Gilead to 'redefine' HIV PrEP market with 2025 Sunlenca launch

Gilead Sciences, well-known for its focus on oncology and advancements in the HIV treatment space, is making significant strides in the field of HIV prevention with its drug Sunlenca (lenacapavir). The drug, which received FDA approval for treating multidrug-resistant HIV, was introduced at the end of 2022. Despite its promising potential, Sunlenca currently requires combination with other daily medications to form a complete regimen, limiting its use to a niche segment—about 2% of adults with HIV.

Gilead’s vice president of clinical development, Jared Baeten, M.D., Ph.D., described the initial approval as merely “the beginning of the rest of this journey.” The company is now setting its sights on launching Sunlenca as a long-acting pre-exposure prophylaxis (PrEP) medication by 2025. The anticipated move aims to revolutionize the PrEP market by offering a twice-yearly dosing schedule, promising convenience and potentially greater compliance among users.

In a significant milestone, Sunlenca demonstrated perfect efficacy in a phase 3 trial for PrEP among cisgender women, with no infections reported in the study involving more than 2,000 participants. The next steps involve ongoing studies in other populations, including cisgender gay men, transgender women and men, and nonbinary individuals. These populations present varied levels of PrEP awareness and compliance, which Gilead’s chief commercial officer Johanna Mercier acknowledged as a key challenge.

Mercier emphasized the unique nature of the PrEP market, where patients are generally healthy and the need for daily medication adherence poses a significant hurdle. She highlighted the potential of lenacapavir to offer a new approach to HIV prevention and make a substantial impact on the HIV epidemic.

Currently, Gilead maintains a strong presence in the PrEP market with Descovy, a follow-on therapy to Truvada. However, Sunlenca offers a transformative opportunity to reshape the market. While GSK was the first to introduce a long-acting PrEP medication with Apretude, which is administered every two months, Sunlenca stands out for its six-month dosing schedule. GSK is also working on four- and six-month dosing options, expected to launch later this decade.

Financially, Gilead’s HIV segment remains a robust contributor, generating $4.7 billion in sales during the second quarter. Leading the charge is Biktarvy, which alone brought in $3.2 billion and holds over 49% of the U.S. HIV treatment market, marking a consistent increase in market share.

In oncology, Gilead is banking on Trodelvy’s success as a second-line treatment for metastatic triple-negative breast cancer despite facing clinical setbacks in other cancer types such as non-small cell lung cancer and bladder cancer. The company is conducting a phase 3 trial to explore Trodelvy’s potential in earlier lines of treatment for triple-negative breast cancer, a move that could pave the way for global regulatory filings.

Overall, Gilead reported a 5% increase in total sales for the second quarter, amounting to $7 billion. This growth reflects the company’s diverse portfolio, encompassing HIV treatments, liver disease therapies, and oncology products.