RESEARCH TRIANGLE PARK – An injectable drug from ViiV Healthcare has proved to be much more effective in preventing HIV among women than a currently daily pill treatment, ViiV announced early Monday.

And a doctor at UNC-Chapel Hill who is co-investigator in the project hailed the results for the drug which is called cabotegravir. Earlier this year the drug was reported as being effective in prevention of HIV among men.

The drug is injected six times a year. Truvada, the pill regime which is the only pre-exposure prophylaxis, or PrEP for women, requires daily dosing. The news about effectiveness in women comes months after similar effectivess was reported by ViiV among men.

Some 38 million people wordwlide have HIV with 1.7 million new cases and more than 600,000 deaths reported in 2019, according to HIV.gov statistics. Nearly half  new HIV infections in adults globally were among women last year, amfAR, The Foundation for AIDS Research, reported. Approximately 19 percent, or 7,000, of new HIV cases in the United States in 2018 were women, Centers for Disease Control show.

UNC-CH photo

Myron Cohen, MD

“With the combined landmark findings of HPTN 084 [women] announced today and HPTN 083 [men]announced earlier this year, we’ve confirmed that long-acting cabotegravir is a superior HIV prevention option for men and women,” said Dr. Myron Cohen, the Yeargan-Bate Distinguished Professor of Medicine, Microbiology and Immunology and Epidemiology at UNC.

“New HIV prevention agents that address the many needs of all individuals at risk for acquiring HIV are essential pillars of our strategy to end the HIV epidemic. If approved, this innovative new injectable option administered once every two months will expand the way we approach HIV prevention.”

Others praised the news.

“It’s a game changer for women,” Dr. Sigal Yawetz, an expert on women with H.I.V. at Brigham and Women’s Hospital in Boston who was not involved in the trial, told the New York Times.

Viiv announced that an an independent data safety monitoring board analysis “indicated that cabotegravir met the primary objective of demonstrating superiority when compared to the current standard of care for women, daily oral emtricitabine/tenofovir disoproxil fumarate 200 mg and 300 mg tablets. The study showed cabotegravir was 89% more effective than daily oral [pills] for pre-exposure prophylaxis (PrEP).”

Kimberly Smith, head of Research & Development at ViiV Healthcare, sees multiple benefits from the drug. She called the results “ground breaking.”

“Women need more effective choices for HIV prevention,” she said in a statement. “If approved, long-acting cabotegravir will provide an option that reduces the number of annual dosing days from 365 to six. In addition, long-acting cabotegravir can be discretely administered and may empower women to reduce their risk of HIV acquisition without the need for negotiation with their sexual partner. The results of HPTN 084 confirm long-acting cabotegravir’s potential as an HIV prevention option that can meet these needs.”

ViiV maintains a significant R&D center in RTP. Its majority owner is GlaxoSmithKline.

You can read the full announcement online.

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