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Studies 1489 & 1490: Post Hoc Pooled Analysis: Treatment-Naïve Adults Aged ≥50
Studies 1489 & 1490: Post Hoc Pooled Adherence Analysis
Studies 1489 & 1490: Post Hoc Pooled Analysis: High Baseline HIV-1 RNA and/or Low CD4 Count
Study 1489: Study Design
BIKTARVY vs ABC/DTG/3TC in treatment-naïve adults1-5
Phase 3, Randomized, Double-Blind, Active-Controlled, Noninferiority Study
Study Conducted: November 2015—July 20216
Primary endpoint
Proportion of adults with HIV-1 RNA <50 copies/mL at Week 48 (NI margin 12%) using the FDA snapshot algorithm5
Secondary endpoints
Efficacy, safety, and tolerability were assessed through Weeks 96 and 1443,4
Open-label extension
Efficacy in the OLE from Week 144 through Week 240 was calculated using missing=excluded (M=E) and missing=failure (M=F) analyses1,7
Study 14891,2
Retrospective Analysis of Preexisting Resistance at Baseline in Studies 1489 & 14903,*,†
BIKTARVY Arms From Studies 1489 & 1490 N‡=632 (IN) N‡=634 (PR/RT)
- Study participants with preexisting resistance substitutions causing reduced susceptibility to FTC, TAF, ABC, and 3TC were excluded at screening. Retrospective deep sequencing analysis was later attempted on baseline samples from all BIKTARVY-treated participants.
*This list is not inclusive of all RAMs observed in this analysis.3
†BIKTARVY is not indicated for patients with known or suspected substitutions associated with resistance to bictegravir or tenofovir.4
‡Retrospective deep sequencing data were combined with the population sequencing data from screening.
3TC, lamivudine; ABC, abacavir; CD4, cluster of differentiation 4; eGFRCG, estimated glomerular filtration rate (Cockcroft-Gault); FTC, emtricitabine, IN, integrase; INSTI, integrase strand transfer inhibitor; IQR, interquartile range; NNRTI, non-nucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; PR, protease; RAM, resistance-associated mutation; RT, reverse transcriptase; TAM, thymidine-associated mutation.
References: 1. Wohl DA, Yazdanpanah Y, Baumgarten A, et al. Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, Phase 3, non-inferiority trial. Lancet HIV. 2019;6(6):e355-e363. 2. Orkin C, DeJesus E, Sax PE, et al. Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, Phase 3, non-inferiority trials. Lancet HIV. 2020;7(6):e389-e400. 3. Acosta RK, Chen GQ, Chang S, et al. Three-year study of pre-existing drug resistance substitutions and efficacy of bictegravir/emtricitabine/tenofovir alafenamide in HIV-1 treatment-naïve participants. J Antimicrob Chemother. 2021;76(8):2153-2157. 4. BIKTARVY. Prescribing information. Gilead Sciences, Inc.; 2024.
Study 1489: Efficacy
5 years of durable viral suppression in treatment-naïve adults1-5
BIKTARVY was noninferior to ABC/DTG/3TC at Week 144
Virologic Response in Study 14892-5,8,*
*Percentages do not total 100% due to rounding.
†Treatment difference in HIV-1 RNA <50 copies/mL (95% confidence interval, P value).
Treatment outcomes were similar across subgroups, regardless of age, sex, race, baseline viral load, and baseline CD4+ cell count at Week 1442
Durable viral suppression at Week 2401
In a 96-week open-label extension from Week 144 through Week 240, virologic suppression at each study visit through Week 240 was assessed for adults who were initially randomized to BIKTARVY at Week 01,7:
- Using an M=E analysis, 97.7% (n=213) maintained virologic suppression at Week 240
- Using an M=F analysis, 66.2% (n=314) maintained virologic suppression at Week 240
Virologic suppression was also assessed in participants who switched from ABC/DTG/3TC to BIKTARVY at Week 1447:
- Using an M=E analysis, 99.5% (n=218) maintained virologic suppression at Week 240
- Using an M=F analysis, 85.4% (n=254) maintained virologic suppression at Week 240
In an M=E analysis, participants with missing data are excluded when calculating the proportion of participants with HIV-1 RNA <50 copies/mL. In an M=F analysis, all missing data are treated as treatment failures (HIV-1 RNA ≥50 copies/mL).
