Cipla's new triple combination ARV approved in South Africa

The South African Health Products Regulatory Authority (SAHPRA) has approved Cipla’s latest first-line triple-combination antiretroviral (ARV) treatment for HIV. The new combination medicine, commonly referred to as TLD, is a combination of tenofovir (TDF), lamivudine (3TC) and dolutegravir (DTG).

In future, TLD will be manufactured at Cipla’s facilities in Durban and Uganda, reinforcing Cipla’s commitment to produce medicines in Africa for Africa and ensuring more affordable treatment for patients.

Head of Manufacturing for Cipla South Africa, Mr. Ajay Kumar Pal, said the reason for the new formulation complexity related to the three different processes required for the three APIs. In addition to the considerable technology and infrastructure investment of more than Rand 48-mn (including a machine worth Rand 16-mn), there are additional complexities pertaining to the double coating and compression of the tablet, and need for exhaustive testing at different stages of manufacturing.

Local manufacture

Cipla’s investment in infrastructure aligns with the South African government’s request to support local industries to stimulate economic growth. Manufacturing and investment in infrastructure have been identified by the World Bank, and in the United Nations Sustainable Development Goals, as the multiplier for job creation, economic growth and development in any country. “Cipla continues to work closely with government in this regard and to ensure that people have access to affordable treatment,” the company said in a statement.

Cipla has a legacy of pioneering affordable ARVs. In 2001, it produced the world-first three-in-one fixed combination drug, available at less than $1 per day.

“We’re always focused on ensuring patients benefit by having access to quality, affordable ARVs. DTG is considered a best-in-class medicine providing many clinical benefits for people living with HIV. With DTG replacing efavirenz (EFV) in the first-line fixed dose combination treatment thereby reducing the likelihood of treatment failure, TLD has the potential to reduce overall treatment costs,” Cipla South Africa CEO, Mr. Paul Miller, said. According to UNAIDS, “antiretroviral therapy using dolutegravir has several advantages over other regimens, including clinical superiority, improved side-effect profile, and reduced risk of viral resistance.”