Biktarvy® (BIC/FTC/TAF)

Use in Baseline NRTI Resistance

This document is in response to your request for information regarding the use of Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide [BIC/FTC/TAF]) in patients with baseline (BL) nucleos(t)ide reverse transcriptase inhibitor resistance (NRTI-R).

Some data may be outside of the US FDA-approved prescribing information. In providing this data, Gilead Sciences, Inc. is not making any representation as to its clinical relevance or to the use of any Gilead product(s). For information about the approved conditions of use of any Gilead drug product, please consult the FDA-approved prescribing information.

The full indication, important safety information, and boxed warnings are available at:
www.gilead.com/-/media/files/pdfs/medicines/hiv/biktarvy/biktarvy_pi.

Summary

Product Labeling1

BIC/FTC/TAF is indicated as a complete regimen for the treatment of HIV‑1 in adults and pediatric patients weighing ≥14 kg who have no ARV treatment history, or with an ARV treatment history and not virologically suppressed, with no known or suspected substitutions associated with resistance to the INSTI class, FTC, or TFV, or to replace the current ARV regimen in those who are VS (HIV‑1 RNA <50 c/mL) on a stable ARV regimen with no known or suspected substitutions associated with resistance to BIC or TFV.

Clinical Studies: Use of BIC/FTC/TAF in BL NRTI-R

Across multiple clinical studies and at various timepoints, ARV-naive and TE PWH with BL NRTI-R achieved or maintained high rates (90–100%) of virologic suppression on BIC/FTC/TAF.2-15

Real-World Data: Use of BIC/FTC/TAF in BL NRTI-R

In real-world studies of BIC/FTC/TAF treatment in ARV-naive and TE PWH with BL NRTI-R, high rates (87.5–100%) of virologic suppression were observed at various timepoints.16-24

Clinical Studies: Use of BIC/FTC/TAF in BL NRTI-R

Pooled Prevalence: M184V/I Resistance in VS Participants2

Study design and BL resistance

A pooled analysis was conducted in participants (N=2034) from Studies 4030, 4580 (BRAAVE 2020), 1844, 1878, 4449, and 1474 to evaluate the prevalence of preexisting M184V/I resistance mutation and its effect on virologic outcomes in VS (ie, HIV‑1 RNA <50 c/mL for 3 or 6 months) participants who switched to BIC/FTC/TAF. In Studies 4030 and 4580, participants with BL M184V/I mutations were allowed, but other studies included in the analysis excluded participants if an M184V/I mutation was detected prior to the switch in therapy. Historical genotype reports were collected during enrollment, if available, and HIV-1 proviral DNA genotype testing was conducted retrospectively on any available BL samples.

Most M184V/I mutations were identified by BL proviral DNA genotyping (167/182; 92%). Eighty-one percent of participants with M184V/I mutations (147/182) had ≥1 other resistance substitution.

Table 1. Pooled Analysis: Frequency of BL NRTI-R Substitutions in Participants Treated With BIC/FTC/TAF (Sax et al)2

Efficacy results

High rates (97–100% based on missing=excluded analyses) of virologic suppression (HIV‑1 RNA <50 c/mL) were maintained up to 180 weeks after switching to BIC/FTC/TAF, and no treatment-emergent resistance was detected. In participants with preexisting M184V/I who received BIC/FTC/TAF (median duration, 69 weeks), rates of virologic suppression were high (Figure 1). Rates of virologic suppression were similar between participants with and without M184V/I resistance mutations (98% vs 99%, respectively; P=0.48).

Figure 1. Pooled Analysis: Virologic Suppression by Preexisting M184V/I in the
BIC/FTC/TAF Group (LOCF; Sax et al)2

Abbreviation: WT=wild-type allele.

Safety outcomes were not provided for this pooled analysis. Please see product labeling for BIC/FTC/TAF safety information.

Pooled Prevalence: Preexisting TAMs and Outcomes3

Study design and BL resistance

A pooled analysis was conducted in PWH (N=2286) from Studies 4030, 4580, 1844, 1878, and 4449 to evaluate the prevalence of preexisting TAMs and their effect on virologic outcomes after participants switched to BIC/FTC/TAF. Historical genotype reports were collected after enrollment, if available, and HIV-1 proviral DNA genotype testing was conducted on BL samples; participants with previously undetected BL resistance mutations were allowed to remain in the study and were included in all analyses.

