•Osoti is among the 87 Kenyans living with HIV who now receive a long-acting drug, given through two injections once every two months, to suppress HIV.
•She could not use her real name due to a confidential agreement she signed while joining the trial in June last year.
Having taken ARVs every single day for the last 20 years, Rose Osoti was surprised that nothing adverse happened when she ditched the pills in July last year.
In the beginning, she would often wake up at midnight frightened that something bad might happen. But one year later, HIV remains undetectable in her blood.
The recent count of her CD4 cells, the infection-fighting white blood cells that HIV normally destroys, showed they were plenty and within the normal range.
“I no longer have to remember to take pills,” Osoti says. “I'm also not taking Septrin (an antibiotic that fights opportunistic infections).”
She is among the 87 Kenyans living with HIV who are just completing one year of receiving a long-acting drug, given through two injections once every two months, to suppress HIV.
They no longer take the daily pills.
The injectable drug, called Cabenuva (a combination of cabotegravir and rilpivirine drugs), is not fully licenced in Kenya so the recipients only access it through a trial to test its delivery in local settings.
“I will mark one year in July this year,” Osoti, a trader in Kericho town, where she gets her injection at a public hospital said.
"I only got headaches a few days when I started last year. But they cleared and there are no other [side] effects."
She could not use her real name due to a confidential agreement she signed while joining the trial in June last year.
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 is acting as a control group for comparison.
The first Kenyan patient received the injections in March last year at the Aga Khan Hospital in Nairobi, followed by other patients in Kericho and Eldoret. The initial results are expected in September this year.
The Aga Khan site in Kenya has 40 patients, Kemri in Kericho has 67 and Ampath in Eldoret 67.
None of the patients has dropped out or experienced any adverse side effects, according to medics taking part in the trial.
But Osoti told The Star on Friday she fears what will happen once the trial is complete.
“The research will be for two years (until 2024) and I think after the two years they will follow up with us for another two years. I think those of us who took part in the research will be given the injection for life because they have already taken us off the pills,” she said.
“But I’m afraid if they stop giving us the drugs after trial. But wazungu cannot abandon us, or can they?”
She said they were only selected after rigorous tests and one had to be virally suppressed for at least four years.
“It was hard accepting the trial because I was hesitant, what if it backfires? But I was told there were other women ahead of me and there was no adverse reaction. But I have not met them to date,” Osoti, who is 55 years old said.
Female participants needed to commit not to fall pregnant during the trial because the drug’s effect on the foetus is not fully understood.
Participants are receiving two injections, one containing the Cabotegravir drug and the other Rilpivirine.
The shots are given on the same day once every two months.
Many of the study participants had been on daily ARVs pills for eight years and 57 per cent of them are women.
Experts monitor the participants’ viral loads every six months to determine if they are responding well to treatment.
In December last year, the Star spoke to researchers overseeing the trial in Uganda, Kenya and South Africa.
The World Health Organization in 2020 licenced 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 Cissy Kityo, a Ugandan epidemiologist who is overseeing the trial in the three countries said.
The overall aim 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.
“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 Rena Shah, a Kenyan infectious disease expert at the Aga Khan hospital who is leading the study at the hospital said.
Cabenuva is approved in the US, Canada, the European Union (under the brand names Vocabria and Rekambys), Australia and Switzerland among other countries.
In the US, a list price of $4,000 a month is given by the website drugs.com but costs vary depending on the treatment plan, costs of hospital visits and any negotiated discounts.
A recent study by University College London, the Bill & Melinda Gates Foundation and four other universities suggest any long-lasting ARV should cost no more than $131 (about Sh18,000) a year in sub-Saharan Africa in order to be cost-effective.
Currently, the cost of ARV pills for one year per patient in Kenya is slightly less than Sh20,000.
Osoti will complete one year under the injectable in July when she will go through more than 20 tests to check how the drug worked. “If my viral load will still be undetectable, this is the best thing ever,” she said.
“You see, I don’t worry about forgetting to take pills or about viral load. You are also given a five-day window period within which you can go for the injections, so it's good.”
(Edited by Tabnacha O)