The United Nations Joint Program on HIV / AIDS (UNAIDS) leads the global effort to defeat the human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS) as a threat to public health by 2030.
Since the first HIV cases were reported in the 1980s, 78 million people have been infected with the virus, while 35 million have died from AIDS-related diseases.
UNAIDS was strongly encouraged by the new results of innovative studies showing that the antiretroviral drug cabotegravir given by injection every two months – prevents HIV among women.
Four HIV infections occurred among the women randomly assigned to the injectable cabotegravir arm of the study, compared with 34 infections in the arm that was randomly assigned to daily oral PrEP. HIV risk was nine times lower with cabotegravir injections than with daily oral PrEP. Above, a prepared syringe (3 ml) of cabotegravir. Photo credit: HPTN 084 study website
The HPTN study
The study, called the HIV Prevention Trials Network study (HPTN 084), evaluates the safety and efficacy of the long-acting injectable antiretroviral drug cabotegravir (CAB LA) for pre-exposure prophylaxis (PrEP) in women without HIV infection.
The study showed that the drug appeared to have prevented HIV infection in healthy women and, as a result, the Data and Safety Monitoring Board (DSMB) stopped the study early.
In the study, 3,223 women between the ages of 18 and 45 who were at risk of contracting HIV infection were enrolled. Participants came from 20 sites in seven sub-Saharan African countries, including Kenya, Malawi, Botswana, eSwatini, South Africa, Zimbabwe and Uganda.
Participants were divided into two arms: Arm A, which received CAB LA as an intramuscular injection every eight weeks, and tenofovir / emtricitabine daily oral placebo (TDF / FTC) and arm B, which received daily oral TDF / FTC and CAB intramuscular LA placebo every eight weeks.
Results of the study
The researchers found that 38 women in the study acquired HIV infection. Four were randomized to the long-acting cabotegravir arm and 34 were in the daily oral FTC / TDF arm. This means that in the cabotegravir group, the HIV accident rate was 0.21%, compared to the FTC / TDF group, which had an HIV accident rate of 1.79%.
The study results show that cabotegravir is significantly more effective at preventing HIV infection than oral PrEP, which has long been used as an HIV prophylaxis. Furthermore, the results are important and timely as more methods to prevent HIV among women at higher risk of HIV are badly needed, especially methods that do not require daily pills, abstinence from sex and use. condom.
“These results are extremely significant. UNAIDS has long been calling for more, acceptable and effective HIV prevention options for women, and this could be a real game changer, “said Winnie Byanyima, UNAIDS Executive Director.
“If donors and countries invest in introducing access to injectable PrEP for women at increased risk of HIV, new infections could be drastically reduced,” he added.
In eastern and southern Africa, the HIV infection rate is high; this is especially true among women. More effective and affordable HIV prevention methods for women are essential. While the use of daily prophylaxis pills is very effective in preventing HIV in women, some find it difficult to take a daily tablet or pill. As a result, they often forget or become inconsistent with the dosage needed to provide adequate protection.
A long-acting injectable drug can help improve HIV prevention without depending on individual compliance with a daily oral PrEP regimen. It also offers a better alternative for women who don’t want to take a daily tablet.
Is the drug available?
Currently, women who started using CAB LA during the study will continue to receive it until the original duration of the study ends. However, before CAB LA becomes publicly available, regulators will need to review the study results. From there, if the results are convincing, the production and distribution of the drug will begin.
UNAIDS congratulates everyone involved in this landmark study. As with a COVID-19 vaccine, we now need to work to ensure that these life-changing injections are accessible, affordable, and fairly distributed to the people who choose to use them, ”Ms. Byanyima said.