In a major breakthrough in the fight against new HIV transmissions, a British pharmaceutical company has announced that PrEP injections every two months have proven more effective than a once-daily pill.
GlaxoSmithKline (GSK) said its injectable antiretroviral cabotegravir was so effective at preventing transmission of HIV that clinical trials were stopped early, and those taking the twice-daily pill were offered bimonthly injections instead.
The current standard for PrEP — or pre-exposure prophylaxis — is the once-daily antiretroviral combination of emtricitabine/tenofovir, manufactured by Gilead Sciences under the brand name Truvada.
Taken regularly, Truvada is around 99% effective at preventing transmission of HIV during sexual intercourse between an HIV-negative person and someone living with the virus.
But GSK said that its clinical trial demonstrated that an injection of cabotegravir every two months was 69% more effective at preventing transmission of HIV compared with Truvada.
The clinical trial, HIV Prevention Trials Network (HPTN) 083, was conducted by ViiV Healthcare and involved 4,600 HIV-negative cisgender men and transgender women who have sex with men in North and South America, Asia, and Africa.
Of those participants, 38 who were taking the daily pill became infected with HIV, while only 12 who received injections every two months became infected.
GSK reported that most (80%) of the participants receiving the injection reported pain or tenderness at the injection site, but only 2% of participants discontinued due to that discomfort or reaction to the injection.
An interim review by the Data and Safety Monitoring Board, an independent organization, found that the bimonthly injections were “highly effective at preventing HIV in the study population,” GSK reported.
“These study results demonstrate that long-acting injectable cabotegravir dosed every two months can successfully reduce HIV acquisition in at-risk MSM and transgender women,” said Kimberly Smith, M.D., Head of Research & Development at ViiV Healthcare.
“We are thrilled with the results,” Smith continued, “not only because of the high efficacy of cabotegravir but also because we have demonstrated high efficacy in a study that adequately represents some of the populations most disproportionately impacted by HIV — black MSM in the U.S., young MSM globally and transgender women.”
Myron S. Cohen, M.D., Co-Principal Investigator of the HPTN and Professor of Medicine, Microbiology and Immunology and Epidemiology at the University of North Carolina (UNC) at Chapel Hill, noted that around 1.7 million people are newly diagnosed with HIV each year.
“To lower that number, we believe more prevention options are needed in addition to currently available oral tablets for daily use,” Cohen said. “If approved, a new injectable agent, such as long-acting cabotegravir administered every two months, could play an important role in reducing HIV transmission and helping to end the HIV epidemic.”
PrEP has already proven to be an effective tool in preventing HIV transmission, with the Australian state of New South Wales attributing a record drop in new HIV infections to the increased availability of the drug.
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