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GSK: ViiV Healthcare HIV Prevention Study Shows Higher Efficacy

GlaxoSmithKline plc (GSK,GSK.L) announced Monday that its majority-owned specialist HIV company ViiV Healthcare, with Pfizer Inc. and Shionogi Limited as shareholders, will stop its HIV prevention study with cabotegravir early following higher efficacy results.

The company announced the interim analysis of the HIV Prevention Trials Network or HPTN 083 study evaluating the safety and efficacy of investigational, long-acting, injectable cabotegravir for HIV prevention. The HPTN 083 study, with approximately 4,600 participants in North and South America, Asia, and Africa, is one of the first-ever clinical trials to directly compare two active prevention agents.

The HPTN 083 study enrolled HIV-negative men who have sex with men and transgender women who have sex with men, participants considered at risk for HIV acquisition.

In the trial, cabotegravir dosed every two months was found to be 69% more effective in preventing HIV acquisition than the current standard of care, daily oral emtricitabine/tenofovir disoproxil fumarate 200 mg and 300 mg tablets.

The study achieved its primary objective of non-inferiority with the difference approaching superiority in favour of cabotegravir, pending final analysis.

Following review of these findings, the Data and Safety Monitoring Board or DSMB recommended the blinded, randomised portion of the study be stopped early and results released.

Detailed results from HPTN 083 will be presented at an upcoming scientific meeting.

ViiV Healthcare plans to use the data from HPTN 083 for future regulatory submissions. Cabotegravir has not yet been approved for the treatment or prevention of HIV as a single agent by regulatory authorities anywhere in the world.

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