Overall rapid and sustained reduction in viral load with BIKTARVY1,3-5,7
Study 1489: Missing=Excluded (M=E) Analysis1,3-5,7
‡M=E data for participants who switched from ABC/DTG/3TC to BIKTARVY.
- In an M=E analysis, participants with missing data are excluded when calculating the proportion of participants with HIV-1 RNA <50 copies/mL
Study 1489: Missing=Failure (M=F) Analysis1,3-5,7
Data is presented from Study Week 0 to Week 240 for participants initially randomized to BIKTARVY. Data for participants who switched to BIKTARVY from ABC/DTG/3TC in the OLE is presented from OLE Week 0 to Week 96.
- Participants who switched from ABC/DTG/3TC had similar rates of virologic suppression (M=F) to participants initially started on BIKTARVY7
- In an M=F analysis, all missing data are treated as treatment failures (HIV-1 RNA ≥50 copies/mL)
Study 1489 Virologic Outcomes1-4,*
*Week 48 window was between Day 295 and 378 (inclusive); Week 96 window was between Day 631 and 714 (inclusive); Week 144 window was between Day 967 and 1050 (inclusive).
†Percentages do not total 100% due to rounding.
‡Includes participants who had ≥50 copies/mL in the Week 48, 96, or 144 window; participants who discontinued early due to lack or loss of efficacy; and participants who discontinued for reasons other than an adverse event (AE), death, or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥50 copies/mL.
§Includes participants who discontinued due to AE or death at any time point from Day 1 through the time window if this resulted in no virologic data on treatment during the specified window.
||Includes participants who discontinued for reasons other than an AE, death, or lack or loss of efficacy; eg, withdrew consent, loss to follow-up, etc.
CI, confidence interval.
References: 1. BIKTARVY. Prescribing information. Gilead Sciences, Inc.; 2024. 2. Gallant J, Lazzarin A, Mills A, et al. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, Phase 3, randomised controlled non-inferiority trial. Lancet. 2017;390(10107):2063-2072. 3. Wohl DA, Yazdanpanah Y, Baumgarten A, et al. Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, Phase 3, non-inferiority trial. Lancet HIV. 2019;6(6):e355-e363. 4. Orkin C, DeJesus E, Sax PE, et al. Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, Phase 3, non-inferiority trials. Lancet HIV. 2020;7(6):e389-e400.
IMPORTANT SAFETY INFORMATION
Adverse reactions
- Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%).
Study 1490: Study Design
BIKTARVY vs DTG+FTC/TAF in treatment-naïve adults1,2,4,9,10
Phase 3, Randomized, Double-Blind, Active-Controlled, Noninferiority Study
Study Conducted: November 2015—July 202111
Primary endpoint
Proportion of adults with HIV-1 RNA <50 copies/mL at Week 48 (NI margin 12%) using the FDA snapshot algorithm10
Secondary endpoints
Efficacy, safety, and tolerability were assessed through Weeks 96 and 1444,9
Open-label extension
Efficacy in the OLE from Week 144 through Week 240 was calculated using missing=excluded (M=E) and missing=failure (M=F) analyses1,7
Study 14901,2
Retrospective Analysis of Preexisting Resistance at Baseline in Studies 1489 & 14903,†,‡
BIKTARVY Arms From Studies 1489 & 1490 N§=632 (IN) N§=634 (PR/RT)
- Study participants with preexisting resistance substitutions causing reduced susceptibility to FTC, TAF, ABC, and 3TC were excluded at screening. Retrospective deep sequencing analysis was later attempted on baseline samples from all BIKTARVY-treated participants.
