Interim analysis from the HIV Prevention Trials Network (HPTN) 083 has been brought forward due to potential disruption that the COVID-19 pandemic may cause. Almost 4600 HIV-negative people across 40 sites in North and South America, Asia, and Africa were enrolled. Data reveals that long-acting injectable cabotegravir is safe and effective in preventing HIV among gay men and other men who have sex with men and transgender women.
In 2018, UNAIDS estimated that there were 1.7 million new HIV infections, 54% among key populations and their partners, including gay men and other men who have sex with men, transgender women, sex workers, people who inject drugs, people in prison, clients of sex workers, and sex partners of other key populations.
Pre-exposure prophylaxis (PrEP), is an important element in the HIV combination prevention toolkit.
Once cabotegravir receives regulatory approval, production can be scaled up and provide a choice of three effective PrEP methods to prevent HIV infection: daily pills, pills taken before or after sexual activity, or an injection every two months.
The World Health Organisation recommends that transgender women will be offered the injection or daily pills only, due to possible drug interactions with some hormones.
The Data and Safety Monitoring Board (DSMB) reviewed the data up to March 2020 and found clear evidence that cabotegravir was highly effective and not inferior to current PrEP regimens. Participants will be able to choose which regimen they wish to continue on.
An additional study - HTPN 084 - is ongoing in non-transgender African women, and results are expected in November.
Shannon Hader, UNAIDS Deputy Executive Director, Programme stated that, “We are particularly pleased that the study met its targets to recruit substantial numbers of younger black men who have sex with men and transgender women, the very people for whom accessing effective HIV prevention still remains a huge challenge.”