The investigating team carrying out clinical studies for the injectable ARVs has started lobbying funders and financiers amid the hope that this innovative therapy will be adopted as part of treatment guidelines for HIV.
The team led by chief investigator Dr Cissy Kityo is ecstatic with the results so far from the studies which are being carried out in Kenya, Uganda and South Africa; Uganda being the coordinating centre.
Dr Kityo, who is also the Executive Director Joint Clinical Research Centre (Uganda), the sponsor of the study, said all the 512 participants have already been recruited.
Janssen Pharmaceuticals, which belongs to Johnson & Johnson, is the financier of the study.
The study is being carried out in three centres in Kenya namely: The Aga Khan University Hospital-Nairobi, Kenya Medical Research Institute (Kemri)-Kericho and Ampath in Uasin Gishu.
Both Ampath and Kemri have 67 participants each while The Aga Khan University Hospital has 40.
The first participant in Kenya was dosed in March of this year at The Aga Khan University Hospital while in Uganda this was done in September 2021.
- Kemsa shelves ARVs over safety concerns
- It was like walking with death on your head
- More Kenyans discuss their HIV status with their partners, study finds
- Kenya ramps up efforts to curb HIV infections among youth
“We have now recruited all the 512 and we are doing follow-up. We have patients that have reached month 15, on the whole, the study is moving smoothly,” said Dr Kityo who gave an update on the study during a meeting in Nairobi.
Dr Kityo said the team is already looking forward to how the findings of the study will translate to actual access of the injectable ARVs.
“We are already talking to World Health Organisation(WHO), even Janssen the funders are talking to WHO, and we are starting a discussion with partners like Pepfar and Global Fund to come on board when it is here,” said Dr Kityo.
The United States President’s Emergency Plan for AIDS Relief (Pepfar) and Global Fund are the two major funders of HIV programmes in the country which have made it possible for millions of HIV patients to receive standard antiretroviral therapy (ART) medication for free.
Standard care involves a tablet a day. For the injectable, however, a patient is given two injections every two months. The investigator meeting in Nairobi sought to provide insights on the treatment regime comparing this to what is happening in the rest of the world with the possibility of adjustments if need be.
Prof Reena Shah, the principal investigator at The Aga Khan University Hospital, said the injectable ARV will present patients with options.
“It is a bit like the female contraceptive, there are some women who like to take the tablets every day, others who prefer injections every few months and there are some who prefer the implants. It is the option for the patients,” she said.
This study is a follow-up to other studies done in high-income countries that led to the registration of the drug in those nations. Dr Kityo however noted that the data from those nations may not be applicable in the African context to facilitate registration of the same.