*Percentages do not total 100% due to rounding.
†This list is not inclusive of all RAMs observed in this analysis.3
‡BIKTARVY is not indicated for patients with known or suspected substitutions associated with resistance to bictegravir or tenofovir.4
§Retrospective deep sequencing data were combined with the population sequencing data from screening.
3TC, lamivudine; ABC, abacavir; CD4, cluster of differentiation 4; eGFRCG, estimated glomerular filtration rate (Cockcroft-Gault); FTC, emtricitabine; IN, integrase; INSTI, integrase strand transfer inhibitor; IQR, interquartile range; NNRTI, non-nucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; PI, protease inhibitor; PR, protease; RAM, resistance-associated mutation; RT, reverse transcriptase; TAM, thymidine-associated mutation.
References: 1. Stellbrink H-J, Arribas JR, Stephens JL, et al. Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, Phase 3, non-inferiority trial. Lancet HIV. 2019;6(6):e364-e372. 2. Orkin C, DeJesus E, Sax PE, et al. Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, Phase 3, non-inferiority trials. Lancet HIV. 2020;7(6):e389-e400. 3. Acosta RK, Chen GQ, Chang S, et al. Three-year study of pre-existing drug resistance substitutions and efficacy of bictegravir/emtricitabine/tenofovir alafenamide in HIV-1 treatment-naïve participants. J Antimicrob Chemother. 2021;76(8):2153-2157. 4. BIKTARVY. Prescribing Information. Gilead Sciences, Inc.; 2024.
Study 1490: Efficacy
5 years of durable viral suppression in treatment-naïve adults1,2,4,9,10
BIKTARVY was noninferior to DTG+FTC/TAF at Week 144
Virologic Response in Study 14902,4,8-10,*
*Percentages do not total 100% due to rounding.
†Treatment difference in HIV-1 RNA <50 copies/mL (95% confidence interval, P value).
Treatment outcomes were similar across subgroups, regardless of age, sex, race, baseline viral load, and baseline CD4+ cell count at Week 1442
Durable viral suppression at Week 2401
In a 96-week open-label extension from Week 144 through Week 240, virologic suppression at each study visit through Week 240 was assessed for adults who were initially randomized to BIKTARVY at Week 01,7:
- Using an M=E analysis, 99.5% (n=219) maintained virologic suppression at Week 240
- Using an M=F analysis, 68.1% (n=320) maintained virologic suppression at Week 240
Virologic suppression was also assessed in participants who switched from DTG+FTC/TAF to BIKTARVY at Week 1447:
- Using an M=E analysis, 99.1% (n=234) maintained virologic suppression at Week 240
- Using an M=F analysis, 87.5% (n=265) maintained virologic suppression at Week 240
In an M=E analysis, participants with missing data are excluded when calculating the proportion of participants with HIV-1 RNA <50 copies/mL. In an M=F analysis, all missing data are treated as treatment failures (HIV-1 RNA ≥50 copies/mL).
Overall rapid and sustained reduction in viral load with BIKTARVY1,4,7,9,10
Study 1490: Missing=Excluded (M=E) Analysis1,4,7,9,10
§M=E data for participants who switched from DTG+FTC/TAF to B/F/TAF.
- In an M=E analysis, participants with missing data are excluded when calculating the proportion of participants with HIV-1 RNA <50 copies/mL
Study 1490: Missing=Failure (M=F) Analysis1,4,7,9,10
Data is presented from Study Week 0 to Week 240 for participants initially randomized to BIKTARVY. Data for participants who switched to BIKTARVY from DTG+FTC/TAF in the OLE is presented from OLE Week 0 to Week 96.
