Safety concerns have forced the Department of Health to delay its plans to provide HIV patients with dolutegravir, a cheaper and more tolerable alternative to one of the components currently used in the three-drug cocktail taken by most state patients.
The development is not only bad news for patients but also throws a spanner in the works of the state’s plans to increase the number of HIV patients on treatment from 3.9-million to over 6-million by 2020-21.
The department planned to provide patients with a generic fixed-dose combination pill containing tenofovir, lamivudine and dolutegravir in September, but was now unlikely to do so before next April, said Yogan Pillay, its deputy director-general.
Dolutegravir will replace efavirenz in the three-drug pill.
In May, the South African Health Products Regulatory Authority and medicine regulators in the US and Europe sounded a warning over dolutegravir, after a small study in Botswana reported birth defects among pregnant women who were taking the drug at the time of conception.
While no generic versions are yet registered, GlaxoSmithKline’s Tivicay and Trelavue are available in the private sector.
The South African Health Products Regulatory Authority issued a warning on May 22, advising doctors not to prescribe dolutegravir to women who were trying to fall pregnant.
It said women of child-bearing age who were taking dolutegravir should ensure they were using effective contraception. Those who were pregnant and taking the drug should not stop their therapy, but consult their doctor, it said.
The safety concerns had delayed the authority’s registration of generic three-in-one pills containing dolutegravir, but it would hopefully soon approve products from at least six manufacturers, said Pillay.
The AIDS drug tender, valued at R14bn when it was announced in January 2015, was scheduled to end in March but was extended to allow time for generic manufacturers to register fixed-dose combinations containing dolutegravir.
Pillay convened a meeting of experts last week to discuss how best to use dolutegravir in the light of the Botswana study, which included World Health Organisation representatives.
A decision has yet to be taken on dolutegravir.