regimen to E/C/F/TAF and receive treatment for 96 weeks. After Week 96, participants in the United States (US) who wish to participate in the open-label (OL) rollover extension will continue to take E/C/F/TAF FDC until the End of E/C/F/TAF Visit. |
| Open-Label Rollover Extension B/F/TAF | EXPERIMENTAL | At Week 96 or the End of E/C/F/TAF Visit (whichever occurs last), participants will be given the option to receive open-label bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for at least 48 weeks. |
| Treatment Arm A: B/F/TAF | ACTIVE_COMPARATOR | Participants will receive B/F/TAF 50/200/25 mg once daily for at least 48 weeks. After Week 48, participants in the Randomized Phase may be offered to continue to receive study drug in the Extension Phase. |
| Treatment Arm B: GS-3242 + LEN | EXPERIMENTAL | Participants will be randomized to oral loading dose of GS-3242 in combination with LEN, followed by a once-weekly oral combination regimen of GS-3242 and LEN (at a different dose than Treatment C), administered concomitantly for at least 48 weeks. After Week 48, participants in the Randomized Phase may be offered to continue to receive study drug in the Extension Phase. |
| Treatment Arm C: GS-3242 + LEN | EXPERIMENTAL | Participants will be randomized to oral loading dose of GS-3242 in combination with LEN, followed by a once-weekly oral combination regimen of GS-3242 and LEN (at a different dose than Treatment Arm B), administered concomitantly for at least 48 weeks. After Week 48, participants in the Randomized Phase may be offered to continue to receive study drug in the Extension Phase. |
| Phase 2: Treatment Group 1: BIC 75 mg + LEN 25 mg | EXPERIMENTAL | Participants will switch from their Stable Baseline Regimen (SBR) to a regimen of BIC 75 mg + LEN 25 mg, tablets administered orally once daily for up to 24 weeks. Participants will receive a 2-day pharmacokinetic (PK) oral loading dose of LEN 600 mg, on Days 1 and 2, in addition to the daily doses of BIC 75 mg + LEN 25 mg starting on Day 1. Participants who discontinue early or complete the Randomized Phase (RP) will have an option to continue in Extension Period (EP) |
| Phase 2: Treatment Group 2: BIC 75 mg + LEN 50 mg | EXPERIMENTAL | Participants will switch from their SBR to a regimen of BIC 75 mg + LEN 50 mg, tablets administered orally once daily for up to 24 weeks. Participants will receive a 2-day PK oral loading dose of LEN 600 mg, on Days 1 and 2, in addition to the daily doses of BIC 75 mg + LEN 50 mg starting on Day 1. Participants who discontinue early or complete the RP will have an option to continue in EP. |
| Phase 2: Treatment Group 3: SBR | ACTIVE_COMPARATOR | Participants will continue with their SBR for up to 24 weeks. Participants who discontinue early or complete the RP will have an option to continue in EP. |
| Phase 3: Treatment Group 1: BIC/LEN 75 mg/50 mg FDC | EXPERIMENTAL | Participants will switch from their SBR to a regimen of BIC/LEN 75mg/50mg FDC, administered orally once daily for up to 48 weeks. Participants will receive a 2-day PK oral loading dose of LEN 600 mg, on Days 1 and 2, in addition to the daily doses of BIC/LEN 75 mg/50 mg FDC starting on Day 1. Participants who discontinue early or complete the RP will have an option to continue in EP. |
| Phase 3: Treatment Group 2: SBR | ACTIVE_COMPARATOR | Participants will continue with their SBR for up to 48 weeks. Participants who will discontinue early or complete the RP had an option to continue in EP. |
| Phase 2/Phase 3:BIC/LEN 75/50 mg FDC | EXPERIMENTAL | At the end of randomized treatment, participants in Phase 2 and Phase 3 treatment groups who discontinue early or complete the RP will be given an option to enter in EP and will receive BIC/LEN 75/50 mg FDC until the drug is available in market or Gilead elects to withdraw the study. Participants in the SBR groups (Phase 2 Treatment Group 3 and Phase 3 Treatment Group 2 will also receive a 2-day PK oral loading dose of LEN 600 mg, on Days 1 and 2 of EP). |
