The Joint Clinical Research Centre (JCRC) has announced a 48-week study data showing that two monthly injectable HIV treatments is as effective as the standard daily oral HIV treatment combination in African patients, per a scientific investigation.

On Tuesday, JCRC Executive Director and chief investigator Dr Cissy Kityo said results from a phase III clinical study evaluating injectable treatment with Cabotegravir and Rilpivirine compared to standard oral antiretroviral treatment taken daily.

“The results support consideration of long-acting therapy for African treatment programs as a viable alternative to daily oral medicines for HIV-1.The long-acting therapy is a promising solution for improving adherence and quality of life among HIV-1 patients in the region,” she said.

The Cabotegravir and Rilpivirine Efficacy and Safety (CARES) Study is the first test of injectable treatment in people with HIV in Africa.

Dr Kityo highlighted the transformative potential of the CARES trial findings, especially for patients who struggle with adherence to daily medication.

"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.

Dr Kityo emphasized that the long-acting injectable regimen of Cabotegravir and Rilpivirine offers a significant advantage by reducing the frequency of dosing from daily to bi-monthly, thus “addressing one of the major barriers to effective HIV treatment which is consistent medication adherence.”

JCRC says this “convenience is expected to lead to better health outcomes and greater viral suppression rates.”

About study

Figures by JCRC suggest that the said study recruited participants in Kenya (162), South Africa (106) and Uganda (244). Majority were of black race with 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 taking antiretroviral treatment for a median of eight years but had no history of treatment failure.

Dr Ivan Mambule, the CARES project lead at JCRC remarked that the populations in the regions where previous registration studies were performed differ greatly from the people living with HIV (PLWH) in 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 on Tuesday.

Additionally, majority 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 absorption of the drugs when injected into the buttock muscle and this may affect responses to Cabotegravir and Rilpivirine,” scientists said in Kampala.

Dr Kityo added that longer term follow up on the study is continuing to week 96.

This demonstration of safety and efficacy of the bi-monthly treatment is considered an essential first step to discussing a potential role for long-acting treatment programs in sub-Saharan Africa, using the public health approach.