Biktarvy® (BIC/FTC/TAF)

Comparison With CAB + RPV IM Q2M

This document is in response to your request for information regarding the efficacy and safety of Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide [BIC/FTC/TAF]) compared with cabotegravir and rilpivirine intramuscular injections once every 2 months (CAB + RPV IM Q2M) in people with HIV‑1 (PWH).

This document summarizes information from a study that was not sponsored by Gilead Sciences, Inc. For additional information regarding this study, please refer to its sponsor.

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

Clinical Data on BIC/FTC/TAF vs CAB + RPV IM Q2M

The SOLAR study was a phase 3b, randomized, open-label study that compared the efficacy and safety of CAB + RPV IM Q2M with BIC/FTC/TAF in virologically suppressed PWH.1

• At Month 12, CAB + RPV IM Q2M showed noninferior efficacy compared with BIC/FTC/TAF, with <1% of participants (1/223) receiving BIC/FTC/TAF and 1% of participants (5/447) receiving CAB + RPV IM Q2M demonstrating HIV-1 RNA ≥50 c/mL in the mITT-E population.
• No participants receiving BIC/FTC/TAF had CVF or treatment-emergent resistance. Three participants receiving CAB + RPV IM Q2M had CVF, 2 of whom had both INSTI and RPV (NNRTI) treatment-emergent resistance.
• Through Months 11 to 12, 1% of participants (2/227) receiving BIC/FTC/TAF and 72% of participants (327/454) receiving CAB + RPV IM Q2M experienced any drug-related AE.

Clinical Data on BIC/FTC/TAF vs CAB + RPV IM Q2M

Switch Onto Long-Acting Regimen (SOLAR) Study

Study design and demographics1

A ViiV-sponsored, phase 3b, randomized, open-label, multicenter, active-control, non‑inferiority study evaluated the safety and efficacy of CAB + RPV compared with BIC/FTC/TAF in virologically suppressed PWH. Participants with an undetectable HIV‑1 RNA (<50 c/mL) who had been on BIC/FTC/TAF as a first or second regimen for ≥6 months were randomly assigned in a 2:1 ratio to continue daily oral BIC/FTC/TAF or switch to CAB + RPV for 12 months. Participants who were assigned to receive CAB + RPV were able to choose to either start with a 1-month OLI or with SWI. Key exclusion criteria included any history of non-INSTI regimen and known or suspected presence of RAMs to any component BIC/FTC/TAF or CAB + RPV.

Figure 1. SOLAR: Study Design1

aOne prior INSTI-containing regimen was allowed if BIC/FTC/TAF was a second-line regimen >6 months prior to screening. Change in regimen must have been for safety/tolerability or reasons unrelated to treatment failure.

bExtension phase continued until CAB + RPV IM Q2M were either commercially available or locally approved, the participant no longer showed clinical benefit, or for other protocol-defined reasons.

cBased on the mITT-E population, which excluded 11 participants due to study site non-compliance with protocol entry criteria.

dDefined as two consecutive assays of HIV-1 RNA ≥200 c/mL.

Table 1. SOLAR: Baseline Demographics and Disease Characteristics
(mITT-E Population)1

Abbreviation: ART=antiretroviral treatment.

aTwelve transgender female participants, 1 transgender male participant, and 1 gender non-conforming participant were included.

Efficacy results

A total of 681 participants underwent randomization, and 670 participants were included in the mITT-E analyses. At Months 11 to 12, rates of virological suppression demonstrated noninferior efficacy of CAB + RPV IM Q2M compared with BIC/FTC/TAF. From baseline to Months 11 to 12, the median change in CD4 count was +20 and +39 cells/mcL in the BIC/FTC/TAF and CAB + RPV IM Q2M groups, respectively.1

Table 2. SOLAR: Efficacy Outcomes at Months 11 to 12 (mITT-E Population)1

From baseline through Month 12, viral blips were reported in 4% of participants in both the BIC/FTC/TAF group (n/N=9/223) and the CAB + RPV IM Q2M group (n/N=19/447); of the participants with viral blips, 11% (1/9) and 5% (1/19), respectively, had HIV-1 RNA ≥50 c/mL at Month 12. Neither of the 2 participants in the mITT-E population who received CAB + RPV IM Q2M and developed CVF had viral blips through Month 12.2

Resistance analysis through 12 months1,3

No participant who received BIC/FTC/TAF met the CVF criterion for resistance analysis. Two participants who received CAB + RPV IM Q2M in the mITT-E population had on‑treatment RAMs. One participant who developed on-treatment RPV (NNRTI) and INSTI RAMs at CVF later resuppressed during long-term follow-up on DRV/c, FTC, and TAF (Participant 1, Table 3). The second participant who developed RPV and INSTI RAMs at CVF also achieved viral resuppression on BIC/FTC/TAF followed by DRV/c, FTC, and TAF (Participant 2, Table 3).

A third participant from the ITT-E population who received CAB + RPV IM Q2M also met the CVF criterion and had RPV RAMs in the genotype at failure (Participant 3, Table 3), but it is unknown if these were present at baseline since the retrospective assessment of peripheral blood mononuclear cells was not successful. This participant later achieved viral resuppression on BIC/FTC/TAF.

The 3 participants who received CAB + RPV IM Q2M with CVF did not have late injections outside of the dosing window (+7 days). The participants’ plasma drug concentrations were above the respective paIC90 (CAB, 0.166 mcg/mL; RPV, 12 ng/mL) and phase 3 benchmarks (CAB, 0.65 mcg/mL; RPV, 17.3 ng/mL) at SVF timepoints.

Table 3. SOLAR: Participants With CVF Who Received CAB + RPV IM Q2M1,3

Abbreviation: FC=fold change.