| Cohort 1 (12 to < 18 years of age and weight ≥ 35 kg) | EXPERIMENTAL | * Part A: Participants will participate in an Intensive PK evaluation at Week 2 or Week 4 and continue to receive the adult strength B/F/TAF FDC through Week 48. * Part B: Following confirmation of BIC PK data from Cohort 1 Part A, participants will receive the adult strength B/F/TAF through Week 48. |
| Cohort 2 (6 to < 12 years of age and weight ≥ 25 kg) | EXPERIMENTAL | * Part A: Participants will participate in an Intensive PK evaluation at Week 2 or Week 4 and continue to receive the adult strength B/F/TAF FDC through Week 48. * Part B: Following confirmation of BIC PK data from Cohort 2 Part A, participants will receive the adult strength B/F/TAF FDC through Week 48. |
| Cohort 3 (≥ 2 years of age and weight ≥ 14 to < 25 kg) | EXPERIMENTAL | * Part A: Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive the low dose B/F/TAF FDC tablet through Week 48. * Part B: Following confirmation of BIC PK data from Cohort 3 Part A, participants will receive the low dose B/F/TAF FDC tablet through Week 48. |
| Cohort 4 Group 1 (≥ 2 years of age and weight ≥ 14 to < 25 kg) | EXPERIMENTAL | Due to Cohort 3 Part A Intensive PK evaluation at Week 2 with the low dose B/F/TAF FDC tablet, participants will not participate in an Intensive PK evaluation at Week 2. Participants will receive B/F/TAF FDC tablets for oral suspension (TOS) once daily through Week 48. |
| Cohort 4 Group 2 (≥ 1 month of age and weight ≥ 10 to < 14 kg) | EXPERIMENTAL | Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS twice daily through Week 48. |
| Cohort 4 Group 3 (≥ 1 month of age and weight ≥ 6 to < 10 kg) | EXPERIMENTAL | Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS twice daily through Week 48. |
| Cohort 4 Group 4 (≥ 1 month of age and weight ≥ 3 to < 6 kg) | EXPERIMENTAL | Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS twice daily through Week 48. |
| Open-Label Extension | EXPERIMENTAL | Following Week 48, participants in countries where B/F/TAF is not available may have the option to receive adult strength B/F/TAF FDC, low dose B/F/TAF FDC, or B/F/TAF FDC TOS (based on age and weight) until it becomes available for use according to the participant's age and weight or the product becomes accessible to participants through an access program. |
| Cohort 1: Group A of B/F/TAF | EXPERIMENTAL | Full-term neonate participants, who are exposed to HIV-1 but uninfected, with a weight of ≥ 2.5 kg at birth and their mothers will be assigned to Cohort 1 Group A to evaluate a different pharmacokinetic (PK) sampling scheme than Cohort 1 Group B. Neonate participants will receive a single dose of B/F/TAF fixed-dose combination 1.88/7.5/0.94 mg tablet for oral suspension administered along with 1 antiretroviral as standard of care postnatal prophylaxis at both Visits 1 and 3. |
| Cohort 1: Group B of B/F/TAF | EXPERIMENTAL | Once enrollment in Cohort 1 Group A is completed, full-term neonate participants, who are exposed to HIV-1 but uninfected, with a weight of ≥ 2.5 kg at birth and their mothers will be assigned to Cohort 1 Group B to evaluate a different PK sampling scheme than Cohort 1 Group A. Participants will receive a single dose of B/F/TAF fixed-dose combination 1.88/7.5/0.94 mg tablet for oral suspension administered along with 1 antiretroviral as standard of care postnatal prophylaxis at both Visits 1 and 3. |
| Neonates | NO_INTERVENTION | Neonates who will be born to women participants in the study will be followed from birth up to 8 weeks of age after obtaining consent from the parent or legal guardian. None of the neonates that participate in the study will be treated with the study drug. |
