A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Latest Information Update: 23 Apr 2024
At a glance
- Drugs Bictegravir/emtricitabine/tenofovir alafenamide (Primary) ; Dolutegravir; Emtricitabine/tenofovir alafenamide
- Indications HIV-1 infections
- Focus Registrational; Therapeutic Use
- Acronyms INFE 5305
- Sponsors Gilead Sciences
- 06 Mar 2024 Results analyzing the effect of ART on selected biomarkers of inflammation and immune activation presented at the 31st Conference on Retroviruses and Opportunistic Infections 2024
- 26 Oct 2022 Results of pooled analysis from Study 1489 and Stduy 1490 assessing 96-week (W) outcomes on bictegravir/emtricitabine/tenofovir alafe-namide (B/F/TAF) in an open-label extension (OLE) that followed144W of blinded DTG-based treatment in two phase III studies ofPWHIV initiating treatment presented at the 16th International Congress on Drug Therapy and HIV Infection
- 24 Oct 2022 According to a Gilead Sciences media release, results from this trial were presented at the 30th International Congress on Drug Therapy in HIV Infection (HIV Glasgow 2022).
Most Recent Events
Trial Overview
Outcome
Purpose
This phase III study is designed to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + a FDC containing emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected, antiretroviral treatment-naive adults at Week 48.
Comments
According to a Gilead Sciences media release, Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), has been approved in China for the treatment of HIV-1 infection, based on the results of 4 trials (1489, 1490, 1844 and 1878).
In March 2019, the Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection.
In 2018, the drug has also been approved by the Hong Kong Department of Health, the U.S. Food and Drug Administration (FDA) and the European Commission.
The approval of Biktarvy is supported by data from four Phase 3 studies (Studies 1489, 1490, 1844 and 1878).
Primary Endpoints
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
description: 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.
time_frame: Week 48 [1]
Other Endpoints
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
description: The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 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.
time_frame: Week 96
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm
description: The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 144 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.
time_frame: Week 144
Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
description: The percentage of participants achieving HIV-1 RNA < 20 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.
time_frame: Week 48
Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
description: The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 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.
time_frame: Week 96
Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm
description: The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 144 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.
time_frame: Week 144
Change From Baseline in log10 HIV-1 RNA at Week 48
time_frame: Baseline, Week 48
Change From Baseline in log10 HIV-1 RNA at Week 96
time_frame: Baseline, Week 96
Change From Baseline in log10 HIV-1 RNA at Week 144
time_frame: Baseline, Week 144
Change From Baseline in CD4+ Cell Count at Week 48
time_frame: Baseline, Week 48
Change From Baseline in CD4+ Cell Count at Week 96
time_frame: Baseline, Week 96
Change From Baseline in CD4+ Cell Count at Week 144
time_frame: Baseline, Week 144
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded Algorithm
description: The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set for the all B/F/TAF analysis. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with nonmissing HIV-1 RNA value at that visit.
time_frame: Baseline, open-label Week 48
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm
description: The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set for the all B/F/TAF analysis. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set.
time_frame: Baseline, open-label Week 48
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm
description: The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set for the all B/F/TAF analysis. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with nonmissing HIV-1 RNA value at that visit.
time_frame: Baseline, open-label Week 96
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm
description: The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set for the all B/F/TAF analysis. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set.
time_frame: Baseline, open-label Week 96
Change From Baseline in CD4+ Cell Count at Week 48 Open-Label
time_frame: Baseline, open-label Week 48
Change From Baseline in CD4+ Cell Count at Week 96 Open-Label
time_frame: Baseline, open-label Week 96 [2]
Diseases Treated
| Indication | Qualifiers | Patient Segments |
|---|---|---|
| HIV-1 infections | treatment | first-line therapy |
Biomarker
| NCT Number | Biomarker Name | Biomarker Function |
|---|---|---|
| NCT02607956 | PITRM1 | Eligibility Criteria |
| T-cell surface antigen CD4 | Outcome Measure |
Subjects
- Subject Type patients
-
Number
Planned: 600
Actual: 645
- Sex male & female
- Age Group 27-46 years; adult
Patient Inclusion Criteria
Key - Antiretroviral treatment naive (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) except the use for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to screening - Plasma HIV-1 ribonucleic acid (RNA) levels ≥ 500 copies per milliliter (mL) at screening - Adequate renal function: Estimated glomerular filtration rate ≥ 30 mL per minute (min) (≥ 0.50 mL per second (sec)) according to the Cockcroft-Gault formula Key
Patient Exclusion Criteria
- An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening - Decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) - Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance - Females who are pregnant (as confirmed by positive serum pregnancy test) - Females who are breastfeeding Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial Details
Identifiers
| Identifier | Owner |
|---|---|
| NCT02607956 | ClinicalTrials.gov: US National Institutes of Health |
| EudraCT2015-003988-10 | European Clinical Trials Database |
| GS-US380-1490 | Gilead Sciences |
| 20692 | United Kingdom Clinical Research Network |
| Study 1490 | - |
| 1490 | - |
Organisations
- Sponsors Gilead Sciences
- Affiliations Gilead Sciences
Trial Dates
-
Initiation Dates
Actual : 11 Nov 2015
-
Primary Completion Dates
Planned : 01 Jun 2017
Actual : 12 May 2017
-
End Dates
Planned : 01 Jun 2021
Actual : 05 Jul 2021
Substudies/Extensions
Optional Pharmacokinetic (PK) Substudy: A PK substudy will be performed at the Week 4 or 8 visit in a subset of subjects (approximately n=30 evaluable) at selected study sites. The substudy will include intensive PK profiling in plasma. Optional Peripheral Blood Mononuclear cell (PBMC) Substudy: A PBMC substudy will be performed at Day 1 and Weeks 36, 84 and 132 in a subset of subjects (target n=50) at select study sites. The substudy will assess HIV-1, PBMC function for HIV disease progression and how the immune system functions in the presence of HIV. Optional pharmacogenomic substudy- For subjects who agree to participate and provide their additional specific consent, three blood samples will be obtained for the extraction of DNA for genomic testing and for potential genotyping to identify polymorphisms of drug metabolism enzymes including Uridine 5'-diphospho-glucuronosyltransferase (UGT1A1) and additional biomarker testing such as such as human leukocyte antigen (HLA). These samples will be collected at Day 1.
Beyond Week 144, study participants will have the option to receive Biktarvy in an open-label extension for up to 96 weeks.
