JOHANESBURG (Reuters) – South African drugmaker Aspen Pharmacare on Monday released a triple-combination tablet for HIV treatment in the country where the virus is most prevalent.
The company's new drug Emdolten is a once-a-day tablet in the form of dolutegravir, an anti-retroviral drug that counteracts drug resistance that often develops with older treatments, Aspen said.
The drug also contains lamivudine and tenofovir disoproxil fumarate alongside dolutegravir.
In May, the Health Products Regulatory Authority of South Africa and the European Medicines Agency issued an alert warning doctors not to prescribe dolutegravir to women wishing to become pregnant.
That followed preliminary data from a study in Botswana that found four cases of neural tube defects in babies born to mothers who became pregnant while taking the medicine.
The drug is found in medicines brand Tivicay and Triumeq, sold by the ViiV Healthcare health unit, majority owned by GlaxoSmithKline.
Aspen, a pioneer in the development and manufacture of generic antiretrovirals (ARVs) in South Africa, said dolutegravir is safe for men, women of no age and women with contraceptives, adding that these groups represent more than 70 percent of HIV patients.
"The fact that (Emdolten) was registered means that SAHPRA is comfortable in taking it to the public," Aspen strategic trade executive Stavros Nicolaou told Reuters, referring to the Health Products Regulatory Authority of South Africa.
The company launched Aspen Stavudine – its first generic ARV drug in August 2003 – at a time when the country was experiencing a high rate of HIV infection.
South Africa has 19 percent of the global number of people living with HIV, 15 percent of new infections and 11 percent of AIDS-related deaths, the UN agency said on its website.
There is no vaccine to prevent HIV / AIDS. Current treatments only help patients manage the disease, but the fast mutant virus has proved a challenge for the medical community because it often develops resistance to existing drugs. (Reporting by Nqobile Dludla, editing by James Macharia and David Goodman)