| Severe Renal Impairment | EXPERIMENTAL | Participants with severe renal impairment and matched healthy controls will receive a single dose of bictegravir. |
| Moderate Renal Impairment | EXPERIMENTAL | Participants with moderate renal impairment and matched healthy controls will receive a single dose of bictegravir. |
| Mild Renal Impairment | EXPERIMENTAL | Participants with mild renal impairment and matched healthy controls will receive a single dose of bictegravir. |
| Bictegravir 5 mg | EXPERIMENTAL | Bictegravir 5 mg (1 × 5 mg tablet) for 10 days |
| Bictegravir 25 mg | EXPERIMENTAL | Bictegravir 25 mg (1 × 25 mg tablet) for 10 days |
| Bictegravir 50 mg | EXPERIMENTAL | Bictegravir 50 mg (2 × 25 mg tablets) for 10 days |
| Bictegravir 100 mg | EXPERIMENTAL | Bictegravir 100 mg (1 × 100 mg tablet) for 10 days |
| Placebo | PLACEBO_COMPARATOR | Placebo matched to bictegravir tablet for 10 days |
| Sequence 1 | EXPERIMENTAL | - |
| Sequence 2 | EXPERIMENTAL | - |
| Sequence 3 | EXPERIMENTAL | - |
| Sequence 4 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Biktarvy | DRUG | Once daily fixed dose combination regimen of Biktarvy will be evaluated as a rapid treatment strategy in newly HIV diagnosed patients HIV diagnosed patients that come for the first time to the Hospital Clínic HIV Unit |
| Bictegravir | DRUG | Tablets administered orally without regard to food |
| Lenacapavir | DRUG | Tablets administered orally without regard to food |
| B/F/TAF | DRUG | Tablets administered orally without regard to food |
| Placebo to match B/F/TAF | DRUG | Tablets administered orally without regard to food |
| Placebo to match BIC/LEN | DRUG | Tablets administered orally without regard to food |
| NRTIs | DRUG | The following NRTIs will be administered as prescribed until Week 24 without regard to food: abacavir (ABC), emtricitabine (FTC), lamivudine (3TC), tenofovir alafenamide (TAF), tenofovir disoproxil fumarate (TDF), zidovudine (ZDV or AZT) |
| Third Agent | DRUG | Any one of the following third agents will be administered as prescribed. Protease inhibitors and EVG will be administered with the appropriate pharmacologic booster cobicistat or ritonavir. : * Non-nucleoside reverse transcriptase inhibitors (NNRTIs) * delavirdine (DLV) * efavirenz (EFV) * nevirapine (NVP) * rilpivirine (RPV) * doravirine (DOR) * Integrase inhibitors * dolutegravir (DTG) * elvitegravir (EVG) * raltegravir (RAL) * Protease inhibitors (PIs) * atazanavir (ATV) * darunavir (DRV) * lopinavir (LPV) * nelfinavir NFV) * saquinavir (SQV) * tipranavir (TPV) * Chemokine co-recptor 5 (CCR5) antagonist --maraviroc (MVC) |
| Placebo to match DTG | DRUG | Tablet administered orally once daily, without regard to food |
| Placebo to match F/TDF | DRUG | Tablet administered orally once daily, without regard to food |
| DTG | DRUG | 50 mg tablet administered orally once daily, without regard to food |
| F/TDF | DRUG | 200/300 mg tablet administered orally once daily, without regard to food |
| F/TAF | DRUG | 200/25 mg FDC tablet(s) administered orally once daily |
| DTG Placebo | DRUG | Tablet(s) administered orally once daily |
| F/TAF Placebo | DRUG | Tablet(s) administered orally once daily |
| B/F/TAF Placebo | DRUG | Tablet(s) administered orally once daily |
| E/C/F/TAF | DRUG | 150/150/200/10 mg FDC tablets administered orally once daily |
| GS-3242 | DRUG | Tablet administered orally |
| BIC/LEN FDC | DRUG | Tablets administered orally without regard to food |