- Participants who switched from DTG+FTC/TAF regimens had similar rates of virologic suppression (M=F) to participants initially started on BIKTARVY7
- In an M=F analysis, all missing data are treated as treatment failures (HIV-1 RNA ≥50 copies/mL)
Study 1490 Virologic Outcomes1-4,*
*Week 48 window was between Day 295 and 378 (inclusive); Week 96 window was between Day 631 and 714 (inclusive); Week 144 window was between Day 967 and 1050 (inclusive).
†Includes participants who had ≥50 copies/mL in the Week 48, 96, or 144 window; participants who discontinued early due to lack or loss of efficacy; and participants who discontinued for reasons other than an adverse event (AE), death, or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥50 copies/mL.
‡Includes participants who discontinued due to AE or death at any time point from Day 1 through the time window if this resulted in no virologic data on treatment during the specified window.
§Includes participants who discontinued for reasons other than an AE, death, or lack or loss of efficacy; eg, withdrew consent, loss to follow-up, etc.
CI, confidence interval.
References: 1. BIKTARVY. Prescribing information. Gilead Sciences, Inc.; 2024. 2. Sax PE, Pozniak A, Montes ML, et al. 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. Lancet. 2017;390(10107):2073-2082. 3. Stellbrink H-J, Arribas JR, Stephens JL, et al. Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, Phase 3, non-inferiority trial. Lancet HIV. 2019;6(6):e364-e372. 4. Orkin C, DeJesus E, Sax PE, et al. Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, Phase 3, non-inferiority trials. Lancet HIV. 2020;7(6):e389-e400.
IMPORTANT SAFETY INFORMATION
Adverse reactions
- Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%).
Studies 1489 & 1490: Similar results between BIKTARVY and comparators in treatment-naïve participants aged ≥50 and <50 years at Week 14412
Post Hoc Subgroup Analysis of Pooled Data at Week 144
- Efficacy was similar in treatment-naïve study participants in both the ≥50 and <50 years of age group12
- 20% of adults aged ≥50 years in the BIKTARVY study arm (n=96) had a baseline CD4 count <200 cells/μL12
*BIKTARVY vs ABC/DTG/3TC, P=0.73; BIKTARVY vs DTG + FTC/TAF, P=0.24.
†BIKTARVY vs ABC/DTG/3TC, P=0.34; BIKTARVY vs DTG + FTC/TAF, P=0.80.
Studies 1489 & 1490: Post Hoc Pooled Adherence Analysis
Methods
- A retrospective post hoc pooled analysis of Studies 1489 and 1490 data in treatment-naïve adults8,13
- Study participants were categorized based on their adherence through Weeks 48, 96, and 1448,13
- Study participants in the clinical studies were instructed to take one tablet of BIKTARVY once daily, which is recommended in the full Prescribing Information2,4,5,10
Outcomes
- Treatment adherence through Weeks 48, 96, and 1448,13
- Virologic response on BIKTARVY treatment (using M=E analysis) at Weeks 48, 96, and 144 in participants initially randomized to BIKTARVY8,13
- – The adherence data analysis used an on-treatment M=E analysis that only included patient data collected during BIKTARVY treatment. This varies from other M=E analyses that include all patient data regardless of whether patients discontinued BIKTARVY.
Adherence Calculation8,13
- Adherence was categorized as high (≥95%), intermediate (≥85% to <95%), or low (<85%)
- Adherence was calculated by counting the number of pills remaining based on returned pill bottles and only included participants with ≥1 returned pill bottle13
Limitations
- This analysis was not prespecified and statistical testing for comparison was not conducted
- Data should be considered descriptive only, and efficacy conclusions based on adherence categories should not be drawn
- Adherence may be higher in a clinical trial setting compared to real-world experiences for reasons that include regular study visits and being asked to return pill bottles
BIKTARVY Study Participant Adherence Information
Adherence Categories for Study Participants Initially Randomized to BIKTARVY8
Continue to counsel your patients to take BIKTARVY every day as prescribed.2
This analysis was not prespecified and statistical testing for comparison was not conducted. Data should be considered descriptive only.
