66% increase in the effectiveness of hiv pre-exposure prevention! Cabotegravir is eligible for breakthrough therapy

On November 17, ViiV Healthcare announced that the FDA has awarded its long-acting integrated enzyme inhibitor Cabottegravir breakthrough therapy for pre-exposure HIV prevention (PrEP).
FDA findings are based on the efficacy and safety results of a randomized, multi-center, double-blind, IIb/III clinical study code-named HPTN 083.
the findings were presented at the 23rd International AIDS Congress (AIDS 2020) in July this year.
083 study included about 4,566 transgender female subjects who were gay and had sex with men.
the subjects were HIV-negative, but were considered at risk of HIV infection, with two-thirds under the age of 30 and 12 percent transgender women.
study aims to assess the effectiveness of cabotegravir injections every 2 months (8 weeks) and 1 oral injection per day for pre-exposure HIV prevention (FTC /TDF, Truvada, 200 mg/300 mg).
the study was opened in November 2016 at research centers in Argentina, Target, Peru, the United States, South Africa, Thailand, and Vietnam, where subjects received up to three years of treatment under blind law.
analysis showed that one Cabottegravir injection in two months was 66 percent more effective at HIV prevention than one oral Truvada tablet a day.
of the 52 subjects who had HIV infection, 13 were from the Cabogravir group, with an HIV infection rate of 0.41% (95% CI:0.20%-0.66%) and 39 from the Truvada group with an infection rate of 1.22% (95% CI:0.86%-1.66%).
Cabotegravir's effectiveness in preventing HIV infection increased by 66 percent over Truvada's, and an HIV prevention study for sub-Saharan African women codenate HPTN 084 was terminated earlier this month on the recommendation of the Independent Data Security Monitoring Board (DSMB) because of Cabodegravir's effective oral Truvada tablets for HIV infection prevention.
ViiV Healthcare plans to submit Cabotegravir's listing application in the future based on data from two HPTN studies.
, MD, ViiV Healthcare Research and Development, said: "New drugs to reduce the risk of HIV infection among at-risk populations are an important tool to help us end the global HIV epidemic.
data from HPTN 083 and 084 studies show that long-acting cabottegravir is superior to daily oral FTC/TDF tablets in HIV prevention.
look forward to working closely with the FDA to provide this prevention option for people at risk of HIV infection.
" HIV remains a global public health crisis, with an estimated 38 million people living with HIV and 1.7 million new HIV cases by the end of 2019.
in research and development have identified new approaches to HIV treatment and prevention, such as the long-term role of cabottegravir.