Phase 3 Data Suggest Cabenuva is Non-Inferior to Daily Biktarvy for HIV-1

A long-acting injectable regimen of cabotegravir and rilpivirine ([CAB+RPV LA] Cabenuva; ViiV Healthcare) may be as effective as traditional, once-daily bictegravir, emtricitabine, and tenofovir alafenamide ([BIC/FTC/TAF] Biktarvy; Gilead) for patients with HIV, according to the results of a study by ViiV Healthcare that was presented at the 30th Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle, Washington.

The SOLAR study is the first head-to-head study comparing the 2 HIV regimens. A participant survey revealed that 90% of patients who took every-2-month CAB+RPV LA preferred it to a once-daily medication.

“CAB+RPV LA administered every two months is as effective as BIC/FTC/TAF, while also addressing some important challenges associated with taking daily HIV treatment,” said primary investigator Moti N. Ramgopal, Midway Immunology and Research Center, Fort Pierce, Florida, in a press release.

The study identified CAB+RPV LA as an effective, well-tolerated, and satisfactory treatment among patients with virologically suppressive HIV (HIV-1 RNA ≥50 c/mL). The phase 3b, open-label, multicenter, non-inferiority (NI) SOLAR study evaluated 670 patients with viral suppression and currently treated with BIC/FTC/TAF. Patients were randomized 2:1, with the trial arm receiving CAB+RPV LA every 2 months and the other arm continuing with daily oral BIC/FTC/TAF.

The primary endpoint was NI efficacy of CAB+RPV LA in a proportion of HIV-1 RNA ≥50 c/mL, which CAB+RPV LA met. Among participants who filled out the HIV Treatment Satisfaction Questionnaire status, those in the CAB+RPV LA arm had stronger satisfaction ratings from baseline compared to patients in the BIC/FTC/TAF arm. Satisfaction came from not needing to remember to take a once-daily pill, its convenience, not having to worry about others seeing the pills, and not being reminded of HIV status, according to the survey.

The most common drug-related adverse events (AEs) were pyrexia (3%), headache (2%), fatigue (2%), and diarrhea (2%) in the CAB+RPV LA cohort, and weight gain (<1%) and abnormal hepatic function (<1%) in the BIC/FTC/TAF cohort.

CAB+RPV LA is indicated for patients with HIV-1 RNA <50 c/ml who are currently on an antiretroviral regimen and have no history of treatment failure. Cabotegravir is an integrase strand transfer inhibitor that prevents HIV replication.

Rilpivirine is a non-nucleoside reverse transcriptase inhibitor that stops HIV multiplication. Together, they are a complete regimen for treating HIV in this patient population.

“It’s essential that people living with HIV have treatment options that can help alleviate these burdens and we believe that complete long-acting regimens are here to help address some of those challenges today,” said Harmony P. Garges, MD, MPH, Chief Medical Officer at ViiV Healthcare, in the press release. “We are confident that cabotegravir, as part of a complete long-acting regimen, is a cornerstone for the long-acting treatment era in HIV medicine.”

Reference

GSK. ViiV Healthcare announces positive data demonstrating long-acting injectable Cabenuva (cabotegravir, rilpivirine) is as effective as daily oral Biktarvy (BIC/FTC/TAF) for the treatment of HIV-1. News Release. February 23, 2023. Accessed February 23, 2023. https://www.gsk.com/en-gb/media/press-releases/viiv-healthcare-announces-positive-12-month-findings-from-the-solar-study/