The Kenyans are part of 512 Africans taking part in a trial to test how well the treatment works in Africans living with HIV.
A total of 174 Kenyans are taking part in the trial, and half of them are no longer taking the daily pills. The other half are acting as a control group for comparison.
The treatment has been proven to work well in Europe and in the United States, where it is already approved.
Patients only need two injections given on the same day, once every two months.
The team conducting the trial in Kenya told the Star it already looks promising.
“We are moving on well that’s why the independent data monitoring committee gave us the go-ahead to continue,” Dr Cissy Kityo, a Ugandan epidemiologist and medical researcher who is overseeing the trial in Kenya, Uganda and South Africa, said.
The first Kenyan patient received the injections in March this year at the Aga Khan Hospital in Nairobi, and the initial results are expected in September next year.
None of the patients has dropped out or experienced any adverse side effects.
“We have recruited 512 participants. The study is moving smoothly and we have already held three meetings where presentations show the drug is safe for the patients,” she said.
There are three trial sites in Uganda, and two in South Africa; the Aga Khan site in Kenya has 40 patients, Kemri in Kericho has 67 and Ampath in Eldoret 67.
Participants are receiving two injections, one containing the Cabotegravir drug and the other Rilpivirine.
The injections are given on the same day once every two months.
The World Health Organization in 2020 licensed the two injectable ARVs because studies done in Europe, Americas and Asia showed they are as good as the daily pills.
“But these studies were done among males in those regions and here [in Africa] it's mostly women who are affected. The HIV subtype here is also different. Our disease environment is also different and we have more pregnancies. So it was necessary to repeat those studies here to generate guidelines for WHO,” Dr Kityo said.
The trial, which began in 2019 in Uganda, is called Cabotegravir And Rilpivirine: Efficacy and Safety (Cares) Study and is funded by Janssen Pharmaceuticals, which produces rilpivirine. US pharma ViiV Healthcare produces cabotegravir.
Many of the study participants have been on daily ARVs pills for eight years and 57 per cent of all the participants are women.
“Successful treatment of HIV leads to control of viral multiplication. This success relies on people taking their drugs regularly. The way someone takes their drugs may depend on several factors that include the number of drugs taken, the ease of swallowing them, the number of times they are taken, their taste, as well as the associated side effects among other factors,” Prof Rena Shah, a Kenyan infectious disease expert at the Aga Khan hospital who is leading the study at the hospital, said.
Currently, most HIV drug regimens consist of three different drugs that need to be taken orally daily.
“This study is looking at using a different way of taking the HIV medicine; using injections of two medicines given once every two months. These injected medicines have worked well in previous studies done in the USA, Europe and South Africa, but have not yet been evaluated in the rest of Africa,” Prof Reena said.
It is thought that taking medicine by injection will improve people’s lives because they no longer have to swallow medicines every day.
It is also expected to deal with the risk of forgetting to swallow pills and may improve the success of the HIV treatment.
The overall aim of the study is to demonstrate that switching from taking daily ART pills to injectable long-acting drug will not reduce the effectiveness of the ART on participants.
This will mean that the viral control will be maintained, and the side effects will not be more and the general livelihood of the patient will not be affected.
Participants will continue on their normal ART as a single tablet or fixed-dose combination regimen as per local country guidelines for up to 24 months.
Experts are monitoring the participants’ viral loads every six months to determine if they are responding well to treatment.