Other Details
- Design double-blind; multicentre; open; parallel; prospective; randomised
- Phase of Trial Phase III
- Location Australia; Belgium; Canada; Dominican Republic; England; France; Germany; Italy; Japan; Puerto Rico; Spain; United Kingdom; USA
- Focus Registrational; Therapeutic Use
Interventions
| Drugs | Route | Formulation |
|---|---|---|
| Bictegravir/emtricitabine/tenofovir alafenamidePrimary Drug | Oral | Tablet |
| Dolutegravir | Oral | Tablet |
| Emtricitabine/tenofovir alafenamide | Oral | Tablet |
DTG + F/TAF
DTG + F/TAF+ B/F/TAF placebo administered without regard to food for at least 144 weeks. Drug: DTG (50 mg tablets administered orally, once daily) Other Name: Tivicay® Drug: F/TAF (200/25 mg tablets administered orally, once daily) Other Name: Descovy® Drug: B/F/TAF Placebo (Tablets administered orally, once daily)
B/F/TAF
B/F/TAF + DTG + F/TAF placebo administered without regard to food for at least 144 weeks. Drug: B/F/TAF (50/200/25 milligrams (mg) FDC tablets administered orally, once daily) Other Name: GS-9883/F/TAF, Biktarvy® Drug: DTG Placebo (Tablets administered orally, once daily) Drug: F/TAF Placebo (Tablets administered orally, once daily)
Open-label Phase B/F/TAF from B/F/TAF
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. Drug: B/F/TAF (50/200/25 milligrams (mg) FDC tablets administered orally, once daily) Other Name: GS-9883/F/TAF, Biktarvy®
Open-label Phase B/F/TAF from DTG + F/TAF
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. Drug: B/F/TAF (50/200/25 milligrams (mg) FDC tablets administered orally, once daily) Other Name: GS-9883/F/TAF, Biktarvy®
Results
Therapeutic efficacy
Pooled analysis: Pooled efficacy data from the phase III 1489 and 1490 trials showed that, at BL, 80 participants had a BL CD4 count < 200 cells/µL and 119 participants had HIV-1 RNA >100,000 c/mL, of whom, 20 had HIV-1 RNA >400,000 c/mL. At W240, virologic suppression was high for the low CD4 count and/or high HIV-1 RNA subgroups. No participant in the final resistance analysis developed virologic resistance to any component of B/F/TAF [3] . Earlier additional findings from the two-phase III trials (studies 1489 and 1490) revealed high efficacy and sustained safety for people switching to the treatment, as well as a high barrier to resistance. These results were reported in participants 96 weeks after switching to open-label Biktarvy after 144 weeks of blinded dolutegravir + 2 NRTIs. At Week 240, more than 99% of participants in both Studies 1489 (217/218; missing=excluded) and 1490 (232/234; missing=excluded) had achieved viral suppression. Furthermore, the study found that after switching to Biktarvy, efficacy was >96% (missing=excluded) at every visit for 240 weeks, demonstrating that Biktarvy may provide sustained viral suppression for people with HIV even after switching treatments [4] . Updated pooled analysis of phase III trials 1489 and 1490 demonstrated that bictegravir/emtricitabine/tenofovir alafenamide sustained efficacy and durable viral suppression as first-line therapy in people with HIV. Additionally, the results from the pooled analysis of both trials showed that 99% of participants who initiated treatment with Biktarvy and remained in the study for all 240 weeks achieved and maintained an undetectable viral load (HIV-1 RNA <50 copies/mL) through five years of follow-up (Week 240, 1489: n=208/213; 1490: n=218/219, missing equals excluded analysis). In addition to high rates of virologic suppression, participants achieved a median increase in CD4 count of 317 cells/µl from baseline at week 240. The findings demonstrated minimal impact on bone mineral density (BMD) outcomes through five years. Mean percentage changes in hip and spine BMD through week 240 in Biktarvy participants did not exceed -0.6% [5] . Previous updated pooled analysis of phase III trials 1489 and 1490 demonstrated that the efficacy was >98% after week 48 at each study visit through week 240 in both studies. No resistance to components of bictegravir/emtricitabine/tenofovir alafenamide was detected in the resistance analysis population. Among bictegravir/emtricitabine/tenofovir alafenamide participants through week 240, median changes in eGFR were -8.2 mL/min (1489) and -8.5 mL/min (1490), median change in TC:HDL ratio were 0 (1489) and 0.1 (1490). Median change in weight from baseline to week 240 was 6.1kg in bictegravir/emtricitabine/tenofovir alafenamide participants, median weight change for comparators at week 144 was 3.5kg (1489) and 5.0kg (1490), with 2.4kg and 1.3kg additional gains observed between week 144 to week 240, respectively. Mean percentage changes (SD) in hip and spine bone mineral density (BMD) through week 240 in bictegravir/emtricitabine/tenofovir alafenamide participants were -0.29% (5.29) and -0.23% (5.16), respectively [6] . Earlier results showed that in both studies >98% of participants who initiated treatment with therapy bictegravir/emtricitabine/tenofovir alafenamide and remained in the study achieved and maintained an undetectable viral load (HIV-1 RNA <50 copies/mL) at four years of follow-up (n=235/237 for study 1489, n=241/243 for study 1490). The high efficacy and durable viral suppression were also observed in participants who switched to therapy bictegravir/emtricitabine/tenofovir alafenamide from a dolutegravir-containing triple therapy for the 48-week OLE periods (n=212 for study 1489, n=225 for study 1490). No treatment-emergent resistance to any components of the therapy occurred in participants treated with therapy bictegravir/emtricitabine/tenofovir alafenamide. The data from a 144 week analysis demonstrated that people living with HIV who received initial therapy with combination reached and maintained an undetectable viral load with no treatment-emergent resistance through 144 weeks (n=634). In a subgroup analysis of participants with transmitted drug resistance (TDR, n=248) based on retrospective sequencing from the baseline, combination therapy achieved comparably high levels of durable viral suppression through 144 weeks among participants with and without TDR (98% vs. 97%; as treated analysis). The data showed that of the 1240 patients who had shown confirmed suppression, 143 (11.5%) had 1 blip through week 144 with similar blip frequencies between treatment arms. Per study, an average of 1.3% of participants experienced blips. In 143 patients, total of 186 blip events were observed, 110 experienced a single blip and 33 experienced multiple blips. Of the 186 blips, 87 (46.8%) were low-level (50-199 c/mL) and 99 (53.2%) were 200 c/mL. Similarity was observed for proportions of participants with blips <200 c/mL or 200 c/mL. Most patients with blips 200 c/mL showed adherence 95% by pill count (69.2%), while those with blips <200 c/mL mostly showed adherence >95% (63.1%). Of participants without blips, 98.7% (1083/1097) showed HIV RNA <50 c/mL at week 144 or last visit versus, 91.0% (71/78) with blips 200 c/mL (p<0.01), or versus 96.9% (63/65) with blips <200 c/mL (P = 0.2). At week 144, 7 with blips 200 c/mL and HIV RNA 50 c/mL were on DTG-based regimens, and 6/7 had evidence of continued low adherence. Of 21 patients who underwent overall resistant analysis population, five patients showed blips [7] [8] . Results from the pooled analysis of nine Phase III randomized studies in treatment-naïve and virologically suppressed people with HIV who were restarting treatment with Biktarvy after experiencing virologic rebound showed that out of the total participants (3,772), 2.5% (96/3,772) experienced virologic rebound, resulting in 110 virologic rebound events. Virologic rebound events were defined as having a viral load of 1,000 copies per mL or higher after achieving virologic suppression. When excluding events where the outcome could not be evaluated due to the rebound occurring at the last assessment, the resuppression rate was 93% (91/98).The study found that the majority of participants who experienced virologic rebound achieved viral resuppression within 30 days after regaining virologic control. No instances of treatment-emergent resistance were observed in participants with persistent viremia. These findings support the ongoing evaluation of Biktarvy as a potential treatment option for individuals with viremia who had previously achieved virologically suppressed and restarting treatment.