In the pooled analysis, 91% of participants who received BIC/FTC/TAF had PR/RT data available, and preexisting TAMs were detected in 10% of these participants (Table 2).

Table 2. Pooled Analysis: BL Resistance Data in Participants Treated With BIC/FTC/TAF (Andreatta et al)3

aTAMs: K70R, 5%; M41L, 4%; D67N, 4%; K219E/N/Q/R, 4%; T215F/Y, 4%; L210W, 2%.

Efficacy results

High rates of virologic suppression (using LOCF imputation) were maintained after participants switched to BIC/FTC/TAF for a median treatment duration of 72 weeks, and no treatment-emergent resistance was detected (Figure 2).

Figure 2. Pooled Analysis: Virologic Suppression at Last Study Visit by
Preexisting TAMs (LOCF; Andreatta et al)3

aNo participants with ≥1 TAM and primary INSTI-R received BIC/FTC/TAF.

Note: The median treatment durations of BIC/FTC/TAF are presented in each bar.

Safety outcomes were not provided for this pooled analysis. Please see product labeling for BIC/FTC/TAF safety information.

Studies 1489 and 1490: BL Resistance in ARV-Naive PWH

Study design and BL resistance

An integrated viral resistance analysis of two phase 3 clinical trials in ARV‑naive PWH comparing BIC/FTC/TAF to DTG/ABC/3TC (Study 1489) or DTG + FTC/TAF (Study 1490) was conducted. All participants were screened using HIV-1 genotypic data with PR and RT population sequencing data obtained from the GenoSure MG assay.4,5 Exclusion criteria included resistance to study drugs. BL NRTI resistance-associated substitutions (1–2 TAMs [n=19], K219E/N/Q/R [n=11], M41L [n=4], D67N [n=3], K70R [n=3], K65E/R detected by retrospective deep sequencing [n=2], L74V [n=1]) were identified in 3% of participants in the BIC/FTC/TAF arms (n=634).4

Efficacy results

BIC/FTC/TAF demonstrated noninferior efficacy (HIV-1 RNA <50 c/mL) to DTG/ABC/3TC (Study 1489) and DTG + FTC/TAF (Study 1490) by FDA Snapshot analysis at Week 144.6 Preexisting NRTI‑R using a mutation frequency cutoff of ≥15% was discovered in 21 participants who received BIC/FTC/TAF, 8 participants who received DTG/ABC/3TC, and 6 participants who received DTG + FTC/TAF; 100% of these participants were VS at Week 144.4

Primary NRTI-R mutations were detected at low frequencies (2–15%) using retrospective deep sequencing in an additional 3.7% of ARV‑naive participants (47/1270). Using the LOCF method, high rates of virologic suppression (100%) were observed in participants with BL primary NRTI-R, including low-frequency M184V or K65R resistance substitutions, at Week 96 across all treatment arms.5

Safety results at Week 1446

A safety analysis was not conducted in the subgroup of participants with BL NRTI-R. Overall, the most common all-grade adverse reactions reported in ≥10% of all participants in the BIC/FTC/TAF arms in either study through Week 144 were nausea, diarrhea, URTI, headache, nasopharyngitis, back pain, fatigue, cough, and syphilis. AEs led to study drug discontinuation in no participants in the BIC/FTC/TAF arm in Study 1489 and in 6 participants (2%) in the BIC/FTC/TAF arm in Study 1490.

Studies 1878 and 1844: BL Resistance in VS PWH

Study design7

An integrated viral resistance analysis of two phase 3 clinical trials in VS PWH comparing BIC/FTC/TAF to PI + 2 NRTIs (Study 1878) or DTG/ABC/3TC (Study 1844) was conducted. Exclusion criteria included documented or suspected resistance to FTC, TFV, DTG, ABC, or 3TC, including, but not limited to, K65R and M184V/I in RT. The resistance analysis population consisted of participants with confirmed VF with HIV‑1 RNA ≥200 c/mL at the confirmation visit or HIV‑1 RNA ≥200 c/mL at Week 48 or last visit on study drug; plasma viral RNA genotyping and phenotyping of PR, RT, and integrase were attempted for all participants in this population.

