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Cabotegravir Injectable Long Acting PrEP Study HPTN-083 Stopped Due To Higher Efficacy
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Global HIV prevention study to stop early after ViiV Healthcare's long-acting injectable formulation of cabotegravir dosed every two months shows higher efficacy than daily oral PrEP - (05/18/20)
• Interim analysis from HPTN 083 study shows investigational, long-acting injectable cabotegravir (CAB LA) administered every two months is 69% more effective than daily pills in preventing HIV acquisition
• Participants who were in the daily oral emtricitabine/tenofovir disoproxil fumarate 200 mg and 300 mg (FTC/TDF) tabletarm of the study will be offered CAB LA
HPTN 083 media briefing May 18 2020 archived: recorded call can be found here: https://www.wevideo.com/view/1714219824
http://natap.org/2020/HIV/052220_01.htm
In the study cabotegravir was found to be 69% more effective (95% CI 41%-84%) in preventing HIV acquisition in men who have sex with men (MSM) and transgender women who have sex with men when compared to the current standard of care, daily oral emtricitabine/tenofovir disoproxil fumarate 200 mg and 300 mg (FTC/TDF) tablets. The study achieved its primary objective of non-inferiority with the difference approaching superiority in favour of cabotegravir, pending final analysis.
- Adherence to oral FTC/TDF was high, based on a random subset sampling that detected tenofovir (> 0.31 ng/ml) in 87% of all samples tested. Despite this high level of adherence to oral therapy, long-acting cabotegravir was 69% (95% CI 41%-84%) more effective than FTC/TDF in preventing HIV acquisition in the study population.
- Among the 50 people in the trial who acquired HIV, 12 were randomised to the long-acting cabotegravir arm and 38 were randomised to the daily, oral FTC/TDF arm. This translated to an HIV incidence rate of 0.38% (95% confidence interval [CI] 0.20%-0.66%) in the cabotegravir group and 1.21% (95% CI 0.86%-1.66%) in the FTC/TDF group.
- said Kimberly Smith, M.D., Head of Research & Development at ViiV Healthcare. "We are thrilled with the results 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 US, young MSM globally and transgender women,”
- 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.
Long-acting injectable drug prevents HIV infections - (05/18/20) Science Mag, Jon Cohen
Landovitz says ViiV is planning for "global scale up" of the injections and to have them accessible in low-resource settings.
So why did a dozen people who got shots of the drug still get infected? "One of our most pressing analytic tasks at this point is to examine these 12 cases of HIV that were acquired after being exposed to cabotegravir," says Landovitz. A person's weight could be an explanation. Earlier studies have shown that men and transgender women (who are born male) with a lower body mass index more rapidly eliminate the drug from their blood. Another possibility is those who got infections did so very early in the study. Because of safety concerns about cabotegravir, the study required people in the injection group to first take pills of the drug for 5 weeks; the infected participants may have failed to takes some of those doses during that period. Or someone could have been infected with an HIV variant that is resistant to cabotegravir.
- It's unclear whether injected cabotegravir will work in other populations. HPTN 084, a sister study, is staging the same comparison in heterosexual women and could have clear data as early as November. As for HPTN 083, a close examination of infections in penetrative partners, instead of receptive partners, may clarify whether the injections are likely to work in heterosexual men. Long-acting cabotegravir has shown promise as a treatment, too, but has yet to receive regulatory approval. Other long-acting anti-HIV PrEP treatments are in the works, too. Landovitz says ViiV is planning for "global scale up" of the injections and to have them accessible in low-resource settings, but nothing has been made public about pricing.
Long-acting injectable cabotegravir is highly effective for the prevention of HIV infection in cisgender men and transgender women who have sex with men - (05/18/20) HPTN Statement
Based on the recommendation by the DSMB, the blinded, randomized portion of the study will end. All participants will be informed of these results as soon as possible and will be told which study medication they received. Participants who were in the TDF/FTC arm will be offered CAB LA when it becomes available. Participants in the CAB LA arm will continue to receive it. Participants who do not want to receive CAB LA will be offered TDF/FTC.
"Until we have a safe and effective vaccine for HIV, we must continue to find innovative prevention strategies," said Myron Cohen, M.D., HPTN co-principal investigator and director of the Institute for Global Health at the University of North Carolina in Chapel Hill. "Increasing the number of effective tools will give people who want to prevent HIV an opportunity to find a method that works for them."
"Demonstrating conclusively that long-acting injectable cabotegravir is highly effective almost two years earlier than originally expected is exciting news," said HPTN 083 protocol chair Raphael J. Landovitz, M.D., M.Sc. "It is inspiring that we may soon have additional HIV prevention options for at-risk individuals who have difficulty with or prefer not to take pills.
"A long-acting injectable for PrEP that does not require adherence to an oral daily pill is a great addition to the HIV prevention toolbox," said HPTN 083 protocol co-chair Beatriz Grinsztejn, M.D., Ph.D. "Prevention strategies have never been one-size-fits-all." Dr. Grinsztejn directs the Instituto de Pesquisa Clinica Evandro Chagas HIV/AIDS Clinical Research Centre of the Oswaldo Cruz Foundation-Fiocruz in Rio de Janeiro, Brazil.
A companion study that began a year after, HPTN 084, is comparing the efficacy and safety of CAB LA to daily oral TDF/FTC for PrEP among women in sub-Saharan Africa. This study, which began approximately a year after HPTN 083, was also reviewed by the DSMB and was recommended to continue as planned. "The findings from HPTN 083 are an important milestone along the path towards ending the HIV epidemic," said Wafaa El-Sadr, M.D., M.P.H., HPTN co-principal investigator, director of ICAP and professor of epidemiology and medicine at Columbia University in New York. "We look forward to the results from HPTN 084, a critically important sister study among women at risk for HIV in sub-Saharan Africa."
The HPTN 083 study is jointly funded by NIAID and ViiV Healthcare. Study product is provided by ViiV Healthcare and Gilead Sciences, Inc.
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