Kampala, Uganda | THE INDEPENDENT | A new HIV Pre-exposure Prophylaxis (PrEP) study is underway to establish whether a six months-long injectable drug, Lenacapavir (LEN), and oral drug Descovy can protect HIV negative women and girls from acquiring the virus.
The two-part study is being done by a team of researchers at Makerere University – John Hopkins University Research Collaboration (MUJHU). The study will involve estimating the HIV incidence in the areas where the study will be conducted while the efficacy of the drug will be determined in part B of the trial.
Dr Alex Kintu, a member of the team of researchers said that the study is happening at sites in Kalangala, Masaka, Mityana, Mubende, Kapeeka, Lwamata and Hoima.
Kintu says that unlike previous incidents where researchers were inviting negative participants at risk of infection to participate, this time, they will randomly study sexually active women from the community who have not done a test in the last six months and don’t know their status.
Study participants will be given one injection and one pill periodically to determine efficacy, where they will also compare the effectiveness with Truvada which is the only option in use currently. The same study will also happen in South Africa with a total of 5,010 participants expected to be analyzed.
In Uganda, Dr Flavia Matovu Kiweewa, the new study lead based at MUJHU says they are currently in the process of approving study sites adding that with Truvada currently in use, there are a lot of gaps regarding the roll-out. These include low uptake, reduced bone density, and poor adherence.
“Long-acting formulations like the six-monthly injection will address most of these barriers to PrEP uptake,” she says. Scientists say that the new pill descovy is smaller, stable in plasma and therefore has fewer effects on the kidney.
However, even as PrEP is being promoted worldwide for HIV prevention including in Uganda where early studies that confirmed the effectiveness of Truvada were done, only 52,000 people are so far enrolled. The country had planned to enroll at least 90,000 eligible people by the end of 2019, a target they never met.
Dr Joseph Kagai, the Executive Director of Rakai Health Sciences Programme where most of Uganda’s HIV research has been done says only 60 percent of those eligible for PrEP can access it in the country. He adds that coverage has been very low in previous years and that some 13,000 people have just been enrolled.
He says while HIV prevalence had been to the highs of 40 percent, in the fishing communities with much higher levels than trading centres, the incidence declined greatly with the mix of prevention interventions to include PrEP and voluntary medical male circumcision. However currently, overall, 47 districts in Uganda have access to PrEP and the target according to Kagai is to reach 50 districts this year.
Dr Joshua Musinguzi who heads the AIDS Control Programme in the Ministry of Health told URN that even as enrollment levels are still that low, they are already experiencing challenges of people not adhering to PrEP. He says this may point to a fact that some people may not be very comfortable with Truvada or a daily pill. For him, more long-acting interventions will come in handy.
Recently, preliminary results of interventions such as cabotegravir injection are giving hope. For instance, an interim analysis of an ongoing HIV prevention study whose results were released early this month showed that long-acting injectable cabotegravir administered every two months is 89 percent more effective than daily pills in preventing HIV acquisition in women at risk of infection.