Pooled four year follow-up results of the two phase III trials (study 1489 and study 1490) in HIV-infected antiretroviral treatment-naive patients showed that in study 1489, baseline (BL) prevalence of diabetes (DM) and hypertension (HTN) was 4.5 and 12.1% with treatment-emergent (TE) DM and HTN in bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) being 0.7% and 10%, and for dolutegravir/abacavir/ lamivudine (DTG/ABC/3TC) 1.3% and 6.9%, respectively. In study 1490, BL prevalence of DM and HTN was 6.8 and 18.8% with TE DM and HTN in B/F/TAF being 2.1 and 5.8%, and for DTG+F/TAF 2.3 and 6.5%, respectively. BMI shift from Normal to Obese: B/F/TAF 0%, DTG/ABC/3TC 3.2%, p=0.12 (1489). B/F/TAF 2.5%, DTG+F/TAF 2.9% p=1.00 (1490). Subgroup analyses by gender/race showed similar findings for TE DM, HTN, and BMI changes. Median changes from BL fasted lipids were small [9] . Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) was highly efficacious. Similar outcomes were demonstrated in participants who switched from dlutegravir/ abacavir/lamivudine (DTG/ABC/3TC)-containing regimens to B/F/TAF. The efficacy was >98% after week 48 at each study visit through week 192 in both studies. In participants initially randomised to B/F/TAF, the median change in weight from baseline to week 192 was 4.6 kg in study 1490 and 5.0 kg in study 1490. The mean percent changes (SD) in hip and spine bone mineral density (BMD) through week 192 were -1.5% (4.9) and -0.9% (5.2), respectively. At week 192, 13% of participants with baseline osteopenia in hip and 3% with osteopenia of the spine improved to normal, 4% with normal baseline hip and 6% with normal baseline spine BMD progressed to osteopenia and none developed osteoporosis [10] . Updated results from two phase III trial (study 1489 and study 1490) demonstrated that treatment with bictegravir/emtricitabine/ tenofovir (B/F/TAF) achieved high rates of viral suppression. Treatment outcomes by last on-treatment observation carried forward at week 144 for participants with and without transmitted drug resistance (TDR) was comparable (98% of those with primary TDR had HIV RNA <50 copies/mL vs. 97% of those without TDR). One participant had preexisting Q148H+G140S in IN and K70R and K103N in RT at baseline. This participant was randomized to B/F/TAF, had HIV-1 RNA <50 copies/mL at week 4 and maintained HIV-1 RNA <50 copies/mL through week 144. Out of 21 participants qualified for post-baseline resistance testing, 2/8 receiving B/F/TAF, 6/6 receiving dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) and 4/7 receiving dolutegravir + emtricitabine/tenofovir (DTG + F/TAF) participants had multiple confirmed virologic rebounds during the studies. No participant had emergent resistance to study drugs [11] . Earlier results from the trials showed that through 144 weeks of therapy bictegravir/emtricitabine/tenofovir alafenamide was well-tolerated and demonstrated high rates of virologic suppression. At Week 144, non-inferiority was maintained from the primary endpoint measurement in both studies at Week 48, with a similar proportion of the Biktarvy group achieving virologic suppression (82 percent; n=518/634) as those taking DTG/ABC/3TC (84 percent; n=265/315) and DTG + F/TAF (84 percent; n=273/325). Across all treatment groups no participants developed treatment failure with treatment-emergent resistance. There were no discontinuations due to renal events and no cases of proximal renal tubulopathy or Fanconi syndrome in the Biktarvy treatment group. Similar reductions in median estimated glomerular filtration rate (eGFR) were observed across groups (-9.2 mL/min in patients taking Biktarvy vs. -11.7 mL/min in participants taking ABC/DTG/3TC versus -11.0 mL/min in participants taking DTG + F/TAF) at Week 144. Study 1489 also assessed other laboratory markers of renal and bone safety in patients taking Biktarvy and DTG/ABC/3TC. Participants in both treatment arms demonstrated similar median changes in proteinuria and mean percentage changes in hip and spine bone mineral density (BMD) from baseline. Small, statistically significant differences in the median change from baseline favoring DTG/ABC/3TC were observed for LDL, HDL and total cholesterol to HDL ratio [12] .
Results from a phase III trial (Study 1490) demonstrated high efficacy and high barrier to resistance of bictegravir/emtricitabine/tenofovir alafenamide through 96 weeks. At week 96, non-inferiority was maintained from the primary endpoint measurement at week 48, with 84.1% (n=269/320) of patients taking bictegravir/emtricitabine/tenofovir alafenamide and 86.5% (n=281/325) of patients taking dolutegravir plus emtricitabine/tenofovir alafenamide achieving HIV-1 RNA levels less than 50 copies/mL (difference: -2.3%, 95% CI: -7.9% to 3.2%, p=0.41). Earlier, in the trial, it was reported that at week 48, 89% (286/320) of patients taking bictegravir/emtricitabine/tenofovir alafenamide (50/200/25mg) tablets and 92% (n=302/325) of patients taking dolutegravir plus emtricitabine/tenofovir alafenamide achieved the primary endpoint of HIV-1 RNA levels less than 50 copies/mL (difference: -3.5%, 95% CI: -7.9% to 1.0%, p=0.12). No patients in either treatment arm developed treatment-emergent resistance to any of the study drugs. Lipid changes were not significantly different between the two arms. The trial randomised 645 treatment-naïve adults with HIV to receive bictegravir/emtricitabine/tenofovir alafenamide or dolutegravir plus emtricitabine/tenofovir alafenamide [13] [14] .
Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) 50mg/200mg/25mg met the primary endpoint of non-inferiority in all four phase III studies, with comparable proportions of patients having HIV-1 RNA < 50 copies/mL (Studies 1489 and 1490) and HIV-1 RNA ≥ 50 copies/mL (Studies 1844 and 1878). One patient randomised to the protease inhibitor arm in Study 1878 developed an abacavir resistance mutation (L74V). No patients randomised to the bictegravir or dolutegravir arms developed treatment-emergent resistance [1] .
Adverse events
Pooled safety data from the phase III 1489 and 1490 trials showed that, across the subgroups, the most common DRAEs were nausea, headache and diarrhea and there were no serious DRAEs. There was only one discontinuation due to a DRAE in the low CD4 count subgroup, and none in the high HIV-1 RNA subgroup [3] . Earlier, pooled safety data phase III 1489 and 1490 trials showed that no cases of treatment failure due to emergent resistance were detected. Across both studies, 10 patients (n=10/634) experienced a study-drug-related AE that led to drug discontinuation [5] . Earlier, pooled analysis of phase III trials 1489 and 1490 demonstrated that bictegravir/emtricitabine/tenofovir alafenamide was generally safe and well tolerated. During the open label extension, 6/504 bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) participants experienced an adverse event (AE) that led to drug discontinuation. None were related to renal. ≤1.6% had a Grade 3 or 4 drug-related AE. Earlier results showed that the most common adverse events (AEs) in adults of 50 years of age in patients receiving B/F/TAF, DTG/ABC/3TC, 325 DTG + F/TAF were nasopharyngitis (20%, 22%, 25%), diarrhea (19%, 22%, 8%), and upper respiratory tract infection (16%, 17%, 12%), respectively. The most common AEs in adults of <50 years of age were diarrhea (19%, 18%, 18%), headache (17%, 18%, 19%), and nausea (11%, 26%, 15%). Treatment-related AEs occurred in 24%, 37%, and 29% of participants the frequency was 26%, 43% and 29% in participants <50 years (p < 0.001 for B/F/TAF vs DTG/ABC/3TC). Most treatment related AEs were grade 1. 50 patients discontinued due to AEs, 2% on B/F/TAF, 5% on DTG/ABC/3TC and 7% on DTG + F/TAF compared to 1% in each treatment group for participants <50 years. Among 50 with AEs leading to discontinuation, 1 on B/F/TAF, 1 on DTG/ABC/3TC and 3 on DTG+F/TAF were treatment-related. 1274 were randomised and treated (634 Bictegravir/emtricitabine/tenofovir alafenamide [B/F/TAF], 315 Abacavir/Dolutegravir/Lamivudine [DTG/ABC/3TC], 325 Dolutegravir + Emtricitabine/Tenofovir Alafenamide[DTG + F/TAF]) [6] [15] .
Additional findings from the two phase III trials (studies 1489 and 1490) showed that Biktarvy was generally well tolerated, with 0.4% (2/519) of switch participants in both studies experiencing an adverse event that resulted in drug discontinuation during the open-label extension period. There were no renal withdrawals. During the open-label extension phase, the most commonly reported adverse events were diarrhoea (0.6%) and weight change (0.6%) [4] . Pooled four year follow-up results of the two phase III trials (study 1489 and study 1490) in HIV-infected antiretroviral treatment-naive patients showed long-term safety profile of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF). Across both studies, only one participant experienced an adverse events (AE) that led to drug discontinuation during the open-label extension (OLE) analysis window. Grade 3 or 4 drug-related AEs were rare. There were no discontinuations due to renal AEs [10] . Updated results from two phase III trials (Study 1489 and Study 1490) in patients with HIV-1 infections showed that through 144 weeks of therapy bictegravir/emtricitabine/tenofovir alafenamide was well-tolerated. Discontinuations due to adverse events were low across all groups (1% (n=6/634) for Biktarvy versus 2% (n=5/315) for DTG/ABC/3TC and 2% (n=6/325) for DTG + F/TAF). The proportion of drug-related adverse events (all grades) was 26% in the Biktarvy arm (n=165/634) versus 42% (n=132/315) for DTG/ABC/3TC and 29% (n=94/325) for DTG + F/TAF). The incidence of drug related nausea was 4% for Biktarvy versus 18% for DTG/ABC/3TC and 5% for DTG + F/TAF (p<0.0001 for Biktarvy versus DTG/ABC/3TC). The most commonly reported treatment-emergent adverse events (all grades) were diarrhoea (19% for Biktarvy versus 18% for DTG/ABC/3TC and 16% for DTG + F/TAF), headache (16% for Biktarvy versus 18% for DTG/ABC/3TC and 18% for DTG + F/TAF) and nasopharyngitis (14% for Biktarvy versus 17% for DTG/ABC/3TC and 19% for DTG + F/TAF) [12] .
