Trials demonstrate superiority of “decisively” long-acting injectable PrEP

Every 8 weeks, the long-acting injection of the investigational drug cabotegravir provided better protection against HIV infection than the currently approved pre-exposure prophylaxis (PrEP), confirming the latest findings ..

Rafael Landwitz

Monica Gandhi

Data from the HIV Prevention Trial Network 083 Study (HPTN 083) show that participants who received injectable cabotegravir (ViiV Healthcare) took daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) It was 66% less likely to be infected with HIV than other participants.

HPTN 083 is a Phase 2b/3 randomized, multi-center, double-blind, double-dummy clinical trial in 43 centers across Africa, Asia, Latin America, and the United States, with more than 4,500 transgender women. I have registered a man (MSM) who has sex with a man. The blinded part of the study ended in May, as the Data Safety Oversight Board (DSMB) found that cabotegravir was “clearly shown” to be very effective in preventing HIV. ViiV Interim analysis of data..

Raphael J. Landovitz, MD, MSc, A medical professor at the University of California, Los Angeles Center for Clinical AIDS Research and Education presented updated data during the AIDS 2020 Virtual Meeting.

Landovitz found that the findings “definitively” established the superiority of “Cabotegravir” over FTC / TDF over HIV PrEP, but both regimens were safe and highly effective as HIV prevention tools. Said yes.

“Despite the striking effects of daily oral FTC/TDF to prevent HIV infection in various infection situations and populations, its public health impact does not provide uniform benefits to all populations.” Landwitz said during his presentation. “HIV is over-affected in the same population who has not found comparable access to oral tablet-based pre-exposure prophylaxis, compliance with intake, and persistence.”

“Incredibly important data”

Landovitz et al. reported a 1:1 ratio of either 5 weeks oral cabotegravir with cabotegravir and FTC/TDF placebo followed by intramuscular (IM) injections every 8 weeks for 148 weeks, or active FTC/TDF and placebo cabotegravir. Randomly assigned. ..

They have an HR of 1.22% (95% CI, 0.87-1.67) and 0.41% (95% CI, 0.22-0.69), and 0.34 (95% CI, 0.18-0.62) in favor of cabotegravir.

Landovitz and colleagues reported high adherence to FTC/TDF and both regimens were well tolerated. Due to injection site reactions, 46 participants discontinued injections into the active Cabotegravir arm.

“This is very important data,” he said. Monica Gandhi, MD, MPH, Professor of Medicine at the University of California, San Francisco, and Co-Chair of San Francisco at the conference. He was not involved in the study.

Landovitz will publish drug concentration and tolerance data in the future, helping to explain the “clinical implications of all these provocative findings and stimulating results” and the benefits of each regimen.

“It’s very exciting to have data that we can expect regulatory approval of additional PrEP agents to increase HIV prevention options,” said Landovitz.

Companion study

The companion trial HPTN 084 is currently evaluating injectable cabotegravir as an HIV PrEP in cis-gender women at high risk of HIV in seven African countries. ViiV said in May that DSMB also reviewed data from the trial and recommended that it proceed as planned.

“It’s important to have a complete dataset that includes cis- and trans-gender women and MSM.” Kimberly Smith, MD, MPH, The head of research and development at ViiV told Healio.

“We also aim to gain experience with Cabotegravir for prevention in other populations and geographic regions,” Smith said. We would also like to demonstrate the efficacy of Cabotegravir in those groups. “

Cabotegravir is already part of a long-acting injectable HIV treatment regimen. Approved in Canada But Not FDA..

perspective

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Paul A. Forberding, MD

This is certainly one of the most promising reports for AIDS 2020, demonstrating the potential for PrEP with the new long-acting integrase inhibitor cabotegravir. In the HPTN 083 trial, supported by the National Institute of Allergy and Infectious Diseases, non-HIV-infected MSM and transgender women were tested in a randomized group who received a current standard PrEP approach using a fixed-dose combination. In comparison, TDF and FTC were treated with IM cabotegravir injection every 8 weeks. About 5,000 people participated in the study, and the results show that both treatments were effective at lower rates of new HIV infection, while participants in the long-acting injection arm had very low rates. The risk of contracting treatment was significantly lower (only 2.2%). While these results were expected in the May pre-announcement, these data, based on a complete analysis, confirmed that these PrEP injections were effective and well tolerated. The data provide a better understanding of this important new option in HIV prevention, which promises to be a popular new direction in this crucial area.

Paul A. Forberding, MD

Infectious disease news editorial board

Professor of Medicine

AIDS Research Institute Director

University of California San Francisco

Disclosure: Volberding has not reported any relevant financial disclosures.

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