| Stable Baseline Regimen | DRUG | SBR will include a combination of antiretroviral (ARV) regimen. ARV regimen may include the following, except for participants taking a single tablet regimen or taking a complete parenteral regimen (Cabenuva). * Nucleos(t)ide Reverse Transcriptase Inhibitors: * Abacavir * Emtricitabine * Lamivudine * Tenofovir alafenamide * Tenofovir disoproxil fumarate * Zidovudine * Non-Nucleosite Reverse Transcriptase Inhibitors: * Delavirdine * Efavirenz * Nevirapine * Rilpivirine * Doravirine * Integrase Inhibitors: * Bictegravir * Cabotegravir * Dolutegravir * Elvitegravir * Raltegravir * Protease Inhibitors: * Atazanavir * Darunavir * Fosamprenavir * Indinavir * Lopinavir * Nelfinavir * Saquinavir * Tipranavir * Chemokine Co-receptor 5 (CCR5) Antagonist: * Maraviroc * Fusion Inhibitors: * Enfuvirtide * gp120 Attachment Inhibitor: * Fostemsavir * Anti-CD4 Monoclonal Antibodies: * Ibalizumab-uiyk |
| B/F/TAF (Adult Strength) | DRUG | 50/200/25 mg FDC tablets administered orally once daily without regard to food. |
| B/F/TAF (Low Dose) | DRUG | 30/120/15 mg FDC tablets administered orally once daily without regard to food. |
| B/F/TAF (TOS) | DRUG | 2 x B/F/TAF 15/60/7.5 mg (total daily dose 30/120/15 mg) FDC tablets administered orally as TOS, once daily. |
| Placebo | DRUG | Placebo to match bictegravir administered orally once daily |
| Treatment A | DRUG | 1600 mg GS-9973 (Formulation 1) |
| Treatment B | DRUG | 1600 mg GS-9973 (Formulation 1) plus 20 mg omeprazole |
| Treatment C | DRUG | 1600 mg GS-9973 (Formulation 1) plus 40 mg famotidine |
| Treatment D | DRUG | 1600 mg GS-9973 (Formulation 2) |
| Treatment E | DRUG | 1600 mg GS-9973 (Formulation 2) plus 20 mg omeprazole |
| Treatment F | DRUG | 1600 mg GS-9973 (Formulation 2) plus 40 mg famotidine |
| Treatment G | DRUG | 1600 mg GS-9973 (Reference formulation) |
| Treatment H | DRUG | 1600 mg GS-9973 (Formulation 1 or Formulation 2, based on results from Part A) |
| Treatment I | DRUG | An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily |
| Treatment J | DRUG | An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily |
Inclusion Criteria: 1. Age ≥ 18 years old. 2. Having confirmed HIV-1 positive test. 3. Patients not previously treated with antiretroviral treatment (post-exposure prophylaxis will be allowed if not done in the previous 6 months). 4. Clinically stable patients, in the opinion of the investigator, a...
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| AN2 Therapeutics, Inc. | ANTX | 1 | PHASE2 | Epetraborole |
| Emergent BioSolutions Inc. | EBS | 4 | - | AIGIV/kg |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | - | Vonoprazan |
Biktarvy is a small molecule drug developed by Gilead Sciences, Inc. (ticker GILD) for HIV and related infections, including HIV-1 infection and HIV-1/HBV co-infection. It is also studied in chronic lymphocytic leukemia. Biktarvy is given as an oral treatment and is being evaluated in controlled clinical trials.
Biktarvy is used for the treatment of HIV-1 infection, including in people with undetectable virus levels and in newborns exposed to HIV. It is also studied for HIV-1/HBV co-infection. Trials compare Biktarvy with other regimens and evaluate long-acting oral HIV-1 treatments in adults.
Biktarvy is made by Gilead Sciences, Inc., which trades under the ticker GILD. Gilead is the developer running the clinical trial program for Biktarvy, including studies in HIV-1 infection and in newborns exposed to HIV, across sites in the United States, South Africa, Europe, Asia and Latin America.
Biktarvy is investigational and is being studied across Phase 1, Phase 2 and Phase 3 trials. Its program includes 12 trials in total, with 5 currently active and 6 completed, enrolling 2,973 participants overall. The studies are randomized and controlled, and include a Phase 1 study in newborns exposed to HIV.
Biktarvy trials include NCT06333808, a Phase 3 study comparing bictegravir/lenacapavir with current therapy in people with HIV-1 already treated with Biktarvy, and NCT05502341 (ARTISTRY-1), a Phase 2 comparison in people on a complicated regimen. Other studies include NCT07841990 in HIV-1 and NCT07055451 in newborns exposed to HIV.