San Francisco Clinic Cohort Tests Off-Label Injectable HIV Regimen
Clinicians are already starting to use these two drugs together, and until now we’ve had very little evidence to guide us,
said Dr. Monica Gandhi regarding a new retrospective case series from San Francisco General Hospital. Investigators at the facility’s Ward 86 HIV Clinic evaluated an off-label switch strategy pairing long-acting lenacapavir with cabotegravir, with or without rilpivirine, for patients facing adherence challenges and drug resistance.
The evaluation, which reviewed electronic medical records for patients starting the treatment between March 2023 and May 2025 with follow-up extending through November 2025, found that all 46 participants maintained or achieved viral suppression. Managed Healthcare Executive reported that the cohort had a mean age of 47.1 years, with nearly 70 percent identifying as men, and included significant populations facing unstable housing or substance use.
Viral Suppression Results in Treatment-Experienced Patients
At the start of the lenacapavir regimen, 22 patients were virally suppressed while 24 were viremic, defined as having an HIV RNA level of 200 copies/mL or more. More than half of those viremic patients had a baseline CD4+ count of 200 cells/mm³ or lower, according to Managed Healthcare Executive. Furthermore, 71.7 percent of the cohort exhibited baseline non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance.
All patients who began the treatment while suppressed remained suppressed, and every patient who started viremic achieved viral suppression by 13 weeks. Over a median follow-up period of 100 weeks from the first lenacapavir injection, no patient experienced consecutive viral loads above 200 copies/mL. Lenacapavir itself is a first-in-class capsid inhibitor approved in 2022 for multidrug-resistant HIV, acting at several discrete steps of the viral life cycle.
Demographic and Infrastructure Context of the Ward 86 Study
The patient group reflected significant social vulnerabilities alongside complex medical histories. Nineteen participants, or 41.3 percent, experienced unstable housing such as shelters or single-room occupancy hotels, while 15 patients reported current methamphetamine or amphetamine use. The study authors noted that Ryan White Program-funded clinics typically report higher viral suppression rates of 91.4 percent compared to the U.S. national average of 67.2 percent, supported by CDC data.
Because of this specialized support infrastructure, the researchers cautioned that the findings may not generalize broadly across all clinical settings. Nationally, the Centers for Disease Control and Prevention reported that 68.5 percent of people with diagnosed HIV were virally suppressed in 2024. While cabotegravir and rilpivirine is currently the only complete long-acting antiretroviral regimen approved in the U.S., formal clinical trials through the Advancing Clinical Therapeutics Globally network are planned to further examine the lenacapavir and cabotegravir combination.
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