Updated results from a phase III trial (study 1490) demonstrated, patients (n=5/634) experienced a study-drug related adverse event (AE) that led to drug discontinuation. Earlier, in a phase III trial (Study 1490), bictegravir/emtricitabine/tenofovir alafenamide was well-tolerated with low discontinuations due to adverse events in both treatment arms (2% (n=6) versus 2% (n=5) [1 bictegravir/emtricitabine/tenofovir alafenamide and 4 dolutegravir plus emtricitabine/tenofovir alafenamide, after week 48]). The most commonly reported adverse events (all grades) were diarrhoea (18% versus 16%) and headache (16% versus 15%). There were fewer treatment-related adverse events (all grades) in the treatment arm, compared with dolutegravir plus emtricitabine/tenofovir alafenamide (20% versus 28%). Lipid changes were not significantly different between the two arms, and there were no renal discontinuations or cases of proximal renal tubulopathy. Earlier, it was reported that the most commonly reported adverse events with bictegravir/emtricitabine/tenofovir alafenamide and dolutegravir plus emtricitabine/tenofovir alafenamide were headache (13% versus 12%) and diarrhoea (12% versus 12%), respectively. There were no renal discontinuations or cases of proximal renal tubulopathy. Discontinuations due to adverse events were low in both treatment arms. The trial randomised 645 treatment-naïve adults with HIV to receive bictegravir/emtricitabine/tenofovir alafenamide or dolutegravir plus emtricitabine/tenofovir alafenamide [16] [13] [14] .
In four phase III studies (Studies 1489, 1490, 1844 and 1878), bictegravir/emtricitabine/tenofovir alafenamide 50mg/200mg/25mg was well tolerated. Treatment-emergent virological resistance was not seen. No patients discontinued study medication due to renal events and no cases of proximal renal tubulopathy or Fanconi syndrome were observed. Diarrhoea, nausea and headache were the most common adverse reactions [1] .
Publications
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Gilead Sciences. Gileads Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for the Treatment of HIV-1 Meets Primary Endpoint in Four Phase 3 Studies. Media-Rel 2017;.
Media Release -
Ramgopal M, Wurapa A, Baumgarten A, Berhe M, Pozniak A, Orkin C, et al. 5-year outcomes of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) as initial treatment of HIV-1 in adults with high baseline HIV-1 RNA and/or low CD4 count in two Phase 3 randomized clinical trials. IDW-2022 2022; abstr. 1251.
Available from: URL: https://academic.oup.com/ofid/article/9/Supplement_2/ofac492.1082/6903025 -
Gilead Sciences. Gilead Presents Real-World Evidence Reinforcing the Use of Biktarvy(Rm) for the Treatment of People Living With HIV With a Range of Comorbidities. Media-Rel 2022;.
Media Release -
Gilead Sciences. Biktarvy(Rm) Demonstrates High Efficacy for a Broad Range of People Initiating Treatment for HIV, Including Those With HBV Coinfection. Media-Rel 2022;.
Media Release -
Wohl DA, Pozniak A, Workowski K, Hagins D, Daar ES, Orkin CL, et al. B/F/Taf Five-Year Outcomes in Treatment-Naive Adults. CROI-2022 2022; abstr. 494.
Available from: URL: http://www.croiconference.org/ -
Gilead Sciences. Biktarvy(Rm) Demonstrates High Efficacy and Durable Viral Suppression in Treatment-Nave Adults in Four-Year Data Presented at CROI. Media-Rel 2021;.
Media Release -
Acosta RK, Andreatta K, D'Antoni ML, Collins SE, Martin H, White KL. HIV VIRAL BLIPS IN ADULTS TREATED WITH InSTI-BASED REGIMENS THROUGH 144 WEEKS. CROI-2020 2020; abstr. 540.
Available from: URL: http://www.croiconference.org/sessions/hiv-viral-blips-adults-treated-insti-based-regimens-through-144-weeks -
Daar E, Orkin C, Sax P, Stephens JL, Koenig E, Clarke A, et al. Incidence of metabolic complications among treatment-naive adults living with HIV-1 randomized to B/F/TAF, DTG/ABC/3TC or DTG+F/TAF after 144 Weeks. IDW-2021 2021; abstr. 69.
Available from: URL: https://academic.oup.com/ofid/article/8/Supplement_1/S46/6449548 -
Workowski K, Orkin C, Sax P, Hagins D, Koenig E, Stephens J, et al. 4-Year Outcomes of B/F/Taf in Treatment-Naive Adults. CROI-2021 2021; abstr. 415.
Available from: URL: http://www.croiconference.org/ -
Acosta RK, Chen GQ, Chang S, Martin R, Wang X, Huang H, et al. Hiv with Transmitted Drug Resistance is Durably Suppressed by B/F/Taf at Week 144. CROI-2021 2021; abstr. 430.
Available from: URL: http://www.croiconference.org/ -
Gilead Sciences. Gileads Biktarvy Maintained High Efficacy With No Cases of Treatment-Emergent Resistance Through Three Years in Phase 3 HIV Clinical Trials. Media-Rel 2019;.
Media Release -
Gilead Sciences. Gilead Announces 96-Week Results From Phase 3 Study of Biktarvy(Rm) (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 in Adults New to HIV Therapy- 30 October 2018. Media-Rel 2018;.
Media Release -
Gilead Sciences. Gilead Announces Phase 3 Results for Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV. Media-Rel 2017;.
Media Release -
Mills A, Gupta SK, Brinson C, Workowski K, Clarke A, Antinori A, et al. -- please add a title --. CROI-2020 2020; abstr. 477.
Available from: URL: http://www.croiconference.org/sessions/144-week-efficacy-and-safety-bftaf-treatment-naive-adults-%E2%89%A550-yrs -
Gilead Sciences. Biktarvy(Rm) Demonstrates High Efficacy and Durable Viral Suppression at Five Years, in Treatment-Nave Adults. Media-Rel 2022;.
Media Release -
White KL, Kulkarni R, Willkom M, Martin R, Chang S, Wei X, et al. Pooled Week 48 Efficacy and Baseline Resistance: B/F/Taf in Treatment-Naive Patients. CROI-2018 2018; abstr. 532.
Available from: URL: http://www.croiconference.org/sessions/pooled-week-48-efficacy-and-baseline-resistance-bftaf-treatment-naive-patients -
Acosta R, Andreatta K, D?Antoni M, Collins S, Martin H, White K. Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) shows high efficacy in clinical study participants infected with HIV-1 subtype F. ICDTHI-2020 2020; abstr. P124.
Available from: URL: http://www.hivglasgow.org/ -
Orkin C, Sax PE, Arribas J, Gupta S, Martorell C, Stephens JL, et al. Long-term efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in ART-naive adults. EACS-2019 2019; abstr. PE3/14.
