The Joint Clinical Research Centre (JCRC) has unveiled promising 48-week study data indicating that a bi-monthly injectable HIV treatment is as effective as the standard daily oral HIV treatment regimen in African patients.
On Tuesday, JCRC Executive Director and chief investigator Dr. Cissy Kityo presented findings from a phase III clinical study evaluating the injectable treatment with Cabotegravir and Rilpivirine. The study demonstrated that this long-acting therapy matches the efficacy of daily oral antiretroviral treatments.
“The results support considering long-acting therapy for African treatment programs as a viable alternative to daily oral medicines for HIV-1,” Dr. Kityo stated. The Cabotegravir and Rilpivirine Efficacy and Safety (CARES) Study is the first of its kind to test injectable HIV treatment in Africa.
Dr. Kityo emphasized the transformative potential of the CARES trial, especially for patients who struggle with daily medication adherence.
“The findings from the CARES Trial are a huge step forward in HIV therapy in Africa. Long-acting injectable therapy not only has equivalent efficacy to daily oral regimens but is also more convenient for patients, which may improve adherence and quality of life. This could be a game-changer for our treatment plans as we move to achieve UNAIDS targets,” she observed.
She highlighted that the bi-monthly injectable regimen of Cabotegravir and Rilpivirine addresses one of the major barriers to effective HIV treatment: consistent medication adherence.
The study recruited participants from Kenya (162), South Africa (106), and Uganda (244), with the majority being of black race and a median age of 42 years. About 57.6 percent were female, and one in five participants had a body mass index of 30 or above, indicating a potential risk of suboptimal drug absorption. Participants had been on antiretroviral treatment for a median of eight years without a history of treatment failure.
Dr. Ivan Mambule, the CARES project lead at JCRC, noted the need for additional evidence to determine the role of long-acting therapy in treatment programs within a public health approach in sub-Saharan Africa.
“We needed additional evidence to determine the role of long-acting therapy in treatment programs with a public health approach in sub-Saharan Africa. There was a need to determine how effective this therapy would be against the wide range of circulating HIV subtypes and recombinants in the region,” he explained.
The study highlighted that a significant portion of people with HIV in Africa are women, who may have differences in body fat distribution compared to men. “Higher levels of body fat can affect the absorption of the drugs when injected into the buttock muscle and this may affect responses to Cabotegravir and Rilpivirine,” scientists noted.
Dr. Kityo added that longer-term follow-up on the study is continuing to week 96, indicating that this demonstration of safety and efficacy is a crucial first step toward discussing the potential role of long-acting treatment programs in sub-Saharan Africa.