Efficacy results at Week 487

Switching to BIC/FTC/TAF demonstrated noninferior efficacy (HIV-1 RNA <50 c/mL) by FDA Snapshot analysis compared with staying on PI + 2 NRTIs or DTG/ABC/3TC at Week 48. Among participants in the BIC/FTC/TAF arms with available BL NRTI genotypic data (n=405), 13% had primary NRTI-R substitutions (K65N/R [n=5], M184I/V [n=30], L74V [n=2], Y115F [n=2], Q151M [n=2]). At Week 48, among participants who switched to BIC/FTC/TAF, 94% of participants (49/52) with BL NRTI-R and 90% (27/30) with BL M184I/V maintained virologic suppression. No treatment-emergent resistance was detected among participants in the BIC/FTC/TAF arm.

Open-label extension phase

In Study 1878, 94/98 participants with BL NRTI-R and 59/62 participants with BL M184V/I who received BIC/FTC/TAF for a median duration of 101 weeks had HIV‑1 RNA <50 c/mL at their last visit.8 In Study 1844, 47/48 participants with BL NRTI-R and 17/17 participants with BL M184V/I who received BIC/FTC/TAF for a median duration of 96 weeks had HIV‑1 RNA <50 c/mL at their last visit.9

Safety results

A safety analysis was not conducted in the subgroup of participants with BL NRTI-R. In Study 1878, the most common adverse reactions (all grades) reported in ≥10% of all participants who received ≥1 dose of BIC/FTC/TAF through a median exposure of 101 weeks were headache, nasopharyngitis, URTI, and diarrhea.8 In Study 1844, the most common adverse reactions (all grades) reported in ≥10% of all participants who received ≥1 dose of BIC/FTC/TAF through a median exposure of 96 weeks were URTI, nasopharyngitis, and diarrhea.9

Study 4030: BL Resistance in VS PWH

Study design10

A phase 3, randomized, double-blind, multicenter, active-controlled study evaluated the efficacy of BIC/FTC/TAF (n=284) vs DTG + FTC/TAF (n=281) in VS PWH, including those with known BL resistance mutations. Eligible participants were those currently receiving treatment with DTG + FTC/TAF or DTG + FTC/TDF, with HIV-1 RNA <50 c/mL for ≥3 months if NRTI-R was not known or suspected or ≥6 months if NRTI-R was known or suspected, and with no documented INSTI-R or confirmed VF during treatment with an INSTI-containing regimen. Known or suspected resistance to NRTIs, PIs, and/or NNRTIs was permitted. The primary endpoint was the proportion of participants with plasma HIV‑1 RNA ≥50 c/mL at Week 48 by FDA Snapshot analysis, with a prespecified noninferiority margin of 4%. Participants were randomly assigned in a 1:1 ratio to switch to BIC/FTC/TAF or DTG + FTC/TAF; randomization was stratified by NRTI-R category based on historical genotype.

Efficacy results at Week 48

Switching to BIC/FTC/TAF demonstrated noninferior efficacy (HIV-1 RNA ≥50 c/mL) by FDA Snapshot analysis vs staying on DTG + FTC/TAF at Week 48.10 Rates of virologic suppression were high regardless of preexisting NRTI-R (Table 3). No participant with known or suspected BL NRTI-R in either treatment arm had HIV-1 RNA ≥50 c/mL at Week 48 or their last visit, including 81 participants (BIC/FTC/TAF, n=47; DTG + FTC/TAF, n=34) with BL M184V/I resistance mutations. No treatment-emergent resistance was observed in either arm through Week 48.11

Table 3. Study 4030: BL Resistance and Virologic Outcomes at Week 48 by
FDA Snapshot Analysis10,11

aTwenty participants were stratified to Categories 1 or 2 based on investigator-suspected NRTI-R that was not confirmed by genotyping.

bResistance Category 1: K65R/E/N, ≥3 TAMs, including M41L or L210W, or T69 insertions.

cResistance Category 2: M184V/I, K70E/G/M/Q/S/T, L74V/I, V75A/S/M/T, Y115F, T69D, Q151M, M41L, D67N, K70R, L210W, T215F/Y, or K219Q/E/R/N.

dResistance Category 3: no NRTI RAMs.

Safety results at Week 4810

A safety analysis was not conducted in the subgroup of participants with BL NRTI-R. The most commonly reported AEs (≥10%) in either group were nasopharyngitis, diarrhea, and URTI. Drug-related AEs that occurred in ≥2% in either group were diarrhea and headache. Six participants (2%) in each arm discontinued the study because of AEs.