Available from: URL: http://www.professionalabstracts.com/eacs2019/iplanner/#/list -
Podzamczer D, Stellbrink H, Orkin C, Pozniak A, Arribas J, Koenig E, et al. B/F/TAF versus ABC/DTG/3TC or DTG + F/TAF in treatment?naive adults with high baseline viral load or low baseline CD4 count in two Phase III randomized, controlled clinical trials: Week 96 results. ICDTHI-2018 2018; abstr. P119.
Available from: URL: https://onlinelibrary.wiley.com/doi/10.1002/jia2.25187 -
Gilead Sciences. Four-Year Biktarvy(Rm) Data Presented at IAS 2021 Demonstrate High Efficacy and Durable Viral Suppression in Treatment-Nave Adults. Media-Rel 2021;.
Media Release -
Orkin C, Antinori A, Rockstroh J, Guillen SM, Martorell C, Molina J, et al. Outcomes after switching from 144 weeks of blinded DTG/ABC/3TC or DTG+F/TAF to 96 weeks of open-label B/F/TAF. ICDTHI-2022 2022; abstr. P088.
Available from: URL: http://www.hivglasgow.org/ -
Andreatta K, Sax PE, Wohl DA, D?Antoni ML, Huang H, Hindman J, et al. Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) Versus Dolutegravir (DTG)-Based 3-Drug Regimens in Adults With HIV Who Have Suboptimal Antiretroviral Adherence. IDW-2023 2023; abstr. 1561.
Available from: URL: https://academic.oup.com/ofid/article/10/Supplement_2/ofad500.1396/7446554 -
Sax PE, Erlandson KM, Lake JE, McComsey GA, Orkin C, Esser S, et al. Weight Gain Following Initiation of Antiretroviral Therapy: Risk Factors in Randomized Comparative Clinical Trials. Clin-Infect-Dis 2019;.
PubMed | CrossRef Fulltext -
Funderburg N, Huang SS, Cohen C, Ailstock K, Lee J, Ng B, et al. Inflammatory Profile of B/F/TAF, DTG/ABC/3TC, and DTG+F/TAF Over 5 Years and Effects of Viral Blips. CROI-2024 2024; abstr. 818.
Available from: URL: https://www.croiconference.org/abstract/inflammatory-profile-of-b-f-taf-dtg-abc-3tc-and-dtgf-taf-over-5-years-and-effects-of-viral-blips/ -
Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380?1490): a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Internet-Doc 2017;.
Available from: URL: http://link.adisinsight.com/g2X7Z -
Podzamczer D, Stellbrink H-J, Orkin C, Pozniak A, Arribas JR, Koenig E, et al. B/F/TAF versus ABC/DTG/3TC or DTG + F/TAF in treatment-naive adults with high baseline viral load or low baseline CD4 count in 2 Phase 3 randomized, controlled clinical trials. AIDS-2018 2018; abstr. THPEB038.
Available from: URL: http://programme.aids2018.org/Abstract/Abstract/5126 -
Orkin C, Kityo C, Koenig E, Natukunda E, Ajana F, Gandhi-Patel B, et al. Efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide vs comparators in cis-women and girls (living with HIV): an analysis of 5 clinical trials. EACS-2019 2019; abstr. PS7/6.
Available from: URL: http://www.professionalabstracts.com/eacs2019/iplanner/#/list -
Pozniak A, Maggiolo F, Podzamczer D, Yazdanpanah Y, Gupta S, Esser S, et al. Outcomes 48 weeks after switching from DTG/ABC/3TC or DTG+F/TAF to B/F/TAF. EACS-2021 2021; abstr. PE2/68.
Available from: URL: https://eacs-conference2021.com/ -
Orkin C, Ajana F, Kityo C, Koenig E, Natukunda E, Gandhi-Patel B, et al. Efficacy and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Females Living With HIV: An Integrated Analysis of 5 Trials. . J-Acquir-Immune-Defic-Syndr 2021;.
PubMed | CrossRef Fulltext -
Acosta R, Willkom M, Martin R, Chang S, Liu X, Hedskog C, et al. Low-frequency resistance variants in ART-naive participants do not affect bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) triple therapy treatment outcome. IAS-2019 2019; abstr. MOPEB242.
Available from: URL: http://programme.ias2019.org/Abstract/Abstract/3778 -
Acosta RK, Willkom M, Martin R, Chang S, Wei X, Garner W, et al. Resistance Analysis of Bictegravir/Emtricitabine/Tenofovir Alafenamide in HIV-1 Treatment-Naive Patients Through 48 Weeks. Antimicrob-Agents-Chemother 2019;.
PubMed | CrossRef Fulltext -
Stellbrink H, Arribas J, Stephens J, Albrecht H, Sax P, Maggiolo F, et al. Phase III randomized, controlled clinical trial of bictegravir coformulated with FTC/TAF in a fixed?dose combination (B/F/TAF) versus dolutegravir (DTG) + F/TAF in treatment?naive HIV?1 positive adults: Week 96. ICDTHI-2018 2018; abstr. O211.
Available from: URL: https://onlinelibrary.wiley.com/doi/10.1002/jia2.25187 -
Acosta RK, Chen GQ, Qin L, Wang X, Huang H, Hindman J, et al. Achievement of undetectable HIV-1 RNA in the B/F/TAF treatment-naive clinical trials. IAS-2021 2021; abstr. PEB150.
Available from: URL: https://www.ias2021.org/ -
Rockstroh JK, Sax PE, Daar E, Walmsley S, Workowski K, Orkin C, et al. High Hbv and Hiv Suppression with Treatment of Hiv/Hbv Coinfection in B/F/Taf Studies. CROI-2018 2018; abstr. 618.
Available from: URL: http://www.croiconference.org/sessions/high-hbv-and-hiv-suppression-treatment-hivhbv-coinfection-bftaf-studies -
Acosta R, White K, Garner W, Wei X, Andreatta K, Willkom M, et al. HIV-1 subtype (B or non-B) had no impact on the efficacy of B/F/TAF or resistance development in five phase 3 treatment-naIve or switch studies. AIDS-2018 2018; abstr. THPEB077.
Available from: URL: http://programme.aids2018.org/Abstract/Abstract/11607 -
Gilead Sciences. New Data on Gileads Biktarvy(Rm) Presented at CROI 2020, Including Data in Black Americans and Older Adults. Media-Rel 2020;.
Media Release -
D'Antoni ML, Andreatta K, Acosta R, Martin H, Chang S, Martin R, et al. Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) Efficacy in Participants with Pre-existing Primary Integrase Inhibitor Resistance Through 48 Weeks of Phase 3 Clinical Trials. J-Acquir-Immune-Defic-Syndr 2021;.
PubMed | CrossRef Fulltext -
Arribas J, Orkin C, Maggiolo F, Antinori A, Lazzarin A, Yazdanpanah Y, et al. Long-term analysis of B/F/TAF in treatment-naive adults living with HIV through four years of follow-up. IAS-2021 2021; abstr. PEB151.
Available from: URL: https://www.ias2021.org/ -
Acosta RK, Chen GQ, Chang S, Martin R, Wang X, Huang H, et al. Three-year study of pre-existing drug resistance substitutions and efficacy of bictegravir/emtricitabine/tenofovir alafenamide in HIV-1 treatment-naive participants. . J-Antimicrob-Chemother 2021;.
PubMed | CrossRef Fulltext -
Sax P, Arribas J, Orkin C, Lazzarin A, Pozniak A, DeJesus E, et al. Long-term integrated analysis of B/F/TAF in treatment-naive adults with HIV through five years of follow-up. AIDS-2022 2022; abstr. EPB150.
Available from: URL: https://programme.aids2022.org/Abstract/Abstract/?abstractid=5471 -
Gilead Sciences. Gilead Presents New Data on Biktarvy(Rm) (Bictegravir, Emtricitabine and Tenofovir Alafenamide) and TAF-Based Regimens for the Treatment of HIV-1 in Children, Older Adults and Women. Media-Rel 2019;.
