The national Health Department has been forced to postpone a nationwide rollout of the latest blockbuster HIV treatment amid persistent concerns about what may be a low risk of birth defects linked to the drug’s use, reports Bhekisisa. This is despite the World Health Organisation (WHO) green-lighting the drug for use globally in July.
The medication, known as dolutegravir, was set to be introduced in September as part of a new three-in-one pill that would combine the relatively new antiretroviral (ARV) with two more commonly used ARVs, tenofovir and emtricitabine.
Bhekisisa says most South Africans on HIV treatment already use these two drugs alongside a third called efavirenz. But a 2019 research review by the WHO found that dolutegravir was better than efavirenz at dropping the level of HIV in people’s blood down to very low levels – also known as being virally suppressed. It was also more forgiving of skipped doses, reducing patients’ risk of developing drug resistance.
The WHO’s decision to recommend the drug for use globally was informed in part by South African research. But, Bhekisisa says, it also found that participants on dolutegravir were more likely to pick up weight than those on other drugs – about 5 kgs after a year. There are also still lingering concerns about what could be a very small risk of serious birth defects, called neural tubal defects, linked to conceiving while on the drug. The condition affects the brain, spine or spinal cord.
Bhekisisa reports that in South Africa, concerns around this prompted the National Health Council’s decision to delay dolutegravir’s rollout. At an August meeting, the body requested more information about the possible risk of birth defects and weight gain. The group also wanted more details about cost-benefit analyses done regarding the drug.
Bhekisisa says an August health department circular says that although the country will “ceremonially launch” the dolutegravir on World Aids Day in December, a three-drug combo containing the wonder ARV won’t be in patients’ hands until January at the earliest.
Meanwhile, Bhekisisa says, provincial depots have been instructed to stop delivering the medication to clinics. But, it says, the health department is confident it will have enough efavirenz-based treatment to carry the country over until it can begin switching patients who have been on treatment for six months or more, and who are virally suppressed, onto the newer drug.
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