The new Emdolten remedy is a disposable tablet in the form of an ARV drug that damages the resistance to drugs that often develop with older HIV treatments.
Aspen Pharmacare logo. Picture: delivered.
JOHANNESBURG – South African drug maker Aspen Pharmacare launched on Monday a triple combination tablet for the treatment of HIV in a country where the virus is most common.
The new Emdolten remedy is a disposable tablet in the form of dolutegravir, an antiretroviral drug that damages the resistance to drugs that often develop with older HIV treatments, Aspen said.
This medicine also contains lamivudine and tenofovir disoproxil fumarate together with dolutegravir.
In May, the South African Health Office and the European Medicines Agency issued a warning to doctors not to prescribe dolutegravir for women who want to get pregnant.
This was followed by preliminary data from a study in Botswana, which revealed four cases of neural tube defects in babies born to mothers who became pregnant with taking the drug.
The drug is found in branded medicines Tivicay and Triumeq, which sell GlaxoSmithKline in the majority-owned ViiV Healthcare unit.
Aspen, a pioneer in the development and manufacture of generic antiretroviral (ARV) drugs in South Africa, said that the use of dutegravers is safe for men, women who have no age, and women using the child for contraception, adding that these groups account for more than 70% patients with HIV.
"The fact that it is registered (Emdolten) means that SAHPRA is comfortable to be safe for the public," Aspen's Executive Director Stavros Nicolaou told Reuters, referring to the South African Health Regulatory Authority.
The company launched Aspen Stavudin – its first generic ARV drug in August 2003 – at a time when the country is struggling with a high rate of HIV infection.
South Africa has 19% of the global number of people living with HIV, 15% of new infections and 11% of AIDS-related deaths, according to a United Nations agency website.
There is no vaccine against HIV / AIDS. Current treatments only help patients control the disease, but a rapidly changing virus has proven to be a challenge to the medical community as it often develops resistance to existing drugs.