Media Release -
Gupta SK, Mills A, Brinson C, Workowski K, Clarke A, Antinori A, et al. -- please add a title --. CROI-2019 2019; abstr. 502.
Available from: URL: http://www.croiconference.org/sessions/96-week-efficacy-and-safety-bftaf-treatment-na%C3%AFve-adults-and-adults-%E2%89%A550-yrs -
Sax PE, Pozniak A, Arribas J, Koenig E, Dejesus E, Stellbrink H-J, et al. Phase 3 randomized, controlled clinical trial of bictegravir coformulated with FTC/TAF in a fixed-dose combination (B/F/TAF) vs dolutegravir (DTG) + F/TAF in treatment-naive HIV-1 positive adults: week 48 results. IAS-2017 2017; abstr. TUPDB0201LB.
Available from: URL: http://programme.ias2017.org/Abstract/Abstract/5793
Trial Centres
Investigators
| Investigator | Centre Name | Trial Centre Country |
|---|---|---|
| Devi SenGupta, MD | Gilead Sciences |
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| Gilead Study Director | Gilead Sciences |
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Centres
| Centre Name | Location | Trial Centre Country |
|---|---|---|
| - | Albany, New York | USA |
| - | Alicante | Spain |
| - | Annandale, Virginia | USA |
| - | Antwerp | Belgium |
| - | Atlanta, Georgia | USA |
| - | Austin, Texas | USA |
| - | Badalona | Spain |
| - | Bellaire, Texas | USA |
| - | Bergamo | Italy |
| - | Berkley, Michigan | USA |
| - | Berlin | Germany |
| - | Beverly Hills, California | USA |
| - | Birmingham | United-Kingdom |
| - | Boston, Massachusetts | USA |
| - | Bronx, New York | USA |
| - | Carlton, Victoria | Australia |
| - | Chapel Hill, North Carolina | USA |
| - | Charlotte, North Carolina | USA |
| - | Chicago, Illinois | USA |
| - | Cincinnati, Ohio | USA |
| - | Clayton, Victoria | Australia |
| - | Columbia, South Carolina | USA |
| - | Düsseldorf | Germany |
| - | Dallas, Texas | USA |
| - | Decatur, Georgia | USA |
| - | DeLand, Florida | USA |
| - | Denver, Colorado | USA |
| - | Detroit, Michigan | USA |
| - | Essen | Germany |
| - | Fort Lauderdale, Florida | USA |
| - | Fort Pierce, Florida | USA |
| - | Fort Worth, Texas | USA |
| - | Frankfurt | Germany |
| - | Ghent | Belgium |
| - | Greenville, North Carolina | USA |
| - | Hamburg | Germany |
| - | Hillsborough, New Jersey | USA |
| - | Houston, Texas | USA |
| - | Huntersville, North Carolina | USA |
| - | Indianapolis, Indiana | USA |
| - | Kansas City, Missouri | USA |
| - | London | United-Kingdom |
| - | Longview, Texas | USA |
| - | Los Angeles, California | USA |
| - | München | Germany |
| - | Macon, Georgia | USA |
| - | Madrid | Spain |
| - | Malaga | Spain |
| - | Manchester | United-Kingdom |
| - | Manhasset, New York | USA |
| - | Melbourne, Victoria | Australia |
| - | Miami, Florida | USA |
| - | Miami Beach, Florida | USA |
| - | Milano | Italy |
| - | Montpellier | France |
| - | New York, New York | USA |
| - | Newark, New Jersey | USA |
| - | Oakland Park, Florida | USA |
| - | Orlando, Florida | USA |
| - | Ottawa | Canada |
| - | Pensacola, Florida | USA |
| - | Philadelphia, Pennsylvania | USA |
| - | Phoenix, Arizona | USA |
| - | Prahran, Victoria | Australia |
| - | Roma | Italy |
| - | Sacramento, California | USA |
| - | Saint Louis, Missouri | USA |
| - | San Juan | Puerto-Rico |
| - | Santo Domingo | Dominican-Republic |
| - | Savannah, Georgia | USA |
| - | Seattle, Washington | USA |
| - | Spokane, Washington | USA |
| - | Springfield, Massachusetts | USA |
| - | Sydney, New South Wales | Australia |
| - | Tampa, Florida | USA |
| - | Toronto | Canada |
| - | Tourcoing | France |
| - | Vigo | Spain |
| - | Washington, District of Columbia | USA |
| - | West Palm Beach, Florida | USA |
| - | Winnipeg | Canada |
| - | Winston-Salem, North Carolina | USA |
| AIDS Arms Inc | Dallas, Texas | USA |
| Allegheny Health Network | Pittsburgh, Pennsylvania | USA |
| Chelsea and Westminster NHS Trust | London | United-Kingdom |
| CHU de Nice Archet I | Nice | France |
| Cone Health Regional Center for Infectious Disease | Greensboro, North Carolina | USA |
| Gilead Sciences |
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|
-
|
| Gilead Sciences |
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|
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|
| Gilead Sciences, Inc. |
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|
USA |
| Hospital Universitario Ramon y Cajal | Madrid | Spain |
| Kaiser Permanente | San Leandro, California | USA |
| McGill University Health Center | Montreal | Canada |
| North Texas Infectious Diseases Consultants PA | Dallas, Texas | USA |
| Optimus Medical - ClinEdge - PPDS | San Francisco, California | USA |
| Prahran Market Clinic | Prahran, Victoria | Australia |
| Sinai Hospital of Baltimore | Baltimore, Maryland | USA |
| St George's Healthcare NHS Trust | London | United-Kingdom |
| Sunnybrook Health Sciences Centre | Toronto | Canada |
| Uniklinik Köln | Köln | Germany |
Trial History
| Event Date | Event Type | Comment |
|---|---|---|
| 06 Mar 2024 | Results | Results analyzing the effect of ART on selected biomarkers of inflammation and immune activation presented at the 31st Conference on Retroviruses and Opportunistic Infections 2024 Updated 23 Apr 2024 |
| 15 Oct 2023 | Results | Results of pooled analysis from /F/TAF Studies 1489, 1490, 4458, 1844 and 4030 presented at the IDWeek 2023 Updated 05 Feb 2024 |
| 26 Oct 2022 | Results | Results of pooled analysis from Study 1489 and Stduy 1490 assessing 96-week (W) outcomes on bictegravir/emtricitabine/tenofovir alafe-namide (B/F/TAF) in an open-label extension (OLE) that followed144W of blinded DTG-based treatment in two phase III studies ofPWHIV initiating treatment presented at the 16th International Congress on Drug Therapy and HIV Infection Updated 16 Dec 2022 |
| 24 Oct 2022 | Results | According to a Gilead Sciences media release, results from this trial were presented at the 30th International Congress on Drug Therapy in HIV Infection (HIV Glasgow 2022). Updated 28 Oct 2022 |
| 24 Oct 2022 | Results | Results published in the Gilead Sciences Media Release. Updated 28 Oct 2022 |
| 23 Oct 2022 | Results | Results of long-term outcomes over 5-years from selected sub-groups presented at the IDWeek 2022 Updated 02 Feb 2023 |
| 18 Oct 2022 | Other trial event | According to a Gilead Sciences media release, data from this study to be presented at the 30th International Congress on Drug Therapy in HIV Infection (HIV Glasgow 2022). Updated 21 Oct 2022 |
| 02 Aug 2022 | Results | Results assessing long-term integrated analysis of B/F/TAF in treatment-naive adults with HIV through five years of follow-up presented at the 24th International AIDS Conference Updated 07 Sep 2022 |
| 28 Jul 2022 | Results | According to a Gilead Sciences Media Release, 5-year data from this trial were presented at the 24th International AIDS Conference (AIDS 2022). Updated 01 Aug 2022 |
| 28 Jul 2022 | Results | Pooled analysis results from Study 1489 and 1490 published in the Gilead Sciences Media Release. Updated 01 Aug 2022 |
| 25 Jul 2022 | Other trial event | Last checked against European Clinical Trials Database record. Updated 25 Jul 2022 |
| 09 Mar 2022 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 09 Mar 2022 |
| 16 Feb 2022 | Results | Results of 5-year cumulative outcomes of B/F/TAF in treatment-naive PWH from Study 1489 and Study 1490, presented at the 29th Conference on Retroviruses and Opportunistic Infections Updated 25 Mar 2022 |
| 11 Feb 2022 | Results | According to a Gilead Sciences Media Release, cumulative 5-year results from two Phase 3 studies (Study 1489 and Study 1490), presented at the 29th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2022). Updated 15 Feb 2022 |
