Uganda to test pill taken once a month to prevent HIV

Apr 05, 2021

The new drug, an antiretroviral (ARV) called Islatravir, has already shown promise as a once-monthly oral PrEP in earlier studies on a few people.

To join the study, one has to be HIV negative, sexually active, female, between 16 to 45 years of age, not pregnant or breastfeeding and willing to use contraception.

Hilary Bainemigisha
Editor @New Vision

HEALTH | HIV | TEST PILL

KAMPALA - Uganda is going to participate in a third phase trial of a drug, to see if it can protect a person from getting an HIV infection when swallowed once a month.

In the process of drug development, the third phase tests a potential drug on many people to study its safety and effectiveness.

The new drug, an antiretroviral (ARV) called Islatravir, has already shown promise as a once-monthly oral PrEP in earlier studies on a few people.

PrEP is a pre-exposure prophylaxis or a drug that you take when you are not infected to prevent that infection from entering your body. Use of PrEP in HIV started in the US in 2012, with Truvada and in Uganda, it was rolled out in 2015.

Dr Brenda Gati Mirembe of Makerere University – John-Hopkins University (MU-JHU) Research Collaboration, said the study will be conducted among 4,500 women, aged 16-45, who are HIV negative but are at high risk of acquiring it.

“In Uganda, we are looking for about 200 women and girls. Apart from Makerere University – John-Hopkins University, the study will also be conducted in multiple sites in the US and other sites in sub-Saharan Africa. This helps because when the results are good, the fi findings can apply to the global community.

In Africa, the study will be carried out at sites in Malawi, Kenya, Zambia, Zimbabwe and South Africa,” Dr Gati, who is a senior investigator for the study at Makerere University – JohnHopkins University Care, said.

Dr Gati, who has over 10 years’ experience in HIV prevention research among women and adolescent girls, told stakeholders meeting at MUJHU, located in Mulago, that the study will recruit participants from Kampala and the surrounding districts.

“We shall focus on pockets of key populations according to the HIV incident mapping,” she said.

This comes shortly after a long-acting injectable, Cabotegravir, proved to be highly effective in protecting a person from HIV infection when taken once every eight weeks. The trial, called HPTN 084, studied 3,223 participants from 20 sites across seven countries in sub-Saharan Africa.

These included three sites in Uganda, (MU-JHU, Baylor Uganda and UVRI/IAVI) and other sites in Kenya, Botswana, Malawi, South Africa, Eswatini and Zimbabwe.

Dr Clemensia Nakabiito, who is the investigator in MU-JHU said: “The higher-than-expected level of adherence to both drugs in the study and the overall low incidence rate in both arms of the study clearly demonstrated that both Cabotegravir and Truvada were highly effective at preventing HIV acquisition,” If Islatravir works, it will be an addition to the HIV prevention methods one can choose from to protect themselves.

Dr Gati said findings from earlier phase trials done among few participants have shown that Islatrvair is well-tolerated, and not susceptible to ARV drug resistance if one got HIV while taking this drug.

“It works by preventing the HIV virus from making copies of itself,” she said.

Islatravir is produced by Merck Sharp and Dohme, a subsidiary of Merck & Co, Inc, which has been at the forefront of research to prevent and treat diseases such as cancer, HIV and Ebola.

Additional funding for the study is provided by Bill & Melinda Gates Foundation through the University of Washington International Clinical Research Center that secured this funding.

The study, which is referred to as Impower-022, will compare Islatravir with daily Truvada, an already proven PrEP drug in a randomised, active-controlled and double-blind study design.

“The study will last between one to three years. To join the study, one has to be HIV negative, sexually active, female, between 16 to 45 years of age, not pregnant or breastfeeding and willing to use contraception. We appeal to those willing to cast their stone at HIV to give it a shot,” Dr Gati said.

Interested participants will be invited to Makerere University – JohnHopkins University for screening when the study is about to start — hopefully before end of the third quarter 2021. 

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