Game-Changing HIV Prevention Drug Raises Concerns Over Access in Crucial Regions

A groundbreaking new injectable medication, lenacapavir, offers the potential to revolutionize HIV prevention. Clinical trials demonstrated a perfect success rate in protecting young women in South Africa and Uganda, while also proving highly effective in diverse populations across Latin America, Asia,the United States, and Africa.

However, a recent agreement between the drug manufacturer, Gilead, and six generic manufacturers is sparking controversy. While it allows for increased production and availability in 120 low- and middle-income countries struggling with high HIV incidence, it excludes key regions experiencing alarming rises in new infections.

“This is the closest we’ve ever come to an HIV vaccine," says Andrew Hill, MD, PhD, a senior visiting fellow at the University of Liverpool, "but it will be incredibly difficult for people at risk to access lenacapavir at affordable prices in many countries where HIV is spreading fastest."

Rising Infections in Eastern Europe and Central Asia Raise Alarm

The exclusion of key regions like Eastern Europe and Central Asia (EECA), where new infections are surging, is particularly concerning. New HIV cases in EECA have increased by a staggering 20% between 2010 and 2023, combined with a disturbing 34% rise in deaths. While the war in Ukraine contributes to this troubling trend, unsafe drug injecting practices and widespread discrimination against key populations, particularly men who have sex with men, play prominent roles.

While a subset of countries within EECA is included in the Gilead agreement, they are not prioritized for Gilead-supplied drugs until generic production ramps up. Several countries with high HIV prevalence, including Russia, Serbia, and Bulgaria, have been completely excluded, despite clearly demonstrable need.

Adding to the urgency, recent reports by the World Health Organization (WHO) indicate rising diagnoses in Western and Northern European countries like Ireland, Iceland, Finland, Malta, and Montenegro, reflecting a worrying expansion of the epidemic. These regions, also largely excluded from the agreement, are grappling with surging case numbers

Funding Gap Persists, Political Will Lags

The EECA region faces a dual funding challenge. Domestic budgets are constricted by competing priorities while their classification as upper-middle or high-income automatically excludes them from crucial international funding institutions like the Global Fund.

"Countries who are unable to purchase generic lenacapavir, and don’t qualify for Global Fund aid, face two options: paying the full price, which Gilead has yet to publicize, or potentially pursuing a compulsory license to override intellectual property protections," observes Debra ten Brink, MD, MPH, from the Burnet Institute. "This underscores the problematic dilemma of access to crucial medications based on economic status, not public health."

Miłosz Parczewski, MD, PhD, President-Elect of the European AIDS Clinical Society, attributes the challenges

to a pervasive “political stigma” – a lack of full commitment to tackling the HIV epidemic.

"This manifests in inadequate perception of the epidemic, limited public awareness, ongoing economic hardship, and migration," he says. "Expanding prevention programs, including access to PrEP, is urgently needed.

Andriy Klepikov, PhD, executive director of the Alliance for Public Health in Ukraine, emphasizes the dire situation nationwide. "Lenacapavir is a game-changing medication. In Ukraine, it’s desperately needed, and we eagerly await its availability."

The Urgent Need for a Global Response

The limited access to lenacapavir threatens to widen the gap in HIV care and potentially delay the end of the AIDS epidemic. The promise of a highly effective preventative measure should be made available to all, regardless of geographical location or economic status. Addressing this issue demands a unified global response, with a focus on affordable access, increased funding, and decisive political action.