Investigational Long-Acting Injectable Cabotegravir Shows Superior Efficacy Over Daily Oral PrEP

ViiV Healthcare announced new data from the HIV Prevention Trials network (HPTN) 083 study at the 23rd International AIDS Conference (AIDS 2020) that demonstrated the superiority of investigational long-acting injectable formulation of cabotegravir compared with daily oral pre-exposure prophylaxis (PrEP) tablets in preventing HIV acquisition.¹

“This advancement has the potential to be a game-changer for HIV prevention, offering an option with very high rates of effectiveness and the convenience of reduced dosing from daily to just 6 times per year,” said Kimberly Smith, MD, MPH, and head of research and development at ViiV Healthcare. “We are thrilled with the results not only because of the high effectiveness of cabotegravir but also because this study adequately represents some of the populations most disproportionately impacted by HIV— black [men who have sex with men (MSM)] in the US, young MSM globally, and transgender women.”¹

The HPTN 083 study was a phase 2b/3 randomized, multicenter, double-blind, clinical trial that sought to evaluate the safety and effectiveness of cabotegravir when compared with daily oral emtricitabine/tenofovir disoproxil fumarate 200 mg and 300 mg (FTC/TDF) tablets normally used in HIV prevention. Fifty two total documented cases of HIV were observed, with 13 being treated with long-acting cabotegravir and 39 with daily oral FTC/TDF.¹

The study consisted of HIV-negative men and transgender women who have sex with men, all of whom were considered at higher risk for HIV. Two-thirds were under the age of 30, with a median age of 26, and 12% of the total were transgender women, whereas half were identified as Black or African American.¹

Though there were higher levels of adherence to oral therapy, based on data from 87% of the participants that detected levels of tenofovir, long-acting cabotegravir nevertheless translated lower HIV incidence rates. The cabotegravir group achieved a 0.41% rate of infection, compared with 1.22% in the FTC/TDF group.¹

Consequently, in terms of effectiveness, cabotegravir was 66% more effective than FTC/TDF tablets were in preventing HIV in the study population.¹

Although both treatments were well-tolerated during the study, reactions to the injection site, including pain or tenderness, was mentioned by 80% of participants in the cabotegravir group. Other reactions included pyrexia and hypertension. Nausea was more common in the FTC/TDF group. There was a 2.2% rate of discontinuation of cabotegravir injection due to this, and no discontinuations in the FTC/TDF group.¹

An additional study is being conducted in sexually active women, as part of the HIV Prevention Trials Network 084, with more than 3000 sexually active women across 7 African countries presently enrolled.¹

Cabotegravir has yet to be approved by regulatory authorities, but many are hopeful. “Medicines that help prevent new HIV incidence are essential to our ongoing global fight to end the HIV epidemic,” said Myron S. Cohen, MD, co-principal investigator of the HPTN and the Yeargan-Bate distinguished professor of medicine, microbiology and immunology and epidemiology at the University of North Carolina at Chapel Hill.

“It’s exciting to discover that with injectable, long-acting cabotegravir, we now have compelling clinical evidence of another effective PrEP option that could play a critical role in helping to reduce HIV transmission that will ultimately save lives,” Cohen said. ¹

References

1. ViiV Healthcare Announces Superior Efficacy of Investigational, Long-Acting Injectable Formulation of Cabotegravir Dosed Every Two Months Over Daily oral PrEP. News Release. Businesswire; July 7, 2020. Accessed July 8, 2020. https://www.businesswire.com/news/home/20200707005511/en/ViiV-Healthcare-Announces-Superior-Efficacy-Investigational-Long-Acting