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MU-JHU roots for approval of injectable drug for HIV prevention

The medical researchers at Makerere University-John Hopkins University (MU-JHU) research collaboration have called for approval and licensing of Cabotegravir for use in Uganda’s health facilities.

The call was made by Dr Sheila Bamweyana, the study coordinator for HIV Prevention Trial Network-Long Acting Injectable for PrEP at MU-JHU offices in Mulago.

Approved by the United States Food and Drug Administration (FDA) in December 2021, Cabotegravir is a long-acting injectable drug that is effective in prevention of HIV acquisition in people who are at high risk.

Funded by the National Institute of Allergy and Infectious Diseases, Viiv Healthcare the pharmaceutical company making the injection, and Bill and Melinda Gates foundation, the research started in 2017 in South African and 2018 in Uganda. The study was conducted across 20 sites in sub-Saharan Africa in Uganda, Kenya, Botswana, South Africa, Eswatini, Malawi and Zimbabwe.

The study was conducted by MU-JHU, Baylor and UVRI. According to Dr Bamweyana, the research was premised on comparing effectiveness and safety on Cabotegravir and the Truvada daily oral pill. The pill was approved and is available for pre-exposure prophylaxis (PrEP) in health facilities in Uganda.

The results indicate that both Cabotegravir and Truvada are safe and effective in preventing HIV acquisition in highrisk women, however, Cabotegravir is superior.

“The results from both these studies were reviewed by the United States Food and Drug Administration (FDA) and they gave full approval on December 20, 2021 for use of Cabotegravir to prevent HIV in adults and youths who are at risk of HIV,” she said.

The researcher claims that all the necessary documents were submitted to the National Drug Authority (NDA) for review; however, the authority has not responded.

“We request for the NDA to review the information regarding Cabotegravir for PrEP and make the decision regarding its use within the country outside the research studies,” she said.

She said Cabotegravir injection is administered every two months and is effective for PrEP. It will be a good addition or option to the daily oral pill Truvada for PrEP as it helps in relieving the burden of swallowing the medicine on a daily basis.

Cabotegravir has been added into the national guidelines for PrEP; however, its actual availability to the people of Uganda will depend on the NDA approval and the funding from the government and donors.

Interviewed for this story Abiaz Rwamwiri, public relations manager of NDA, said they received an application from MU-JHU researchers for approval of Cabotegravir.

“I can confirm that the drug has gone through a scientific review and we are working with them to see that it meets all the required standards. The process of approving drugs is not a one man’s job because the drug is going to be used by millions of people so we don’t want to put their lives at risk. The team I will look into their issue,” he said.

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