Three months after the United Kingdom and the United States approved a new injectable HIV treatment, Kenya administered the drug to its first patient.
On March 31, the unnamed patient became the first in Kenya to receive the antiretroviral therapy (ART) after being enrolled in a study by the Aga Khan University Hospital, Nairobi.
The drug is a combination of two other medications (Cabotegravir and Rilpivirine) and is administered as an injection once every two months for the treatment of HIV-1 infection in certain adults.
Since its discovery in the early 1980s, HIV treatment has been in use. Scientists have aimed at improving effectiveness by combining drugs, giving the world a three-drug course.
Life-saving treatment
But the current regimens (most HIV drug regimens consist of three different drugs taken orally daily) often result in side effects as well as pill burden from taking too many of them.
The Ministry of Health estimates that the number of people living with HIV that are on life-saving treatment has increased from 600,000 in 2013 to 1.2 million in 2021.
Subsequently, efforts have aimed at reducing the number of pills taken a day, the number of drugs in the combinations to reduce pill burden, and the side effects associated with the current ARTs.
“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,” said Prof Reena Shah, an infectious disease expert at the Aga Khan University Hospital and principal investigator of the study.
The fruits of this scientific labour were seen last year when the US approved the first injectable ART known as Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35 kilogrammes for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV. The jab is administered as an injection once every two months.
The UK also approved Cabotegravir with Rilpivirine, the injectable medication that requires an injection every other month, for patients, rather than the current regimen of taking pills daily.
The World Health Organisation (WHO) 2020, licensed a combination of the two ARVs as injectable given once every two months. However, studies that led to this licensing were mostly done in Europe, the Americas, and Asia, whose populations and socioeconomic backgrounds significantly differ from Africa.
Justifying why the study is being conducted in Africa, a statement by the Aga Khan read: “… the trial setting [in Europe, America, and Asia] was overly regulated, with intense laboratory testing, which is not the case in the public health sector in Africa. The findings, therefore, although positive, cannot be generalised to a public health setting in Africa.”
As a result, local researchers have set out to test the delivery of the injectable in an African health care system. The trial is being carried out at eight sites across Kenya, Uganda, and South Africa.
“This study is looking at using a different way of taking the HIV medicine; using injections of two medicines given once every two months,” said Prof Shah.
Kenya and Uganda each have three trial sites and there will be two in South Africa, with a total of 512 participants – 160 from Kenya, 202 from Uganda, and 150 from South Africa.
Drug donations
Other Kenyan centres are Kenyatta National Hospital (conducted by the United States Army Medical Research Directorate Kenya) and Ampath in Eldoret. The study is called the Cares (Cabotegravir and Rilpivirine: Efficacy and Safety Study). The study is funded by Janssen Emea with drug donations from both manufacturers of Cabotegravir ((Viiv/GSK) and Rilpivirine (Janssen).
Participants who are adults living with HIV and are already on treatment with the oral pills will be randomised to either continue their tablet ART or go onto the injection.
The researchers hope that the new injectable formulation will improve people’s lives because they will no longer have to swallow medicines every day or forget to take them altogether, therefore improving the success of the HIV treatment.
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