Kampala, Uganda | THE INDEPENDENT | Researchers at Makerere University – John Hopkins Research Collaboration (MU-JHU) are embarking on a new study to establish the effectiveness of using the new HIV drug, Islatravir in HIV prevention as a Pre-exposure Prophylaxis (PrEP).
Dr Gatti Brenda Mirembe, the principal investigator on the study says that HIV negative women at high risk of HIV infection will be enrolled on a monthly pill to evaluate its effectiveness and safety in protecting them from acquiring the virus. The study will also be carried out in Kenya, Botswana, Eswatini, Malawi, South Africa, Zimbabwe, and the United States.
Brenda says that the drug will be compared with the already rolled out oral PrEP drug truvada.
Dubbed IMPOWER – 022 study, the researchers aim to enroll a total of 4,500 women aged 16 to 45 years and 200 of them will be followed up from the Mulago Hill-based facility.
Mirembe says the earliest enroller will be in the trial for three years and the latest for a year noting that they resolved to include young women because the prevalence of HIV is much higher in those age groups.
Currently, she says they are engaged in study approval processes with research regulators to ensure that actual work starts by September. She is optimistic that once successful, this drug will be a game-changer in HIV prevention as it gives the public choices especially those that can’t manage taking the only PrEP option so far approved for use in Uganda, with a daily pill and yet they are at high risk of infection.
However, as the new drug is being highly anticipated, already the facility has done studies on other PrEP options such as the Cabotegravir injection and the dapivirine vaginal ring that are yet to be rolled out for general use even as studies found them to be effective in preventing infection.
For the dapivirine ring for instance, the World Health Organisation (WHO) recommended its use and issued guidelines for its general roll out in January but it’s still unavailable in many countries including Uganda.
Estimated to cost 29,000 Shillings, officials in the Ministry of Health say the monthly ring is still expensive for the country to consider and therefore so far they have not yet started on the national guidelines even as WHO has given it a nod.
Uganda also still struggles to enroll all the people at high risk of infection who need the daily Truvada. It’s estimated that between 67,000 and 68,000 people are enrolled currently, lower than the year 2020 target that had been set at 90,000 people.
Also, the country recorded a high 48,000 new HIV infections last year, a figure experts say can be greatly reduced by prevention methods such as PrEP.
Dr Clemensia Nakabiito, one of the earliest researchers of HIV in women in Uganda says it’s frustrating for researchers to continue bringing up innovations that can’t be adopted. She says they haven’t heard from the Ministry about how soon the ring for instance will be adopted and yet study participants keep frequenting them with questions.
Ruth Nahurira, a former PrEP trial participant urges the Ministry of Health to speedily approve methods that are proven effective in the research.
Nahurira who is excited by the news of the IMPOWER study says that it will offer people more options to choose from.
To her so far, the ring is the option a woman can easily use without their partner’s consent since she doesn’t have to hide medicine tins or being spotted swallowing.
“I was excited by the ring. I asked a lot of questions about it and doctors told me little of that medicine ends in the bloodstream. The medicine goes mainly to that place that it’s supposed to protect”, she said calling upon MOH to embrace all options of prevention if the country is to make gains in the HIV targets.
Meanwhile, the new drug Islatravir has already been found to be well-tolerated and efficacious in offering protection against HIV in smaller studies carried out abroad.
Among people who take it as a treatment for HIV, it’s classified as nucleoside reverse transcriptase translocation inhibitor (NRTTI) and therefore works to stop virus replication.