Adherence calculation was based on returned pill bottle pill count and only included participants with ≥1 returned pill bottle.
Adherence may be higher in a clinical trial setting compared to real-world experiences for reasons that include regular study visits and being asked to return pill bottles.
Total Participants Initially Randomized to BIKTARVY (N=624)8
Adherence Category
Week 48 Excluded From M=E Analysis (Missing Virologic Data)
(n=43)
Week 48 Included in M=E Analysis (n=581)
Week 96 Excluded From M=E Analysis (Missing Virologic Data)
(n=78)
Week 96 Included in M=E Analysis (n=546)
Week 144 Excluded From M=E Analysis (Missing Virologic Data)
(n=104)
Week 144 Included in M=E Analysis (n=520)
High adherence (≥95%)
18
458
35
408
49
388
Intermediate adherence (≥85% to <95%)
15
100
26
117
36
113
Low adherence (<85%)*
10
23
17
21
19
19
Total Participants Initially Randomized to BIKTARVY at Week 48 (N=624)8
Adherence Category
Week 48 Excluded From M=E Analysis (Missing Virologic Data)
(n=43)
Week 48 Included in M=E Analysis (n=581)
High adherence (≥95%)
18
458
Intermediate adherence (≥85% to <95%)
15
100
Low adherence (<85%)*
10
23
*Median (IQR) adherence for the low adherence category through Week 48 (n=33) was 78.3% (76.5%, 82.0%). Median adherence was calculated for all participants, including those with missing virologic data.
Virologic Suppression Rates by Adherence Category at Week 48 Using M=E Analysis8
In an M=E analysis, study participants with missing data are excluded when evaluating virologic suppression.
Continue to counsel your patients to take BIKTARVY every day as prescribed.2
This analysis was not prespecified and statistical testing for comparison was not conducted. Data should be considered descriptive only, and efficacy conclusions based on adherence categories should not be drawn.
Participants in the clinical studies were instructed to take the study drug once daily.2,4,5,10
Total Participants Initially Randomized to BIKTARVY at Week 96 (N=624)8
Adherence Category
Week 96 Excluded From M=E Analysis (Missing Virologic Data)
(n=78)
Week 96 Included in M=E Analysis (n=546)
High adherence (≥95%)
35
408
Intermediate adherence (≥85% to <95%)
26
117
Low adherence (<85%)†
17
21
†Median (IQR) adherence for the low adherence category through Week 96 (n=38) was 80.0% (77.0%, 82.7%). Median adherence was calculated for all participants, including those with missing virologic data.
Virologic Suppression Rates by Adherence Category at Week 96 Using M=E Analysis8
In an M=E analysis, study participants with missing data are excluded when evaluating virologic suppression.
Continue to counsel your patients to take BIKTARVY every day as prescribed.2
This analysis was not prespecified and statistical testing for comparison was not conducted. Data should be considered descriptive only, and efficacy conclusions based on adherence categories should not be drawn.
Participants in the clinical studies were instructed to take the study drug once daily.2,4,5,10
Total Participants Initially Randomized to BIKTARVY at Week 144 (N=624)8
Adherence Category
Week 144 Excluded From M=E Analysis (Missing Virologic Data)
(n=104)
Week 144 Included in M=E Analysis (n=520)
High adherence (≥95%)
49
388
Intermediate adherence (≥85% to <95%)
36
113
Low adherence (<85%)‡
19
19
‡Median (IQR) adherence for the low adherence category through Week 144 (n=38) was 79.6% (77.0%, 81.8%). Median adherence was calculated for all participants, including those with missing virologic data.
Virologic Suppression Rates by Adherence Category at Week 144 Using M=E Analysis8
In an M=E analysis, study participants with missing data are excluded when evaluating virologic suppression.
Continue to counsel your patients to take BIKTARVY every day as prescribed.2
This analysis was not prespecified and statistical testing for comparison was not conducted. Data should be considered descriptive only, and efficacy conclusions based on adherence categories should not be drawn.