BRAAVE 2020 Study

Study design and BL resistance12

A phase 3, randomized, open‑label, active-controlled study evaluated the safety and efficacy of switching to BIC/FTC/TAF (n=330) or continuing a BL regimen of 2 NRTIs plus a third agent (n=165) in VS PWH who were located in the USA and self-identified as Black or African American. Exclusion criteria consisted of primary INSTI-R or NRTI-R (K65R/E/N, T69 insertions, or ≥3 TAMs). Resistance to PIs, NNRTIs, and NRTIs (M184V/I, 1–2 TAMs, and other substitutions) was permitted. Participants were randomly assigned in a 2:1 ratio to stay on BL regimen or switch to BIC/FTC/TAF until Week 24, at which point participants randomly assigned to stay on BL regimen were switched to BIC/FTC/TAF until Week 48. After Week 48, all participants were given the option to participate in the extension phase, in which they received BIC/FTC/TAF for an additional 24 weeks. BL resistance was analyzed using historical genotypes and retrospective HIV-1 proviral DNA genotype testing of BL samples. Preexisting BL NRTI mutations were detected in 15% of participants (Table 4).

Table 4. BRAAVE 2020: Proportion of Participants With Preexisting
NRTI-R Substitutions12

Efficacy results through Week 7212

Switching to BIC/FTC/TAF was noninferior to continuing the BL regimen at Week 24. High rates of virologic suppression (98–100%) were maintained through Week 72 on BIC/FTC/TAF, regardless of preexisting NRTI-R, including M184V/I or ≥1 TAM (Figure 3). All participants with preexisting NRTI‑R had virologic suppression at their last study visit. No treatment‑emergent resistance was observed.

Figure 3. BRAAVE 2020: Virologic Outcomes at Last Visit Through Week 7212

Safety results

A safety analysis was not conducted in the subgroup of participants with BL NRTI-R. Switching to BIC/FTC/TAF was well tolerated, and reported AEs were comparable between the two treatment arms at Week 24.13 All-grade AEs that occurred in ≥5% of participants who received BIC/FTC/TAF at any time (n=493) included URTI, syphilis, headache, pain in extremity, arthralgia, hypertension, and nasopharyngitis.14

PIBIK: Phase 4 Study of BIC/FTC/TAF vs Boosted PI15

Study design and BL resistance

A phase 4, randomized, multicenter, open-label pilot study evaluated the efficacy and safety of switching to BIC/FTC/TAF immediately (n=33) or continuing a boosted PI with a delayed switch to BIC/FTC/TAF (n=39) after 24 weeks in VS PWH with BL NRTI-R. Eligible participants had HIV-1 RNA <50 c/mL for ≥6 months and had historical genotypes that showed no existing INSTI mutations and the presence of M184V/I alone or with other NRTI‑associated mutations and/or ≤2 TAMs with or without M184V/I. The primary endpoint was the pure virologic response rate (HIV-1 RNA <50 c/mL) at Week 24. Secondary endpoints included a comparison of pure virologic responses after 48 weeks of BIC/FTC/TAF in the immediate switch group vs 24 weeks of BIC/FTC/TAF in the delayed switch group.

Table 5. PIBIK: BL Drug Resistance Mutations (Historical Genotypes)15

Abbreviation: NAM=NRTI-associated mutation.

aNAM mutations could include the following: L74I/V, Y115F, and K70E/G/Q/T/N/S. TAM mutations could include the following: M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R.

Efficacy results up to Week 48

At both Week 24 and Week 48, the pure virologic response rates were 100% in the immediate switch group and 97.4% (38/39) in the delayed switch group (difference between arms, 2.6%; 95% CI: ‑2.4% to 7.5%).

Safety results up to Week 48

From BL to Week 24, the most common AEs (≥10%) in the immediate switch group were headaches and hypertension (each 12%), and no AE was experienced by ≥10% of the delayed switch group. One participant in each group discontinued due to AEs. From Week 24 to Week 48, no AEs in the immediate switch group and headaches (10.3%) in the delayed switch group were experienced by ≥10% of participants. From Week 24 to Week 48, no participants in the immediate switch group and 3 participants in the delayed switch group discontinued due to AEs.

Real-World Data: Use of BIC/FTC/TAF in BL NRTI-R

Key real-world studies are presented in Table 6. Data may not be all-inclusive.

