Compassionate use of antiretroviral therapy (ART) with long-acting (LA) cabotegravir plus rilpivirine among patients with advanced HIV infection increased the rate of achieving or maintaining virologic suppression, according to study findings published in HIV Medicine.
The compassionate use program for ART with LA cabotegravir plus rilpivirine was available in 10 countries across Europe, North America, and Asia, in which clinicians could request medications from ViiV Healthcare and Janssen for a patient. Requests for inclusion in the program were reviewed on a case-by-case basis by clinicians. Eligibility criteria included the need for parenteral therapy, no presence of a drug resistant mutation, and established treatment retention. This study evaluated the safety and efficacy of this program.
A total of 35 patients were included in this analysis, of whom 57% were women, the median age was 36 (range, 20-67) years, 31% were perinatally infected, and 66% had AIDS, respectively. In addition, the median number of previously used ART regimens among the patients was 4 (range, 1-10), 80% had detectable HIV viral loads, the median CD4+ count was 100 (range, 3-918) cells/mm3, and 34% did not have an oral lead-in.
Reasons for compassionate use requests included psychologic need (n=15), psychical challenges (n=8), malabsorption (n=6), limited cognitive skills (n=3), and dysphagia (n=3).
After a median follow-up period of 10 months, most patients (63%) achieved or maintained virologic suppression, defined as an HIV RNA viral load of less than 50 copies/mL. Of the 13 patients who did not achieve virologic suppression, 2 (15%) had not yet received LA injections, and 1 (8%) had initiated the compassionate use program less than 4 months before the analysis.
Among 7 patients who discontinued therapy due to an incomplete virologic response, 6 had detectable viremia at baseline, and all were found to have resistant mutations that were not detected prior to program entry.
The most common adverse events were pain (34%) and nodule formation (9%). Severe adverse events included incarcerated hernia, cryptococcal meningitis or immune reconstitution inflammatory syndrome, loss of consciousness or abnormal behavior, right inguinal abscess, and right nasal vestibulitis.
Limitations of this study include the small sample size, as well as the lack of both a comparator cohort and inclusion of statistical analyses.
According to the researchers, “access to LA ART may also be attractive to individuals with adherence challenges with oral therapy.”
Disclosure: This research was supported by ViiV Healthcare, and multiple authors declared affiliations with industry. Please see the original reference for a full list of disclosures.
D’Amico R, Gomis SC, Moodley R, et al. Compassionate use of long-acting cabotegravir plus rilpivirine for people living with HIV-1 in need of parenteral antiretroviral therapy. HIV Med. Published online August 9, 2022. doi:10.1111/hiv.13370