66% increase in effectiveness! The latest results of a long-acting HIV prevention drug are released once every two months.

ViiV Healthcare announced on July 7th that injections of the long-acting drug cabottegravir (CAB) every two months were better than daily oral encourtabin/tenofovir fumarate tablets (FTC/TDF, 200mg/300mg, Truvada), based on data analyzed by the HIV Prevention Trial Network (HPTN) 083 study.
HPTN083 is a phase IIb/III randomized, multi-center, double-blind clinical trial designed to assess the safety and effectiveness of cabotegravir for pre-exposure hiv prevention (PrEP) in men who have sex with men (MSM) and transgender women who have sex with men.
The trial involved about 4,566 HIV-negative MSM and transgender women who had sex with men at research centers in Argentina, Brazil, Peru, the United States, South Africa, Thailand and Vietnam, who were considered to have an increased risk of HIV infection.
two-thirds of the participants were under the age of 30 (the middle age was 26) and 12 per cent were transgender women (n-567).
study participants were randomly assigned to two subgroups, group A took CAB tablets and TDF/FTC placebo tablets daily for 5 weeks, followed by two long-acting CAB intramuscular injections (4 and 8 weeks apart from oral drugs) and daily oral TDF/FTC before week 153.
B group took TDF/FTC and CAB daily for 5 weeks, followed by daily oral TDF/FTC and two intramuscular placebo injections in the following 4 and 8 weeks.
participants in Group A and Group B will take oral TDF/FTC daily from week 153 and continue for 48 weeks.
the study, participants were evaluated with 47 observations, including physical examination, blood collection, urine collection, electrostature and rectal swab collection.
the blinding phase of the study was discontinued in early May 2020 after a pre-planned review by the Independent Data and Security Monitoring Committee.
, the long-acting injection therapy cabottegravir is very effective in preventing HIV in the research population.
, 52 HIV cases were observed in the trial, 13 in the cabotegravir group and 39 in the FTC/TDF group.
this means that the incidence of HIV in the cabotegravir group is 0.41% (95% CI: 0.22%-0.69%), and in the FTC/TDF group it is 1.22% (95% CI: 0.87%-1.67%).
based on a random subset of 372 participants in the FTC/TDF group, the drug concentration in any detectable tynofovir was measured at 87% and the drug concentration in 75% of the test samples was consistent with the daily dose level ( sgt; 40 ng/ml), and the compliance of the daily oral FTC/TDF tablet was initially assessed to be high.
Despite the high compliance of oral drugs, long-acting injections of cabotegravir showed superiority in the main endpoints of HIV infection recorded - 66% (95% CI: 38%-82%) more effective than FTC/TDF in preventing HIV infection in the study population.
Throughout the study, long-acting injections of cabottegravir and FTC/TDF tablets were well toned, most adverse events were mild or moderate, and a balance was maintained between the two treatment groups.
reactions, fever and hypertension were more common in the cabottegravir group and nausea was more common in the FTC/TDF group.
of participants in the Cabotegravir group (80%) reported pain or pressure at the injection site, while only 31% in the FTC/TDF group reported this.
study, the suspension rate in the cabotegravir group due to injection site reactions or injection insatiability was 2.2%, which was not available in the FTC/TDF group.
Cabotegravir molecular structure Cabotegravir is a long-acting HIV-1 integrated enzyme chain transfer inhibitor with an aminomethyl pyridine structure similar to dolutegravir (dotegravir).
in its development and design, the drug has been packaged in nanoparticles (GSK744LAP) with a biological half-life of up to 21-50 days after administration.
theory, this makes it possible to use the drug in insinorifred every three months to suppress HIV.
the injectable drug is a single drug treatment or HIV prevention research new drug.
in addition to the HPTN083 study, a study on the safety and effectiveness of HIV prevention was conducted for active women, and more than 3,000 sexually active women from seven African countries have been included in the study.
reference source: ViiV Healthcare announces superior efficacy of investigational, long-acting injectable development of of cabotegravir dosed per two months over daily oral PrEP.