Fostemsavir for heavily-treatment experienced individuals

There continues to be a need for new drugs for people who have few treatment options. BRIGHTE is an ongoing Phase 3 study evaluating fostemsavir (FTR) in heavily treatment-experienced (HTE) patients with multidrug resistant HIV who are unable to form a viable antiretroviral (ARV) regimen. FTR is a prodrug of temsavir (TMR), a first-in-class, investigational attachment inhibitor, which binds directly to the virus, and not immune cells, thereby blocking infection.

People in the study took fostemsavir along with other HIV medications. Use of investigational agents was permitted as part of the optimized background regimen for study participants, which is important for those who have few options. After 96 weeks more than half of those in the study had an undetectable viral load, and many had significant gains in CD4 T cells. The drug continues to be generally safe and well tolerated.

Vaginal ring continues to show promise

An open-label study of women in four countries in southern and eastern Africa, using a vaginal ring that is inserted once a month and slowly releases the antiretroviral drug dapivirine, was estimated to reduce HIV risk by 39%. HOPE, an extension of the ASPIRE study, showed that adherence was higher than in previous studies.

While the study was not designed to prove efficacy, acceptance of the ring was high (92%) at baseline and continued throughout the study, with 79% at nine months. Eighty-six percent of returned rings showed drug levels that demonstrated high adherence.

“Effective and safe HIV prevention options continue to be needed the world over but particularly for women at risk for acquiring HIV,” Jared Baeten, MD, PhD professor of global health, medicine, and epidemiology at the University of Washington, told Infectious Disease News. “The more options that are developed and used, the better chance we have to turn the tide on the global HIV epidemic.”

Long-acting cabotegravir + rilpivirine demonstrates high level of acceptance

New modes of treatment are needed to improve adherence and provide additional options for people living with HIV. Long-acting cabotegravir plus long-acting rilpivirine (CAB LA + RPV LA) is being studied for treatment of HIV once or twice monthly. The Phase 3 ATLAS study found that switching to CAB LA + RPV LA was non-inferior to a three-drug oral ART regimen at 48 weeks in individuals who are undetectable and have no history of resistance.

Patient-reported outcomes (PRO) tools were used to assess patient views on switching to CAB LA + RPV LA or continuing baseline oral ART, and suggested that long-acting treatment was well tolerated through 48 weeks. Health status and quality of life (QoL) were similar between the LA and oral ART groups. Treatment acceptance was significantly higher with LA compared to oral ART: 90% of patients receiving LA treatment scored injection site reactions (ISRs) as totally or very acceptable and 86% scored pain as totally or very acceptable. Ninety-seven percent of patients receiving LA treatment said they preferred LA treatment to daily oral therapy.

ViiV Healthcare submitted a new drug application (NDA) to the FDA in April of this year, and if approved, cabotegravir plus rilpivirine would be the first-ever long-acting, injectable treatment regimen for adults living with HIV.