LOS ANGELES (May 20, 2020) - The AIDS Healthcare Foundation (AHF) today welcomed news shared by ViiV Healthcare (majority owned by GSK, with Pfizer Inc. and Shionogi Ltd. as shareholders), a drug company specializing in HIV medications, that a study it conducted shows that its long-acting, injectable HIV prevention medication cabotegravir (CAB LA) is 69% more effective than daily pills in preventing HIV acquisition in the patient protocol known as pre-exposure prophylaxis, or PrEP.
The company announced results of an interim analysis Sunday evening, also reporting that it would end the global study of its new HIV prevention medication early and offer all study participants access to CAB LA.
The remarkable efficacy of CAB LA resolves some of the AHF's earliest and sharpest criticisms of the original PrEP protocol: its total reliance on patient adherence to a daily pill regimen for its maximum preventive effect.
"We commend ViiV Healthcare for its tremendous breakthrough with cabotegravir and thank the company for suspending its study to make CAB LA readily available to all study participants," said Michael Wohlfeiler, MD, JD, chief of medicine, US, for the AHF. "As an injectable, two-month dosed medication that's demonstrated significantly greater efficacy than the current form of pre-exposure prophylaxis, cabotegravir offers an exciting way forward to far simpler and more effective HIV prevention."
ViiV's study cohort included 4,600 men who have sex with men (MSM) and transgender women who have sex with men in studies from over 40 sites around the globe. The study compared cabotegravir (CAB LA) injections administered every two months to the current standard of care, daily oral emtricitabine/tenofovir disoproxil fumarate 200 mg and 300 mg (FTC/TDF) tablets, an HIV/AIDS treatment medication manufactured by Gilead Sciences and branded as Truvada.
"From the very beginning of this debate, the AHF voiced significant concerns about PrEP's reliance on patient adherence to a daily pill regimen to achieve its preventive benefit," Michael Weinstein, president of AHF. "ViiV's remarkable study results here validate many of our earlier criticisms and concerns about PrEP. Cabotegravir looks to be an exciting new addition to the world of HIV prevention."
Since the FDA approved Gilead's Supplemental New Drug Application (sNDA) to market its AIDS treatment medication Truvada for use as PrEP on July 16, 2012, the AHF has repeatedly expressed concerns about the prevention protocol, particularly its reliance on patients' adherence to daily pill dosing.
"Were We Prepared for PrEP? Five Years of Implementation," an article co-authored by Michael Weinstein, AHF president; Otto Yang, MD, ScD, scientific director for the AHF; and Adam Carl Cohen, PhD, MPH, the AHF's director of advocacy and policy research, was published as a "Viewpoint" article in the October 4, 2017, edition of AIDS, an official journal of the International AIDS Society (IAS).
The article noted that the AHF, "...voiced concerns that PrEP would be difficult to implement because of healthcare barriers, have limited efficacy because of poor adherence, and increase risky sexual behaviors and transmission of other sexually transmitted infections. However, it also pointed out that the characterization that the AHF was "ardently anti-PrEP" was an "inaccurate oversimplification" of the AHF's position as the AHF recognized that "there is no doubt that PrEP is highly effective when taken correctly."
And in a January 2017 AHF press release headlined "AHF: NIH Finally Waking Up to Drawbacks of PrEP," the AHF expressed optimism at the news that the National Institutes for Health (NIH) were participating in the first-ever trials of an injectable, longer-acting form of pre-exposure prophylaxis - ViiV's cabotegravir. The AHF referenced a CNBC News article ("Single Shot at Doctor's Office May Be Future of HIV Prevention," Dec. 26, 2016), on the study, citing Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, who told CNBC: "The ultimate reason for the trial is that many people who take Truvada have difficulty with having to take a pill every single day...That really becomes prohibitive, and sometimes people don't adhere really well."
In the same press release, Weinstein stated "We have said since the beginning of this debate that an injectable or timed-release form of a medication to prevent HIV acquisition would be a superior option than relying so heavily on patient adherence to a daily pill regimen."
The AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to over 1.4 million people in 45 countries worldwide in the US, Africa, Latin America/the Caribbean, the Asia/Pacific region, and Eastern Europe. To learn more about the AHF, visit www.aidshealth.org or www.facebook.com/aidshealth and follow it on Twitter and Instagram: @aidshealthcare.
Courtesy of the AHF