| 11 Feb 2022 | Results | Results presented in the Gilead Sciences Media Release. Updated 15 Feb 2022 |
| 10 Dec 2021 | Results | Results of pooled analysis (n=1906) assessing virologic outcomes through 48 weeks of B/F/TAF treatment in individuals with pre-existing primary INSTI-R from 7 bictegravir/emtricitabine/tenofovir alafenamide studies (GS-US-380-1489/NCT02607930 and GS-US-380-1490/NCT02607956), (GS-US-380-1844/NCT02603120; GS-US-380-1878/NCT02603107; GS-US-380-4580/NCT03631732; GS-US-380-4030/NCT03110380 and GS-US-380-4449/NCT03405935), published in the JAIDS. Updated 22 Dec 2021 |
| 30 Oct 2021 | Results | Results presented at the 18th European AIDS Conference Updated 28 Dec 2021 |
| 03 Oct 2021 | Results | Results (n=1274) assessing the longer-term follow up on incidence of DM, hypertension (HTN), BMI categorical shifts, and lipid changes over 144 weeks of blinded treatment from two trials of PWH initiating antiretroviral therapy, presented at the IDWeek 2021. Updated 07 Feb 2022 |
| 20 Aug 2021 | Results | Results characterizing the efficacy and safety of B/F/TAF in FWH, including young, elderly, and ART-naive participants, data from 5 clinical trials ((NCT02652624, NCT02607930, NCT02607956, NCT02881320, NCT03405935) were analyzed published in the JAIDS Updated 16 Sep 2021 |
| 05 Aug 2021 | Biomarker Update | Biomarkers information updated Updated 06 Nov 2021 |
| 21 Jul 2021 | Results | Results assessing achievement of undetectable HIV-1 RNA through Week 144 from two clinical studies: GS-US380-1489 and GS-US380-1490 presented at the 11th International AIDS Society Conference on HIV Science Updated 03 Sep 2021 |
| 21 Jul 2021 | Results | Results assessing achievement of undetectable HIV-1 RNA through Week 144 from two clinical studies: GS-US380-1489 and GS-US380-1490 presented at the 11th International AIDS Society Conference on HIV Science Updated 01 Sep 2021 |
| 17 Jul 2021 | Results | Pooled data from open-label extension period of the study published in the Gilead Sciences Media Release. Updated 20 Jul 2021 |
| 17 Jul 2021 | Results | According to a Gilead Sciences media release, pooled data from open-label extension period of the study were presented at the 11th International AIDS Society (IAS) Conference on HIV Science. Updated 20 Jul 2021 |
| 15 Jul 2021 | Status change - completed | Status changed from active, no longer recruiting to completed. Updated 09 Aug 2021 |
| 12 Apr 2021 | Results | Results of three year resistance analysis and impact of baseline resistance substitutions on treatment response from two clinical studies: Study 1489 and Study 1490 published in the Journal of Antimicrobial Chemotherapy Updated 27 Apr 2021 |
| 10 Mar 2021 | Results | Results from Study 1490 and Study 1489 assessing effect of baseline transmitted drug resistance (TDR) on treatment response over 3 years presented at the 28th Conference on Retroviruses and Opportunistic Infections Updated 20 Apr 2021 |
| 10 Mar 2021 | Results | Results from Study 1490 and Study 1489; assessing 4 year safey and efficacy outcomes, presented at the 28th Conference on Retroviruses and Opportunistic Infections Updated 20 Apr 2021 |
| 06 Mar 2021 | Results | Results published in the Gilead Sciences Media Release. Updated 10 Mar 2021 |
| 06 Mar 2021 | Results | According to a Gilead Sciences media release, new, long-term data from open-label extension of the study and findings from a 144-week analysis were presented at the 28th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2021). Updated 10 Mar 2021 |
| 22 Dec 2020 | Completion date | Planned End Date changed from 1 May 2021 to 1 Jun 2021. Updated 13 Jan 2021 |
| 08 Oct 2020 | Results | Results of an analysis of bictegravir/emtricitabine/tenofovir alafenamide assessing efficacy against HIV-1 subtype F from five clinical studies: GS-US-380-1489, GS-US-380-1490, GS-US-380-1844, GS-US-380-1878 and GS-US-380-4449 presented at the 15th International Congress on Drug Therapy and HIV Infection Updated 11 Nov 2020 |
| 11 Mar 2020 | Results | Results (n=1274) of pooled analysis two randomized studies (study 1489 and 1490) assessing efficacy and safety (144-Week) of B/F/Taf in treatment-naive patients, of presented at the 27th Conference on Retroviruses and Opportunistic Infections. Updated 02 Apr 2020 |
| 11 Mar 2020 | Results | Results (n=1240) of two studies (study 1489 and 1490) assessing blip frequency and virologic outcomes of those experiencing blips in treatment-nave people with HIV, presented at the 27th Conference on Retroviruses and Opportunistic Infections. Updated 02 Apr 2020 |
| 09 Mar 2020 | Results | Results published in the Media Release Updated 17 Mar 2020 |
| 09 Nov 2019 | Results | Results of two phase 3 studies (Study 1489 & Study 1490 ) assessing Long-term efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide in HIV- infected patients presented at the 17th European AIDS Conference Updated 24 Jan 2020 |
| 09 Nov 2019 | Results | Results assessing efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide vs comparators in cis-women and girls from five studies including this study presented at the 17th European AIDS Conference. Updated 24 Jan 2020 |
| 06 Nov 2019 | Results | Results published in the Gilead Sciences Media Release. Updated 13 Nov 2019 |
| 06 Nov 2019 | Results | According to an Gilead Sciences media release, results from this study are being presented today at the 17th European AIDS Conference (EACS). Updated 13 Nov 2019 |
| 14 Oct 2019 | Results | Results of pooled analysis from 8 phase III trials (CTP 4999, 55400,55093,195806,228352,229699,263351 and 263352 )published in the Clinical Infectious Diseases Updated 22 Oct 2019 |
| 09 Aug 2019 | Other trial event | According to a Gilead Sciences media release, Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), has been approved in China for the treatment of HIV-1 infection, based on the results of 4 trials (1489, 1490, 1844 and 1878). Updated 13 Aug 2019 |
| 24 Jul 2019 | Results | Results assessing low-frequency resistance variants in ART-naive participants from studies 1489 and 1490 presented at the 10th International AIDS Society Conference on HIV Science Updated 03 Oct 2019 |
| 17 Jul 2019 | Completion date | Planned End Date changed from 1 Aug 2021 to 1 May 2021. Updated 01 Aug 2019 |
| 09 May 2019 | Completion date | Planned End Date changed from 1 Apr 2020 to 1 Aug 2021. Updated 23 May 2019 |
| 26 Mar 2019 | Other trial event | According to a Gilead Sciences media release, the Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. The approval of Biktarvy is supported by data from four Phase 3 studies (Studies 1489, 1490, 1844 and 1878). Updated 01 Apr 2019 |
| 07 Mar 2019 | Results | Results comparing the long-term safety and efficacy of B/F/TAF vs dolutegravir (DTG)-containing regimens in treatment-naive adults and the subset aged ≥50 y, in a pooled analysis from two phase 3 studies at Week 96, presented at the 26th Conference on Retroviruses and Opportunistic Infections Updated 03 May 2019 |
| 06 Mar 2019 | Results | Post-hoc analysis results using data from two phase 3 studies (Studies 1489 and 1490) evaluating Biktarvy in treatment-naive adults aged 50 and older (n=96/634), at Week 96 were presented in a Gilead Sciences media release. Updated 13 Mar 2019 |
| 25 Feb 2019 | Results | Results of the resistance analysis of Bictegravir/Emtricitabine/Tenofovir Alafenamide in HIV-1 Treatment-Naive Patients Through 48 Weeks in Studies 1489 and 1490, published in the Antimicrobial Agents and Chemotherapy Updated 01 Mar 2019 |
