Gilead's Yeztugo Poised to Reshape HIV Prevention Market, GSK Prepares Counteroffensive

Gilead Sciences is set to transform the HIV prevention landscape with its newly approved twice-yearly drug Yeztugo, as the company aims to solidify its dominance in the HIV market. Meanwhile, GSK is gearing up to defend its market share, setting the stage for an intense competition in the pre-exposure prophylaxis (PrEP) sector.

Yeztugo's Potential Market Impact

Gilead's Yeztugo, a long-acting HIV prevention drug administered twice a year, has received regulatory approval and is projected to achieve peak sales of approximately $4.5 billion. The company's CEO, Daniel O'Day, outlined a three-pronged strategy to capture market share:

1. Convert the existing 400,000 to 450,000 U.S. PrEP users to Yeztugo
2. Target the 750,000 to 800,000 individuals who could benefit from PrEP but are not currently using preventive medication
3. Expand into international markets, emphasizing Yeztugo's value proposition to payers and health ministries

Gilead expects Yeztugo to have 70% to 75% payer coverage within six months of launch, increasing to 90% by the end of its first year on the market. The company believes that Yeztugo could significantly improve treatment compliance, which currently stands at around 50% for daily oral PrEP regimens.

GSK's Competitive Response

GSK, through its HIV joint venture ViiV Healthcare, is preparing to defend its position in the PrEP market. The company's Apretude, an injectable preventive administered every two months, saw sales increase by approximately 90% last year, reaching £279 million ($383 million).

David Redfern, ViiV Chairman, expressed confidence in Apretude's continued growth, stating, "We certainly expect Apretude to continue to grow this year." He argued that the PrEP market remains "significantly underdeveloped" and that the introduction of Yeztugo could help expand the market for all players.

GSK is also advancing its pipeline to challenge Gilead's dominance in both HIV treatment and prevention:

• VH184: An integrase strand transfer inhibitor with a reportedly superior resistance profile
• N6LS: A broadly neutralizing antibody
• VH499: A capsid inhibitor

The company aims to launch a twice-yearly HIV treatment and PrEP drug between 2028 and 2030, directly competing with Gilead's Yeztugo regimen.

Market Dynamics and Future Outlook

The total HIV market is valued at approximately £22 billion ($30.2 billion), with treatments accounting for 90% of sales. Gilead's Biktarvy currently holds a 51% share of the U.S. treatment market, while its Descovy maintains over 40% market share in the PrEP sector.

As the competition intensifies, both Gilead and GSK are investing heavily in their pipelines. Gilead has 12 clinical programs in HIV, including a potential once-yearly version of Yeztugo's active ingredient. The coming years are likely to see continued innovation and market reshaping as these pharmaceutical giants vie for dominance in the evolving HIV prevention and treatment landscape.