Cabotegravir (CAB LA), administered by injection every two months, was shown to be 69% more effective than daily pills in preventing HIV acquisition
CAB-LA’s formulation—and efficacy—resolve one of AHF’s earliest and sharpest criticisms of the prior PrEP protocol: its total reliance on patient adherence to a daily pill regimen for maximum preventive effect
LOS ANGELES (May 20, 2020) AIDS Healthcare Foundation (AHF) today welcomed news shared by ViiV Healthcare (majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders), a drug company specializing in HIV medications, that a study it conducted shows 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 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 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, 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, 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 AHF and Adam Carl Cohen, PhD, MPH, 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 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 AHF was “ardently anti-PrEP” was an “inaccurate oversimplification” of AHF’s position as AHF recognized, “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,”
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. 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, Fauci said. “That really becomes prohibitive and sometimes people don’t adhere really well.”
In the same press release, AHF President Michael 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.”