| 31 Oct 2018 | Results | Results of a pooled analysis of Study 1489 and Study 1490 assessing Bictegravir/emtricitabine/tenofovir-alafenamide in treatment-naive adults with high baseline viral load or low baseline CD4 count, presented at the 14th International Congress on Drug Therapy and HIV Infection Updated 27 Dec 2018 |
| 31 Oct 2018 | Results | Week-96 results presented at the 14th International Congress on Drug Therapy and HIV Infection Updated 24 Dec 2018 |
| 30 Oct 2018 | Other trial event | According to a Gilead Sciences media release, pooled analysis data from studies 1489 and 1490 with high viral loads (HIV-1 RNA > 100,000 c/mL) or low CD4 counts (CD4 < 200 cells/µL) are presented at the 2018 HIV Glasgow conference. Updated 12 Feb 2019 |
| 30 Oct 2018 | Results | According to Gilead Sciences media release, 96 week results from this study were presented at the 2018 HIV Glasgow conference in Glasgow Updated 12 Feb 2019 |
| 30 Oct 2018 | Results | Results (96 week ) presented in a Gilead Sciences media release. Updated 12 Feb 2019 |
| 03 Oct 2018 | Other trial event | According to Gilead Sciences media release,Based on the data from four phase III trials (Studies 1489, 1490, 1844 and 1878),that the Hong Kong Department of Health has approved Biktarvy,a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection in adults. Hong Kong is the first market in Asia to approve Biktarvy. Updated 09 Oct 2018 |
| 27 Jul 2018 | Results | Results of a pooled analysis of 1489 and 1490 studies assessing Bictegravir/emtricitabine/tenofovir-alafenamide in treatment-naive adults with high baseline viral load or low baseline CD4 count, presented at the 22nd International AIDS Conference Updated 30 Aug 2018 |
| 27 Jul 2018 | Results | Results of pooled data from five trials (GS-US-380-1489, GS-US-380-1490, GS-US-380-1844, GS-US-380-1878 and GS-US-380-1961 ) were presented at the 22nd International AIDS Conference. Updated 29 Aug 2018 |
| 25 Jun 2018 | Other trial event | According to a Gilead Sciences media release, the European Commission has granted Marketing Authorization for Biktarvy (bictegravir 50mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. The approval is based on four phase III trials (Studies 1489, 1490, 1844 and 1878). Updated 04 Jul 2018 |
| 03 May 2018 | Completion date | Planned End Date changed from 1 Apr 2019 to 1 Apr 2020. Updated 08 Jun 2018 |
| 27 Apr 2018 | Other trial event | The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the companys Marketing Authorization Application (MAA) for Biktarvy for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to the integrase class, emtricitabine or tenofovir. A European Commission decision is expected in mid-2018. Updated 03 May 2018 |
| 07 Mar 2018 | Results | Results of pooled efficacy analyses through week 48 and the effect of baseline resistance on treatment response of study 1489 and study 1490 presented at the 25th Conference on Retroviruses and Opportunistic Infections. Updated 24 Apr 2018 |
| 07 Mar 2018 | Results | Results from studies 1489, 1490, 1878 and 1844 presented at the 25th Conference on Retroviruses and Opportunistic Infections Updated 20 Apr 2018 |
| 08 Feb 2018 | Other trial event | According to a Gilead Sciences media release, Gilead plans to present data from this studies at scientific conferences in 2018. Updated 09 Feb 2018 |
| 08 Feb 2018 | Other trial event | According to a Gilead Sciences media release, based on the data from four phase III trials (Studies 1489, 1490, 1844 and 1878), the U.S. Food and Drug Administration (FDA) has approved Biktarvy, an investigational, once-daily single tablet regimen containing bictegravir (50 mg) (BIC), a novel investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) for the treatment of HIV-1 infection in adults. Updated 09 Feb 2018 |
| 31 Aug 2017 | Results | Results published in The Lancet. Updated 04 Sep 2017 |
| 10 Aug 2017 | Other trial event | According to a Gilead Sciences media release, the US FDA has granted priority review for the company's NDA for BIC/FTC/TAF, and the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of February 12, 2018. Updated 16 Aug 2017 |
| 26 Jul 2017 | Results | Results assessing 48-week efficacy and safety of the trial, presented at the 9th International AIDS Society Conference on HIV Science.. Updated 01 Sep 2017 |
| 24 Jul 2017 | Results | Results published in the Gilead Sciences Media Release Updated 27 Jul 2017 |
| 13 Jul 2017 | Other trial event | According to a Gilead Sciences media release, 48-week data from this and another phase 3 trial investigating BIC/FTC/TAF compared to regimens containing DTG in treatment-naive adult patients will be presented at the International AIDS Society Conference on HIV Science (IAS 2017). Updated 17 Jul 2017 |
| 13 Jul 2017 | Other trial event | The company's MAA for BIC/FTC/TAF has been fully validated and is now under evaluation by the European Medicines Agency (EMA), according to a Gilead Sciences media release. The MAA was supported by data from this and 3 other phase III trials. Updated 17 Jul 2017 |
| 12 Jun 2017 | Other trial event | According to a Gilead Sciences media release, the company plans to submit a marketing authorization application for BIC/FTC/TAF in the European Union in the third quarter of 2017. Updated 16 Jun 2017 |
| 12 Jun 2017 | Other trial event | According to a Gilead Sciences media release, based on the data from four phase III trials (Studies 1489, 1490, 1844 and 1878), the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily single tablet regimen containing bictegravir (50 mg) (BIC), a novel investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) for the treatment of HIV-1 infection in adults. Updated 16 Jun 2017 |
| 30 May 2017 | Other trial event | Gilead plans to submit data from this trial for presentations at scientific conferences in 2017, as reported in a media release. Updated 02 Jun 2017 |
| 30 May 2017 | Results | Results published in the Gilead Sciences Media Release Updated 02 Jun 2017 |
| 30 May 2017 | Other trial event | According to a Gilead Sciences media release, based on the data from this and other three Phase III trials (Studies 1489, 1490, 1844 and 1878) company is planning U.S. NDA Submission in Q2 2017 and EU MAA Filing in Q3 2017. Updated 02 Jun 2017 |
| 30 May 2017 | Endpoint met | Primary endpoint has been met. (Proportion of Participants who Achieve HIV-1 RNA 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm), as reported in a Gilead Sciences media release. Updated 02 Jun 2017 |
| 24 Nov 2016 | Completion date | Planned End Date changed from 1 May 2018 to 1 Apr 2019. Updated 29 May 2017 |
| 21 Jun 2016 | Status change - active, no longer recruiting | Status changed from recruiting to active, no longer recruiting. Updated 28 Jun 2016 |
| 05 May 2016 | Completion date | Planned End Date changed from 1 Jan 2019 to 1 May 2018. Updated 11 May 2016 |
| 28 Apr 2016 | Other trial event | New source identified and integrated (European Clinical Trials Database; EudraCT2015-003988-10). Updated 28 Apr 2016 |
| 13 Feb 2016 | Other trial event | New source identified and integrated (United Kingdom Clinical Research Network; 20692). Updated 13 Feb 2016 |
| 20 Nov 2015 | New trial record | New trial record Updated 20 Nov 2015 |
| 01 Apr 1994 | Results | Results published in the Pediatric Research Updated 17 Mar 2020 |
Table of Contents
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