The much-anticipated antiretroviral (ARV) dolutegravir will be introduced as the first-line treatment for the HIV infected in South Africa as early as April, Health Department deputy director-general Dr Yogan Pillay said at the 9th International Aids Society (IAS) conference on HIV Science in Paris this week.
A dolutegravir-based regimen will be a “game-changer” for South Africa and people living with HIV because it has fewer side-effects and is cheaper than existing treatments, according to Professor Francois Venter from the Wits Reproductive Health and HIV Institute.
Initially planned to enter the South African market in October next year, Pillay said that the timing would depend on when suppliers register the fixed-dose-combination (FDC) version with the Medicines Control Council.
“During this conference, I’ve been meeting all the suppliers to find out when they will register. We think that definitely two, most likely three, will register this year and if they register we can start earlier,” he said.
ARV therapy requires taking three drugs a day, every day, for life, but treatment is made easier when all the drugs are combined into one pill – an FDC.
He said that current treatment based on the drug efavirenz had side-effects that can be severe and make the medication difficult to take for patients. These included mental health and liver problems.
Dolutegravir’s side-effects are milder and much less common and could make taking treatment for life much easier.
According to a January paper published in the South African Medical Journal, a dolutegravir-based regimen could translate into initial cost-savings of 20% of the country’s annual ARV budget. When volumes are met, when the majority of patients have been switched to the regimen, cost savings could reach 50%.
Venter said this was largely due to the price of the raw materials used to manufacture the drug. The cost savings are highly significant as South Africa runs the largest ARV programme in the world and spends roughly R10 billion a year on procuring the medicines for local patients. Dolutegravir could also solve the country’s ARV-resistance problem, said Venter.
He said reports indicated that at least 10% of patients on treatment had developed resistance to first-line ARVs.
HIV-drug resistance occurs when individuals do not take their medicines as prescribed.
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