Safety results1,3

Through Month 12, 1% of participants (2/227) who received BIC/FTC/TAF experienced any drug-related AE, compared with 72% (327/454) in the CAB + RPV IM Q2M group. AEs, excluding ISRs, are summarized in Table 4. A summary of ISRs reported by participants who received CAB + RPV IM (SWI and OLI groups) is shown in Table 5.

Table 4. SOLAR: AEs, Excluding ISRs, Through Month 12 (ITT Population)1,3

aDuring the OLI period (each, n=1): limb discomfort/paresthesia/dysesthesia, dizziness, fatigue, deafness/ear congestion/fatigue, participant-reported blood pressure fluctuation, and diarrhea/joint stiffness; during the IM injection period (each, n=1): myocardial infarction, increase in ALT, and fatigue/pyrexia.

bIncrease in ALT (n=2) and acute myocardial infarction (n=1).

Table 5. SOLAR: ISRs in CAB + RPV IM Q2M Groups (ITT-E Population)3a

aOne injection could be associated with multiple ISRs. Data on grading was missing for 1 ISR in the SWI group.

bNo Grade 4 or 5 ISRs were reported.

cIncluded 1 participant who discontinued due to ISR AEs, 1 participant who withdrew from the study secondary to injection intolerability, and 1 participant who was excluded from the primary analysis of the mITT‑E population for unknown reasons.

Weight change4

At Month 12, the median (IQR) weight change was +0.05 (-2.3 to +1.95) kg in the BIC/FTC/TAF group and -0.4 (-2.95 to +2.1) kg in the CAB + RPV IM Q2M group. By Month 12, a total of 4% of participants (9/213) in the BIC/FTC/TAF group and 3% of participants (11/408) in the CAB + RPV IM Q2M group experienced a weight increase of ≥10%. Changes in BMI remained numerically similar overall, and there were no clinically relevant changes in the proportion of participants with metabolic syndrome or insulin resistance from baseline through Month 12.

Treatment satisfaction5

The mean adjusted baseline HIVTSQs score was 58.38 for the BIC/FTC/TAF group and 57.88 for the CAB + RPV IM Q2M group. From baseline to Month 6, there was a ‑0.4 (95% CI: -1.41 to +0.61) change in score for the BIC/FTC/TAF group and a +3.86 (95% CI: 3.14–‍4.57) change in score for the CAB + RPV IM Q2M group, with an adjusted difference of 4.26 (95% CI: 3.02–5.49; P<0.001). From Month 6 to Month 12, there was a ‑1.59 (95% CI: -2.71 to -0.47) change in score for the BIC/FTC/TAF group and a +3.36 (95% CI: 2.59–‍4.13) change in score for the CAB + RPV IM Q2M group, with an adjusted difference of 4.95 (95% CI: 3.59–‍6.31; P<0.001). Changes from baseline to Month 12 in HIVTSQs scores reflected greater patient satisfaction in the CAB + RPV IM Q2M group than in the BIC/FTC/TAF group.

References

1. Ramgopal MN, Castagna A, Cazanave C, et al. Efficacy, safety, and tolerability of switching to long-acting cabotegravir plus rilpivirine versus continuing fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults with HIV, 12-month results (SOLAR): a randomised, open-label, phase 3b, non-inferiority trial. The lancet. HIV. 2023;10(9):e566-e577.

2. Latham C, Urbaityte R, Sutton K, Sutherland-Phillips D, Spreen W, D’Amico R. HIV-1 RNA Blips and Low-Level Viral Replication: SOLAR (CAB + RPV LA vs. BIC/FTC/TAF) [Poster 627]. Paper presented at: Conference on Retroviruses and Opportunistic Infections (CROI); March 03-06, 2024; Denver, CO.

3. Ramgopal MN, Castagna A, Cazanave C, et al. Efficacy, safety, and tolerability of switching to long-acting cabotegravir plus rilpivirine versus continuing fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults with HIV, 12-month results (SOLAR): a randomised, open-label, phase 3b, non-inferiority trial. [Supplementary Appendix]. The lancet. HIV. 2023;10(9):e566-e577.

4. Tan DHS, Antinori A, Eu B, et al. Weight and Metabolic Changes With Long-Acting Cabotegravir and Rilpivirine or Bictegravir/Emtricitabine/Tenofovir Alafenamide. J Acquir Immune Defic Syndr. 2025;98(4):401-409.

5. Ramgopal M, Castagna A, Cazaneve C. Solar 12-Month Results: Randomized Switch Trial of CAB+RPV LA vs Oral B/FTC/TAF. [Poster]. Paper presented at: Conferences on Retroviruses and Opportunistic Infections (CROI). 19-22 February 2023, 2023; Seattle, Washington.

Abbreviations

AE=adverse event
BIC=bictegravir
c/mL=copies/mL
CAB=cabotegravir
CD4=cluster of differentiation 4
CVF=confirmed virologic failure
DRV/c=darunavir/cobicistat
FTC=emtricitabine
HIVTSQs=HIV Treatment Satisfaction Questionnaire status version
IM=intramuscular
INSTI=integrase strand transfer inhibitors
ISR=injection site reaction
ITT-E=intent-to-treat exposed
mITT-E=modified intent-to-treat exposed
NNRTI=non-nucleos(t)ide reverse transcriptase inhibitor
OLI=oral lead-in


paIC90=protein-adjusted 90% inhibitory concentration
PWH=people with HIV
Q2M=once every 2 months
RAM=resistance associated mutation
RPV=rilpivirine
SOLAR=Switch Onto Long‑Acting Regimen
SVF=suspected virologic failure
SWI=start with injections
TAF=tenofovir alafenamide

 

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For the full indication, important safety information, and boxed warning(s), please refer to the Biktarvy US Prescribing Information available at:
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