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The South African drug maker Aspen Pharmacare launched Monday a triple combination tablet for the treatment of HIV in the country where the virus is most prevalent.
The company's new drug Emdolten is a once-daily tablet in the form of dolutegravir, an antiretroviral drug that counteracts the drug resistance that often develops with older anti-HIV treatments, said Aspen.
The drug also contains lamivudine and tenofovir disoproxil fumarate as well as dolutegravir.
In May, the South African Health Products Regulatory Authority and the European Medicines Agency warned doctors not to prescribe dolutegravir to women wishing to become pregnant.
This follows preliminary data from a study conducted in Botswana, which revealed four cases of neural tube defects in infants born to pregnant mothers while taking the drug.
The drug is found in Tivicay and Triumeq branded drugs sold by GlaxoSmithKline's ViiV Healthcare unit.
Aspen, a pioneer in the development and manufacture of generic antiretrovirals (ARVs) in South Africa, said the use of dolutegravir was safe for men, women under the age of childbearing and women using contraceptives, more than 70% of HIV patients.
"The fact that she (Emdolten) has been registered means that SAHPRA is of the opinion that it is safe to talk to the public," Stavros Nicolaou, head of Aspen's strategic trade, told Reuters the South African Health Products Regulatory Authority.
The company launched Aspen Stavudine – its first generic antiretroviral – in August 2003 – at a time when the country was struggling with a high rate of HIV infection.
South Africa accounts for 19% of the total number of people living with HIV, 15% of new infections and 11% of AIDS-related deaths, according to the UN Agency on AIDS on its website .
There is no vaccine to prevent HIV / AIDS. Current treatments only help patients manage the disease, but the fast-changing virus has proved a challenge for the medical community as it often develops resistance to existing medications.
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