Sunlenca® (lenacapavir)

Optimized Background Regimens in the CAPELLA Study

This document is in response to your request for information regarding Sunlenca® (lenacapavir [LEN]) and optimized background regimens (OBR) used in the CAPELLA study.

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/sunlenca/sunlenca_pi.

Product Labeling1

Indications and usage

LEN, an HIV-1 capsid inhibitor, in combination with other ARV(s), is indicated for the treatment of HIV-1 infection in HTE adults with multidrug resistant HIV-1 infection failing their current ARV regimen due to resistance, intolerance, or safety considerations.

Clinical studies

The efficacy and safety of LEN in HIV-1 infected, HTE participants with multidrug resistant HIV-1 is based on 52-week data from CAPELLA, a randomized, placebo-controlled, double‑blind, multicenter trial (NCT04150068).

CAPELLA: LEN in HTE PWH

Study Design and Demographics

CAPELLA (NCT04150068) is an ongoing, phase 2/3, double-blinded, PBO controlled clinical study designed to evaluate LEN as add-on therapy to a failing regimen in HTE PWH with multidrug resistance. According to the change in the HIV-1 RNA level between the screening and cohort-selection visits, participants were either enrolled in the randomized cohort or the non-randomized cohort. Participants in the randomized cohort were assigned to receive oral LEN or PBO in a 2:1 ratio for 14 days, in addition to continuing their failing regimen. The non-randomized cohort started LEN (2-week oral initiation then SUBQ) with an OBR (Figure 1). Both cohorts are part of the maintenance phase evaluating the safety and efficacy of SUBQ LEN administered every six months in combination with an OBR.2,3

Figure 1. CAPELLA: Study Design3-6

aParticipants with <0.5 log10 decline in HIV-1 RNA and HIV-1 RNA ≥400 c/mL were enrolled in the randomized cohort; participants were enrolled in the non-randomized cohort if they had ≥0.5 log10 decline in HIV-1 RNA and/or had HIV-1 RNA <400 c/mL or were enrolled after the randomized cohort was fully recruited.

bOral LEN dosing schedule: Day 1, 600 mg; Day 2, 600 mg; and Day 8, 300 mg.

cSUBQ LEN dosing schedule: 927 mg (2 × 1.5 mL) on Day 15 and then every 6 months.

Note: ATV, ATV/cobicistat, ATV/ritonavir, efavirenz, ETV, nevirapine, and tipranavir were not permitted for use in OBR.

The primary endpoint was the proportion of participants who achieved a ≥0.5‑log10 c/mL reduction in HIV‑1 RNA from baseline to the end of the functional monotherapy phase in the randomized cohort. Secondary endpoints included the percentage of participants in the randomized cohort with HIV-1 RNA <50 c/mL and <200 c/mL at Week 26.2

Baseline characteristics are provided in Table 1.

Table 1. CAPELLA Study: Baseline Demographics and Disease Characteristics2,4

Abbreviation: CD4=clusters of differentiation 4.

aPercentages may not equal to 100 due to rounding.

bRace was reported by the participants. Collection of race or ethnicity data was prohibited by local regulators for 1 participant in the PBO group and was excluded from the denominator of the percentage calculation.

cTwo participants in the non-randomized cohort had HIV-1 RNA >400 c/mL at screening but <50 c/mL at enrollment.

Twenty‑two percent of all participants (16/72) did not have changes in their OBR before they entered the open-label maintenance phase; the ARV classes and agents that comprised the failing regimen and OBR are shown in Table 2.7

Table 2. CAPELLA Study: Composition of Failing Regimens and OBR8

Abbreviation: OSS=overall susceptibility score.

aOSSs were calculated with a proprietary algorithm (Monogram Biosciences Inc.), and investigators provided data for scoring from historical resistance reports. An OSS of 1 indicated full susceptibility, 0.5 indicated partial susceptibility, and 0 indicated no susceptibility. The OSS of the OBR was the total sum of the individual scores.

Individual OBRs for all 72 participants can be found in Table 3.

