Long-Acting PreP is a Necessity, Not a Luxury: ViiV’s Greed is Still Blocking Global Access to Injection that Could Transform HIV Prevention and Help End the Pandemic 

In response to ViiV’s announcement today that it is working with the Medicines Patent Pool “to outline a positive path forward for voluntary licensing of long-acting HIV prevention,” Health GAP released the following statement:

“ViiV’s statement today with the Medicines Patent Pool on long-acting cabotegravir (CAB-LA) is most notable for what the company refuses to say. ViiV must stop dragging its feet and announce an incontrovertible commitment to issuing voluntary licenses as a corporate priority, along with an interim global access price for low, middle-, and upper-middle-income countries (LMICs) that is comparable with generic oral PrEP. Otherwise, HIV prevention apartheid will intensify as a truly game-changing tool will be kept out of the hands of people most in need,” said Asia Russell, Executive Director. “ViiV should commit now to entering into a voluntary license to allow for generic production and sales in all low- and middle-income countries and to accelerating regulatory approval and WHO pre-qualification. Why should we give ViiV credit for intention when they hold all the power to actually do these things but have refused to, up to today? Statements and intentions don’t save lives and prevent new infections, access does. ViiV should save their ink for when they have something of substance to announce.”

Activists are demanding ViiV:

1. Commit to voluntary licensing that will cover all LMICs and will include comprehensive technology transfer, on a stated timeline that matches the urgency of this moment to deploy this game-changing drug to countries with the largest HIV epidemics;

2. Price CAB-LA for PrEP comparable to oral PrEP while ViiV is the sole source of CAB-LA;

3. Stop the secrecy – instead of inexcusable nondisclosure requirements, commit to transparency and public communication regarding all aspects of its access strategy; and

4. Pledge publicly that scientific research regarding how best to deliver CAB-LA will not precede or impede development of a voluntary licensing agreement. Implementation science must not be used as a smokescreen to delay negotiation over voluntary licensing and announcement of an access price.

Context:
Long-acting injectable cabotegravir (CAB-LA) was approved on December 20, 2021 by the U.S. FDA for HIV pre-exposure prophylaxis (PrEP). While daily oral PrEP regimens are safe and effective, research has found that CAB-LA, taken every two months, is superior to oral PrEP for HIV prevention, including among transgender women, cisgender adolescent girls and women, gay men and other men who have sex with men—populations that are made extremely vulnerable to HIV infection because of discrimination, criminalization, and marginalization. Adherence to a daily oral PrEP regimen is a persistent obstacle undermining the effectiveness of oral PrEP as an HIV prevention tool particularly for adolescent girls and young women in sub-Saharan Africa. 5,000 new HIV infections occur weekly among women and girls aged 15-24 years. These studies suggest that CAB-LA has the potential to be a game-changing advancement in ending the HIV pandemic so long as the drug is accessible.

ViiV itself is shaping up to be the biggest barrier to global access to CAB-LA, especially for women and girls and key populations in low- and middle-income countries who arguably stand to benefit the most from this advancement. By pricing CAB-LA far out of reach for people in most low-income countries, ViiV is on track to repeat avoidable access barriers that put oral PrEP access in sub-Saharan Africa a decade behind the global north, that have generated COVID-19 vaccine and treatment apartheid, and that started with deadly inequities in HIV treatment in the global South. ViiV has refused to announce a public price outside the U.S., although in a private virtual meeting on March 7, ViiV stated that their lowest not-for-profit price would be between $240-270 per patient per year, despite the fact that experts say it can be produced for $20 per person per year. ViiV has announced it is pricing CAB-LA at approximately $23,000 per person per year in the United States. Dramatic interventions are required to ensure this massive scientific advancement is available to the people who stand to benefit the most from accessing it.

Key moments:

• December 20, 2021 – FDA approves CAB-LA, the first injectable for HIV pre-exposure prophylaxis
• March 4, 2022 – ViiV announces it will not pursue voluntary licensing for CAB-LA to allow generic manufacturing and accessible pricing for low- and middle-income countries
• March 4, 2022 – Under intense pressure from civil society groups, ViiV reverses its position and announces it is “open to” voluntary licensing to enable greater access to CAB-LA in low- and middle-income countries
• March 7, 2022 – ViiV in a private meeting shares that their lowest not-for-profit price would be between $240-270 per patient per year, effectively pricing out most people in low-income countries
• April 4, 2022 – ViiV and the Medicines Patent Pool release a statement saying they are “working … to outline a positive path forward” for voluntary licensing while also alleging several barriers in manufacturing and implementation would slow access in low- and middle-income countries. This premise, for which there is no evidence, would give ViiV cover to drag their feet and preserve their sole-source status, instead of doing what is needed: signaling immediately to generic manufacturers that voluntary licensing is a priority–not something to which they are paying lip service.
• During the period since U.S. FDA approval alone, 427,400 people worldwide became HIV positive. In sub-Saharan Africa, 6 out of 7 new HIV infections among adolescents were girls and young women aged 15-19.

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