Background:
Long-acting antiretroviral therapy (LA-ART) with cabotegravir (CAB) and rilpivirine (RPV) was recently approved in the U.S., but real-world data from demonstration projects are lacking. LA-ART was approved for treatment naïve or experienced patients with virologic suppression (VS) on oral ART for at least 5 months prior to switching to injectables. However, patients with adherence challenges unable to achieve or maintain VS with oral medications may also benefit.
Methods:
The Ward 86 HIV Clinic is a safety-net clinic in San Francisco serving publicly-insured patients. The overall rate of VS in the clinic (n=2600) is 88%. To maximize potential benefit of LA-ART, we offered direct-to-inject LA-ART for persons with and without VS. Eligibility required willingness to receive LA-ART every 4 weeks; a history of resistance mutations to RPV or >1 mutation to CAB were exclusion criteria. Injections were given in clinic with drop-in access with rare injections provided in the community via street medicine. We present descriptive statistics and a Kaplan Meier (KM) curve to estimate time to VS (< 30 copies/mL) for those without VS.
Results:
From November 2020-August 2022, we started 94 patients on LA-ART: median age 44 (range 28-69) years; 85% male, 10% female, 5% transgender/non-binary; 40% White, 13% Black, 36% Hispanic, 11% Other. Of the 94, 31% were homeless, 68% reported active substance use, and 45% had a major mental illness. In the study population, 47 had initial VS on oral ART; 43 were viremic [HIV RNA median 4.5 log, IQR: 2.8 to 5.1], with only 7 having a prior history of VS on oral ART; and 4 did not have a recent viral load; 67/94 patients had on-time injections throughout; 24 had 1 and 3 had ≥2 late injections; 4 received out-of-clinic injections. All 47 patients with VS stayed suppressed on LA ART. All patients without initial VS achieved viral loads (VL) < 30; median weeks to VS was 6.9 (95% CI 4 to 12.9). KM analysis estimates a probability of 0.962 of reaching VS by 28 weeks (Figure). By 42 weeks, 100% had reached VS with one patient exhibiting low-level viremia until undetectable.
Conclusions:
We report a demonstration project of using LA-ART on a population of PLWH inclusive of those without virologic suppression with high rates of substance use, homelessness, and mental illness. LA-ART led to VS in all patients not initially suppressed. LA-ART may be indicated for patients with adherence challenges unable to achieve or maintain viral suppression on oral ART to extend its benefits.
KM curve of reaching virologic suppression for non-virologically suppressed patients on long-acting ART