Table 6. Summary of Real-World Studies16-24

Abbreviations: BICSTaR=BIC single-tablet regimen; PP=per protocol.

aAll patients were VS at baseline.

bSafety analyses were not conducted in the subgroup of patients with BL NRTI-R.

cRepresents the percentage of patients who maintained HIV‑1 RNA <200 c/mL.

References

1. Enclosed, Gilead Sciences Inc. BIKTARVY® (bictegravir, emtricitabine, and tenofovir alafenamide) tablets, for oral use. US Prescribing Information. Foster City, CA.
2. Sax PE, Andreatta K, Molina JM, et al. High efficacy of switching to bictegravir/emtricitabine/tenofovir alafenamide in people with suppressed HIV and preexisting M184V/I. AIDS. 2022;36(11):1511-1520. https://www.ncbi.nlm.nih.gov/pubmed/35466963
3. Andreatta K, Acosta R, D'Antoni ML, et al. Prevalence and Risk Factors of Preexisting TAMs in Clinical Trial Participants and Sustained Viral Suppression After Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) [Poster PE1/6]. Paper presented at: 18th European AIDS Conference; October 27-30, 2021; London, United Kingdom.
4. 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-naive participants. J Antimicrob Chemother. 2021.
5. Acosta R, Willkom M, Martin R, et al. Low-Frequency Resistance Variants in ART-Naive Participants Do Not Affect Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) Triple Therapy Outcome [Poster MOPEB242]. Paper presented at: 10th IAS Conference on HIV Science (IAS 2019); 21-24 July, 2019; Mexico City, Mexico.
6. Orkin C, DeJesus E, Sax PE, et al. Three-Year Outcomes of the Fixed-Dose Combination Bictegravir, Emtricitabine, and Tenofovir Alafenamide vs Dolutegravir-Containing Regimens for Initial Treatment of HIV-1 Infection: Week 144 Results from Two Randomised, Double-Blind, Multicentre, Phase 3, Non-Inferiority Trials. The Lancet HIV. 2020;7:e389–400.
7. Andreatta K, Willkom M, Martin R, et al. Resistance Analyses of Bictegravir/Emtricitabine/Tenofovir Alafenamide Switch Studies [Poster 506]. Paper presented at: Conference on Retroviruses and Opportunistic Infections (CROI); 04-07 March, 2018; Boston, MA.
8. Rockstroh JK, Molina JM, Post F, et al. Long-Term Follow-Up After a Switch to Bictegravir, Emtricitabine, Tenofovir Alafenamide (B/F/TAF) from a Boosted Protease Inhibitor-Based Regimen [Poster P036]. Paper presented at: HIV GLASGOW Drug Therapy Virtual; 05-08 October, 2020; Glasgow, UK.
9. Brar I, Ruane P, Ward D, et al. Long-term Follow-up After a Switch to Bictegravir, Emtricitabine, and Tenofovir Alafenamide From Dolutegravir, Abacavir, and Lamivudine [Poster 1028]. Paper presented at: IDWeek Virtual; 21-25 October, 2020.
10. Sax PE, Rockstroh JK, Luetkemeyer AF, et al. Switching to bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults with Human Immunodeficiency Virus. Clin Infect Dis. 2020:1-9.
11. Acosta RK, Willkom M, Andreatta K, et al. Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) from Dolutegravir (DTG)+F/TAF or DTG+F/Tenofovir Disoproxil Fumarate (TDF) in the Presence of Pre-Existing NRTI Resistance. J Acquir Immune Defic Syndr. 2020;85(3):363-371. https://www.ncbi.nlm.nih.gov/pubmed/32701823
12. Andreatta K, D'Antoni ML, Chang S, et al. High efficacy of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in Black adults in the United States, including those with pre-existing HIV resistance and suboptimal adherence. J Med Virol. 2024;96(10):e29899.
13. Hagins D, Kumar P, Saag M, et al. Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Black Americans With HIV-1: A Randomized Phase 3b, Multicenter, Open-Label Study. J Acquir Immune Defic Syndr. 2021;88(1):86-95.
14. Kumar P, Stephens JL, Wurapa AK, et al. Week 72 Outcomes and COVID-19 Impact From the BRAAVE 2020 Study: a Randomized Switch to B/F/TAF in Black American Adults With HIV [Poster 802]. Paper presented at: 11th International AIDS Society (IAS) Conference on HIV Science Virtual; 18-21 July, 2021.
15. Iwuji C, Waters L, Milinkovic A, et al. Switching to bictegravir/emtricitabine/tenofovir alafenamide single tablet regimen from boosted protease inhibitor based ART in virologically suppressed adults with HIV 1 harbouring drug resistance: a Phase IV randomised, open label pilot study (PIBIK) [Poster P094]. Paper presented at: 19th European Aids Conference (EACS); October 18-21, 2023; Warsaw, Poland.
16. Lee SY, Lin YC, Chen CP, et al. Assessment of risk factors for virological nonsuppression following switch to dolutegravir and lamivudine, or bictegravir, emtricitabine, and tenofovir alafenamide fumarate in a real-world cohort of treatment-experienced adults living with HIV. PLoS One. 2024;19(11):e0314003.
17. Sabranski M, Vassallo M, Wet J, et al. Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Antiretroviral Treatment Naïve (TN) and Experienced (TE) People With HIV (PWH): 3 Year Effectiveness and Safety Outcomes in the BICST a R Observational Cohort. [Poster eP.A.081]. Paper presented at: The 19th European AIDS Conference; October,18–21, 2023; Warsaw, Poland.
18. Mican R, de Gea Grela A, Cadinanos J, et al. Impact of preexisting nucleos(t)ide reverse transcriptase inhibitor resistance on the effectiveness of bictegravir/emtricitabine/tenofovir alafenamide in treatment experience patients. AIDS. 2022;36(14):1941-1947.
19. Rolle CP, Nguyen V, Patel K, Cruz D, DeJesus E, Hinestrosa F. Real-world efficacy and safety of switching to bictegravir/emtricitabine/tenofovir alafenamide in older people living with HIV. Medicine. 2021;100(38):e27330.
20. Lamaizon C, Cecchini D, Bottaro E, et al. Effectiveness of bictegravir / emtricitabine/tenofovir alafenamide fixed-dose combination in experienced people living with HIV with a history of virologic failure, M184V /I, and other resistance-associated mutations in clinical practice [Poster PN097]. Paper presented at: 25th International AIDS Conference; July 22-26, 2024; Munich, Germany.
21. Chen GJ, Sun HY, Chang SY, et al. Effectiveness of second-generation integrase strand-transfer inhibitor-based regimens for antiretroviral-experienced people with HIV who had viral rebound. J Microbiol Immunol Infect. 2023;56(5):988-995.
22. Tsai MS, Sun HY, Chen CP, et al. Switching to coformulated bictegravir, emtricitabine, and tenofovir alafenamide maintained viral suppression in adults with historical virological failures and K65N/R mutation. Int J Infect Dis. 2023;126:39-47.
23. Shafran SD, Hughes CA. Bictegravir/emtricitabine/tenofovir alafenamide in patients with genotypic NRTI resistance. HIV Med. 2023;24(3):361-365.
24. Chamberlain N, Mena L, Brock JB. BIC/FTC/TAF Maintains Viral Suppression In Patients With Documented M184V/I Mutations: A Real World Experience [Poster 1003]. Paper presented at: ID Week Virtual; 21-25 October, 2020.

