One new biannual injection for pre-exposure prophylaxis (PrEP) was 96% effective in reducing infections caused by HIV according to a clinical study published last Thursday (27) in The New England Journal of Medicine (NEJM). The research was phase 3, which evaluates the effectiveness and safety of a new medical treatment in a large number of people.
The work, called Purpose-2is the second to confirm the high efficacy of lenacapavir to prevent HIV infection. In July this year, the Purpose-1 clinical trial, carried out in three locations in Uganda and 25 regions in South Africa, showed 100% efficacy in cisgender women.
Lenacapavir is a biannual injectable medication developed by the pharmaceutical company Gilead Sciences. It acts as a capsid fusion inhibitor, which means it interferes with the HIV capsid, a protein coat that protects the virus’s genetic material and the enzymes needed for replication. Its use is injectable, under the skin, requiring application only twice a year — once every six months.
How was the study carried out?
In Purpose-2, biannual lenacapavir was tested in a more diverse audience. While the first work only analyzed cisgender women in regions of Africa, the most recent study involved participants of different genders, including cis men and trans people, as well as more ethnicities, being conducted in 88 research centers in Peru, Brazil, Argentina, Mexico , South Africa, Thailand and the United States.
The study looked at the safety and effectiveness of twice-yearly lenacapavir for PrEP compared to Truvada, a daily pill that has been widely used for more than a decade as PrEP.
In total, the work involved 3,271 gay, bisexual and other cisgender men, transgender women and men, and non-binary people aged 16 and over who have sex with partners assigned male at birth.
Participants were randomly assigned in a 2:1 ratio to receive lenacapavir and Truvada, respectively. Because effective PrEP options already exist, there is broad consensus that a placebo group would be unethical; therefore, the trial used bHIV as the primary comparator and Truvada as a secondary comparator.
According to the study, lenacapavir was highly effective in reducing HIV infections among study participants: 99.9% of participants did not acquire HIV in the lenacapavir group, with two incident cases among 2,179 participants.
The trial data confirm that both participants acquired HIV after receiving their first lenacapavir injections but before their second injections, and both participants were diagnosed using standard HIV tests.
The results also demonstrated the superiority of biannual lenacapavir over bHIV with a relative risk reduction of 96%. Additionally, the shot given twice a year was 89% more effective in reducing HIV infections than Truvada given once a day.
Also according to the study, there were nine incident cases of HIV among the 1,086 individuals in the Truvada group. These nine participants had evidence of low or no adherence to Truvada, or had discontinued use more than 10 days before diagnosis.
To date, lenacapavir is approved in several countries for the treatment of adults with multidrug-resistant HIV in combination with other antivirals. The use of the injection to prevent HIV remains in the study phase and has not yet been approved as PrEP by regulatory agencies.
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This content was originally published in HIV: biannual injection reduced risk of infection by 96% in new study on the CNN Brasil website.
Source: CNN Brasil
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