ViiV Healthcare and Janssen backed a single-patient request program where doctors could seek compassionate use of oral and long-acting (LA) cabotegravir + rilpivirine for persons living with HIV-1.  Parenteral therapy requirement, lack of primary resistance mutations to cabotegravir or rilpivirine, and documented treatment retention were the inclusion criteria. Standardized program applications and quarterly clinical updates were mined for demographic, effectiveness, and safety information. Individuals received a loading dose of LA cabotegravir 600 mg + rilpivirine 900 mg, followed by LA maintenance doses of 400 mg/600 mg every 4 weeks; some received lead-in oral cabotegravir and rilpivirine. Through July 2020, 35 people living with HIV-1 had data available.  Chronic non-adherence due to psychological disorders was cited as the most common justification for compassionate usage (n=15). Out of the 35 patients living with HIV-1, 16/28 achieved or maintained virological suppression at data cutoff, and 7 were virologically suppressed upon program admission (median viral load 60,300 copies/mL). About 6 patients with HIV-1 who had detectable viremia at commencement were among the 7 people who stopped treatment early due to an inadequate virological response. Among those 6, new mutations in either reverse transcriptase or integrase were present in 4. Among the 6 significant adverse events that did not end in death, 2 were thought to be probably caused by the medication. There were 4 deaths, although the treatment didn’t cause them. A single person reported about 2 pregnancies and ongoing LA use. Most HIV-1 patients who received or are now receiving LA therapy had an advanced illness (16/28) and either achieved or sustained virological suppression (6/7). Compassionate use of cabotegravir LA + rilpivirine LA was a beneficial treatment option for people who had trouble sticking to oral therapy and were in late-stage HIV infection.

Source: onlinelibrary.wiley.com/doi/10.1111/hiv.13370