Abbreviations

3TC=lamivudine
ABC=abacavir
AE=adverse event
ARV=antiretroviral
BIC=bictegravir
BL=baseline
c/mL=copies/mL
DTG=dolutegravir
FTC=emtricitabine
INSTI=integrase strand transfer inhibitor
INSTI-R=integrase strand transfer inhibitor resistance
LOCF=last observation carried forward
NNRTI=non-nucleos(t)ide reverse transcriptase inhibitor
NNRTI-R=non-nucleos(t)ide reverse transcriptase inhibitor resistance
NRTI=nucleos(t)ide reverse transcriptase inhibitor
NRTI-R=nucleos(t)ide reverse transcriptase inhibitor resistance
PI=protease inhibitor
PI-R=protease inhibitor resistance
PR=protease
PWH=people with HIV
RAM=resistance-associated mutation
RT=reverse transcriptase
TAF=tenofovir alafenamide
TAM=thymidine analog mutation
TDF=tenofovir disoproxil fumarate
TFV=tenofovir
TE=treatment experienced
URTI=upper respiratory tract infection
VF=virologic failure
VS=virologically suppressed

Product Label

For the full indication, important safety information, and boxed warning(s), please refer to the Biktarvy US Prescribing Information available at:
www.gilead.com/-/media/files/pdfs/medicines/hiv/biktarvy/biktarvy_pi.

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