Participants in the clinical studies were instructed to take the study drug once daily.2,4,5,10
*Median (IQR) adherence for the low adherence category through Week 48 (n=33) was 78.3% (76.5%, 82.0%), through Week 96 (n=38) was 80.0% (77.0%, 82.7%), through Week 144 (n=38) was 79.6% (77.0%, 81.8%). Median adherence was calculated for all participants, including those with missing virologic data.
Continue to counsel your patients to take BIKTARVY every day as prescribed.2
This analysis was not prespecified and statistical testing for comparison was not conducted. Data should be considered descriptive only, and efficacy conclusions based on adherence categories should not be drawn.
Participants in the clinical studies were instructed to take the study drug once daily.2,4,5,10
Virologic Suppression Rates by Adherence Category Using M=E Analysis8
In an M=E analysis, study participants with missing data are excluded when evaluating virologic suppression.
Continue to counsel your patients to take BIKTARVY every day as prescribed.2
This analysis was not prespecified and statistical testing for comparison was not conducted. Data should be considered descriptive only, and efficacy conclusions based on adherence categories should not be drawn.
Participants in the clinical studies were instructed to take the study drug once daily.2,4,5,10
IMPORTANT SAFETY INFORMATION
Adverse reactions
- Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%).
Studies 1489 and 1490: Post Hoc Pooled Analysis
5 years of viral suppression in treatment-naïve adults with high baseline viral load and low CD4 cell count2,5,10,14
In a post hoc subgroup analysis of pooled data from Studies 1489 and 1490 through Week 240, participants initially randomized to BIKTARVY were stratified by:
- Baseline viral load (BL VL) <100,000, 100,000 to 400,000, and >400,000 copies/mL
- Baseline CD4 < or ≥200 cells/μL
- Baseline viral load ≥100,000 copies/mL and CD4 <200 cells/μL
Post Hoc Pooled Analysis of Studies 1489 and 1490 Using an M=E Analysis14
- In an M=E analysis, participants with missing data are excluded when calculating the proportion of participants with HIV-1 RNA <50 copies/mL.
Virologic suppression was achieved and maintained in all subgroups at 5 years14
Post Hoc Pooled Analysis of Studies 1489 and 1490 Using an M=F Analysis14
Treatment-Naïve Adults with HIV-1 RNA <50 copies/mL, %
- In an M=F analysis, all missing data are treated as treatment failures (HIV-1 RNA ≥50 copies/mL).
Studies 1489 and 1490: Resistance
Zero cases of resistance to BIKTARVY through 5 years in treatment-naïve adults1,2,7
Among the treatment-naïve adults who participated in Studies 1489 and 1490, 634 participants received BIKTARVY through Week 144 of the double-blind phase, and 1025 participants received BIKTARVY through Week 96 of the extension phase. Of the 1025 treatment-naïve adults who participated in the OLE, 506 participants continued on BIKTARVY, 254 participants switched from ABC/DTG/3TC, and 265 participants switched from DTG+FTC/TAF at Week 144.1,2,7
In the final resistance analysis population, no amino acid substitutions associated with BIKTARVY resistance emerged in the 11 participants who experienced treatment failure and had evaluable genotypic resistance data.2
3TC, lamivudine; ABC, abacavir; AE, adverse event; CD4, cluster of differentiation 4; DTG, dolutegravir; eGFRCG, estimated glomerular filtration rate (Cockcroft-Gault); FDA, US Food and Drug Administration; FTC, emtricitabine; HBV, hepatitis B virus; HCV, hepatitis C virus; INSTI, integrase strand transfer inhibitor; IQR, interquartile range; M=E, missing=excluded; M=F, missing=failure; NI, noninferiority; NNRTI, non-nucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; OLE, open-label extension; QD, once daily; RNA, ribonucleic acid; TAF, tenofovir alafenamide. TDF, tenofovir disoproxil fumarate.
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