JOINT MEDIA RELEASE
Johannesburg - 22 December 2021
On Monday, the U.S. Food and Drug Administration (FDA) announced their approval of the long-acting injectable cabotegravir (CAB-LA) as the first long-acting injection for use as a pre-exposure prophylaxis. Pre-exposure prophylaxis or PrEP involves taking an antiretroviral to prevent HIV infection. In South Africa, PrEP is only available as a daily pill currently. The FDA was based on data from two studies conducted by the HIV Prevention Trials Network (HPTN). In May and November 2020, these studies showed that CAB-LA administered as an injection every eight weeks was superior to daily oral tenofovir/emtricitabine (TDF/FTC) for HIV prevention among cisgender men and transgender women who have sex with men (HPTN 083) and cisgender women (HPTN 084). Both studies also demonstrated that CAB-LA was well-tolerated, offering a new and important pre-exposure prophylaxis (PrEP) option for individuals at risk for HIV infection.
Data from the HPTN studies HPTN 083 and HPTN 084 helped provide important information which influenced the decision by the FDA to approve ViiV Healthcare’s long-acting CAB-LA injections for the prevention of HIV. These trials were sponsored and co-funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). ViiV Healthcare will market CAB-LA for PrEP under the brand name ‘Apretude’.
HPTN 083 enrolled 4,570 cisgender men and transgender women who have sex with men at research sites in Argentina, Brazil, Peru, South Africa, Thailand, the U.S., and Vietnam. In the study, 52 HIV infections occurred, with 12 new infections in the CAB arm and 39 new infections in the TDF/FTC arm. These findings translate to a 69 percent reduction in incident HIV infections in study participants given CAB-LA compared to TDF/FTC.
HPTN 084 enrolled 3,223 cisgender women at research sites in Botswana, Eswatini, Kenya, Malawi, South Africa, Uganda, and Zimbabwe. There were three new infections in the CAB arm and 36 new infections in the TDF/FTC arm, a 92 percent reduction in incident HIV infections in study participants given CAB-LA compared to TDF/FTC.
The trial, known as the HPTN 084 trial was led by Prof Sinead Delany-Moretlwe, a research professor at the University of the Witwatersrand and Director of Research at Wits RHI, 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,” says HPTN 084 protocol chair Delany-Moretlwe. ‘’The recommendation is important because it is inclusive of all populations including adolescents who are at high risk for HIV infection. It’s also an important signal to other drug regulatory authorities particularly in the African region. A strong FDA recommendation may support in-country reviews and recommendations.”
ViiV have also submitted to regulatory authorities in South Africa, Malawi, Botswana and Zimbabwe. While CAB-LA will only be available in the USA for now but will pave the way for approval in other countries, including South Africa.
“These results are incredibly important for us in Sub-Saharan Africa where two thirds of new HIV infection occur in women, particularly adolescent women. We believe that the injectable PrEP offers people a discreet and convenient alternative to daily oral pills for HIV prevention. 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 could significantly impact the trajectory of HIV in our region,” Delany-Moretlwe explains.
“These results are a milestone for prevention of HIV among women at risk of HIV worldwide and especially for women in sub–Saharan Africa. If we are to turn the tide on the HIV epidemic, we will need prevention options that work for women in sub-Saharan Africa. These findings provide great hope and motivation for additional studies to show safety an acceptability in adolescents, pregnant and breastfeeding women,” Professor Helen Rees, Executive Director of Wits RHI, said in November last year.
CAB-LA is a much-needed addition to a proven HIV prevention options that now also includes male and female condoms, daily oral PrEP (pills), voluntary medical male circumcision (VMMC) and the Dapivirine Vaginal Ring.
HPTN 083 was co-funded by NIAID and ViiV Healthcare. HPTN 084 was co-funded by NIAID, the Bill & Melinda Gates Foundation, and ViiV Healthcare. Study product was provided by ViiV Healthcare and Gilead Sciences, Inc. Three other NIH institutes also collaborated on HPTN 083 and HPTN 084: the National Institute of Mental Health, the National Institute on Drug Abuse, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
The HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network that brings together investigators, ethicists, community members and other partners to develop and test the safety and efficacy of interventions designed to prevent the acquisition and transmission of HIV. NIAID, NIMH, Office of The Director, and NIDA, all part of NIH, co-fund the HPTN. The HPTN has collaborated with more than 85 clinical research sites in 19 countries to evaluate new HIV prevention interventions and strategies in populations that bear a disproportionate burden of infection. The HPTN research agenda – more than 50 trials ongoing or completed with over 161,000 participants enrolled and evaluated – is focused primarily on the use of integrated strategies: use of antiretroviral drugs (antiretroviral therapy and pre-exposure prophylaxis); interventions for substance abuse, particularly injection drug use; behavioural risk reduction interventions and structural interventions.
Link to sound bite by Professor Sinead Delany-Moretlwe (Director of Research: Wits RHI): https://cutt.ly/HUu3BLf
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About Wits RHI
Wits Reproductive Health and HIV Institute (Wits RHI) celebrates 27 years of an unparalleled track record of conducting world class research, implementing sustainable programmes, and contributing to health policy. Wits RHI is part of the Faculty of Health Sciences and the largest research institute of the University of the Witwatersrand. We are a UNAIDS, WHO and South African Medical Research Council (MRC) collaborating centre as well as a United Nations Population Fund (UNFPA) strategic partner.
Over the years we have been involved in innovative research and increasing outputs in our key focus areas which include Sexual Reproductive Health (SRH) & HIV, and Vaccine and Infectious Diseases and Other Emerging Issues. However, we have expanded our portfolio to urbanisation, non-communicable diseases, and climate change. The Institute is continuously embracing research, programmatic support, training, policy development, health systems strengthening and technical assistance at a national and international level. This allows Wits RHI’s scientific agenda to be responsive to emerging challenges in the environments in which we work, while simultaneously encouraging our senior research and programmatic staff to innovate and implement new ideas.
We aim to deliver excellent science and innovation, that impacts on priority public health problems within the African region and develops human capital. We forge local, regional and global partnerships to support this agenda and create an environment that attracts, develops and retains skilled and talented personnel, who share our passion for better health in Africa.
HIV Prevention Trials Network
U.S. Food and Drug Administration (FDA)I
FDA Approves First Injectable Treatment for HIV Pre-Exposure Prevention | FDA