/ 23 December 2021

FDA approval of injectable HIV prevention drug an important milestone for sub-Saharan Africa

South Africa has the largest HIV epidemic in the world with 6.8-million people infected with the virus. Reuters

The approval of the first ever long-acting HIV prevention injection by the US Food and Drug Administration (FDA) has been lauded as a positive step towards preventing infections with the virus among women and adolescent girls.

Known as CAB-LA, the cabotegravir injectable drug will be given to individuals as a pre-exposure prophylaxis every two months.

The FDA’s approval of the drug was based on data from two studies that were conducted by the HIV Prevention Trials Network (HPTN) in May and November 2020.

Both the HPTN 083 study –  among cisgender men and transgender women who have sex with men – and the HPTN 084 study – conducted on cisgender women – showed that when administered as an injection every eight weeks, CAB-LA was superior to daily oral tenofovir/emtricitabine for HIV prevention. It was also well-tolerated in both studies.

Currently, pre-exposure prophylaxis is only available in a daily pill form in South Africa.

“The  approval of the injectable cabotegravir for HIV prevention by the US FDA is a tremendous milestone  for the HIV prevention field and adds another option for HIV prevention,” Sinead Delany-Moretlwe, a research professor at the University of Witwatersrand and director of the Wits Reproductive Health Institute, said in a press statement.

Delany-Moretlwe led the HPTN 084 trial, which enrolled 3 223 cisgender women at research sites in Botswana, Eswatini, Kenya, Malawi, South Africa, Uganda, and Zimbabwe. 

Specialist in HIV treatment manufacturing VIIV Healthcare will market CAB-LA under the name Apretude and has already applied for approval to regulatory authorities in South Africa, Malawi, Botswana and Zimbabwe. 

“While the FDA announcement is exciting, we are really looking forward to approvals from the regulatory authorities in the African region. We believe that injectable PrEP (pre-exposure prophylaxis) could significantly impact the trajectory of HIV in our region,” Delany-Moretlwe said.

UNAids estimated that 37.7-million people worldwide were living with HIV in 2020 and 1.5-million people were newly infected in the same year, with women and girls accounting for 50% of the new infections. As of June this year, 28.2-million people living with the virus were accessing antiretroviral therapy.

In South Africa, an estimated 7.7-million people were living with HIV in 2019 with a prevalence of 20.4% in the general population. In sub-Saharan Africa, South Africa is the only country that offers pre-exposure prophylaxis to populations that are vulnerable to HIV.