Table 3. CAPELLA Study: OBRs for Each Participant (N=72)9 

Abbreviations: 3TC=lamivudine; ABC=abacavir; AZT=zidovudine; BIC=bictegravir; DOR=doravirine; DRV=darunavir; DTG=dolutegravir; ID=identification; FPV=fosamprenavir; FTC=emtricitabine; Part.=participant; RAL=raltegravir; RPV=rilpivirine; TAF=tenofovir alafenamide; TDF=tenofovir disoproxil fumarate.

aParticipant 31 discontinued T20 after 1 week.

References

1. SUNLENCA, Gilead Sciences Inc. SUNLENCA® (lenacapavir) tablets, for oral use. SUNLENCA® (lenacapavir) injection, for subcutaneous use. US Prescribing Information. Foster City, CA.
2. Segal-Maurer S, DeJesus E, Stellbrink HJ, et al. Capsid Inhibition with Lenacapavir in Multidrug-Resistant HIV-1 Infection. N Engl J Med. 2022;386(19):1793-1803.
3. Molina JM, Segal-Maurer S, Stellbrink HJ, et al. Efficacy and Safety of Long-Acting Subcutaneous Lenacapavir in Phase 2/3 in Heavily Treatment- Experienced People with HIV: Week 26 results (CAPELLA study) [Presentation]. Paper presented at: 11th International Aids Society (IAS) Conference on HIV Science Virtual; 18-21 July, 2021.
4. Ogbuagu O, Segal-Maurer S, Brinson C, et al. Long-Acting Lenacapavir in People With Multidrug-Resistant HIV-1: Week 52 Results [Poster 1047]. Paper presented at: Virtual Conference on Retroviruses and Opportunistic Infections (CROI) 2022; 12-16 February, 2022.
5. ClinicalTrials.gov. Study to Evaluate the Safety and Efficacy of Lenacapavir in Combination With an Optimized Background Regimen in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance (CAPELLA). ClinicalTrials.gov Identifier: NCT04150068. Available at: https://clinicaltrials.gov/ct2/show/NCT04150068. Accessed: 30 July 2020. Last Updated: 23 July. 2020.
6. Gilead Sciences Inc. Data on File.
7. Ogbuagu O, Segal-Maurer S, Ratanasuwan W, et al. Efficacy and Safety of Long-Acting Subcutaneous Lenacapavir in Heavily Treatment-Experienced People With Multi-Drug Resistant HIV: Week 52 Results [Oral Presentation 1585]. Paper presented at: Infectious Diseases Society of America ID Week; 19–23 October, 2022; Washington, D.C., US.
8. Stellbrink H, DeJesus E, Segal-Maurer S, et al. Subgroup Efficacy Analyses of Long-Acting Subcutaneous Lenacapavir in Heavily Treatment-Experienced People With HIV in the Phase 2/3 CAPELLA Study [Poster]. Paper presented at: 18th European AIDS Conference (EACS); October 27-30, 2021; London, UK.
9. Margot NA, Naik V, VanderVeen L, et al. Resistance analyses in Highly Treatment-Experienced People with HIV Treated with the Novel Capsid HIV Inhibitor Lenacapavir [Supplementary Tables]. J Infect Dis. 2022:1-7.

Abbreviations

ARV=antiretroviral
ATV=atazanavir
c/mL=copies per mL
EI=entry inhibitor
ETV=etravirine
FTR=fostemsavir
HTE=heavily treatment-experienced
IBA=ibalizumab
INSTI=integrase strand transfer inhibitor
LEN=lenacapavir
MVC=maraviroc
NNRTI=non-nucleos(t)ide reverse transcriptase inhibitor
NRTI=nucleos(t)ide reverse transcriptase inhibitor
OBR=optimized background regimen
PBO=placebo
PI=protease inhibitor
PWH=people with HIV
SUBQ=subcutaneous(ly)
T20=enfuvirtide

Product Label

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

Follow-Up

For any additional questions, please contact Gilead Medical Information at:

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