Gilead reports high efficacy in HIV and HBV treatment study

FOSTER CITY, Calif. - Gilead Sciences, Inc. (NASDAQ:GILD), a prominent player in the biotechnology industry with a market capitalization of $142.5 billion and annual revenue of $28.75 billion, recently showcased new data from its HIV treatment portfolio at the 2025 Conference on Retroviruses and Opportunistic Infections (CROI). According to InvestingPro analysis, the company maintains a "GREAT" financial health score, positioning it strongly in the competitive pharmaceutical landscape. The data included results from a Phase 3 study on Biktarvy’s efficacy in treating HIV and HBV co-infection, a Phase 2 study on a long-acting treatment regimen, and findings from the first HIV cure clinical trial conducted in South Africa.

The ALLIANCE trial, evaluating Biktarvy against a dolutegravir-based regimen in adults with HIV-1 and HBV co-infection, reported high rates of viral suppression after participants switched to Biktarvy following 96 weeks of treatment with the comparator regimen. At Week 48 of the open-label extension phase, 95.4% for HIV-1 and 86.6% for HBV virologic suppression was maintained. Adverse events were mostly mild to moderate, with weight gain and increased LDL cholesterol being the most common.

Additionally, Gilead’s investigational combination of lenacapavir (LEN) with broadly neutralizing antibodies (bNAbs), teropavimab and zinlirvimab, received Breakthrough Therapy Designation from the FDA in January 2025. This development comes as the company’s stock demonstrates strong momentum, with a 58.64% return over the past year and trading near its 52-week high of $119.96. For deeper insights into Gilead’s financial metrics and growth potential, investors can access comprehensive analysis through InvestingPro, which offers exclusive access to 16+ additional ProTips and detailed financial metrics. The LTZ regimen, designed for twice-yearly dosing, met its primary endpoint in a Phase 2 open-label study. At Week 26, 96% of participants maintained virologic suppression, with no serious adverse events related to the regimen reported.

In a landmark trial in South Africa, Gilead tested its investigational TLR7 agonist vesatolimod in combination with bNAbs in cisgender women with HIV. The study aimed to explore a potential HIV cure and demonstrated that 30% of participants remained off antiretroviral therapy through Week 48. No treatment-related serious adverse events were reported, although the regimen was not sufficient as an HIV cure.

Lenacapavir, approved in multiple countries for treatment-resistant HIV in combination with other antiretrovirals, is also being evaluated for HIV prevention. Biktarvy, combining bictegravir with emtricitabine and tenofovir alafenamide, is indicated for HIV-1 treatment in adults and pediatric patients with no treatment history or to replace their current regimen if virologically suppressed.

The use of Biktarvy in HIV/HBV co-infection, the combination of lenacapavir with bNAbs, and the investigational compounds teropavimab, zinlirvimab, and vesatolimod are not approved for any use by regulatory authorities, and their safety and efficacy have not been established.

This article is based on a press release statement from Gilead Sciences. While trading at a relatively high earnings multiple, InvestingPro data suggests the company maintains strong cash flows and operates with moderate debt levels. Investors seeking detailed analysis can access Gilead’s comprehensive Pro Research Report, part of InvestingPro’s coverage of 1,400+ US equities, offering actionable insights for informed investment decisions.

In other recent news, Gilead Sciences has reported significant advancements in its HIV prevention efforts with the investigational drug lenacapavir. The FDA has accepted Gilead’s New Drug Application for lenacapavir as a twice-yearly injectable for HIV prevention, granting it Priority Review status with a target action date set for June 19, 2025. This comes after promising results from Phase 3 trials, which demonstrated a substantial reduction in HIV infections with lenacapavir compared to oral alternatives. Meanwhile, Oppenheimer analysts have raised their price target for Gilead to $132, citing the potential of the cancer drug Trodelvy, especially in the treatment of triple-negative breast cancer. Morgan Stanley has also maintained its Overweight rating for Gilead, with a price target of $123, highlighting the projected sales growth for lenacapavir in the U.S. In a broader industry context, BTIG’s technical strategist noted that Gilead Sciences shows additional growth potential within the healthcare sector, which is currently leading the S&P 500. These developments underscore Gilead’s ongoing efforts in both HIV prevention and cancer treatment, positioning the company for potential growth in these areas.

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