South African drugmaker Aspen Pharmacare on Monday launched a triple-combination tablet for the treatment of HIV in the country where the virus is most prevalent.
The company's new Emdolten drug is a once-a-day tablet in the form of dolotegravir, an antiretroviral drug that counteracts the drug resistance that often develops with older HIV treatments, Aspen said.
The drug also contains lamivudine and tenofovir disoproxil fumarate alongside dolutegravir.
In May, the South African Health Regulatory Authority and the European Medicines Agency issued a warning advising doctors not to prescribe dolotegravir to women seeking to become pregnant.
This was followed by preliminary data from a study in Botswana, which found four cases of neural tube defects in babies born to mothers who became pregnant while taking the drug.
Tivicay and Triumeq, which are sold by GlaxoSmithKline's majority-owned ViiV Healthcare Unit.
Aspen, who pioneered the development and production of generic antiretrovirals (ARV) in South Africa, said that using dolutegravir was safe for men, women who are not of child-bearing age and child-bearing women using contraceptives, adding that these groups represent more 70% of HIV patients.
"The fact that it has been registered means that SAHPRA is comfortable that it is safe to take to the public," said Stavros Nicolaou, an Aspen strategic trade executive, told Reuters, referring to the South African Health Products Regulatory Authority.
The company launched Aspen Stavudine – its first generic ARV drug in August 2003 – at a time when the country was grappling with a high rate of HIV infection.
South Africa has 19% of the world's number of people living with HIV, 15% of new infections and 11% of AIDS-related deaths, the United Nations AIDS Agency says on its website.
There is no vaccine to prevent HIV / AIDS. Current treatments only help patients to manage the disease, but the fast-mutating virus has proven to be a challenge to the medical community because it often develops resistance to existing medicines.