Bulevirtide Acetate

The launch of Gilead’s groundbreaking HIV prevention shot is progressing “well ahead of our expectations,” the company’s chief commercial officer said Thursday. Yeztugo, the first-ever twice-yearly prevention shot available in the US, was approved in June for pre-exposure prophylaxis (PrEP) in adults and adolescents. The first prescription was written hours after the approval, and the first injection was administered within days, Gilead chief commercial officer Johanna Mercier told investors on the company’s second-quarter earnings call. “The team has been executing what I consider to be the best-planned commercial launch I have seen to date,” she said, adding later that Gilead “hit the ground running.” Yeztugo is also known as lenacapavir, which was first approved by the FDA in 2022 as Sunlenca for the treatment of HIV. Other options for prevention include ViiV Healthcare’s shot Apretude, which is administered every two months, or daily pills for PrEP. In an effort to differentiate Yeztugo, Gilead has positioned the injection as a more convenient option that could drive stronger patient adherence. The company declined to provide exact figures on the number of Yeztugo prescriptions written or the number of doses administered so far. But Mercier said on the call that Gilead is “extremely pleased with the feedback from both clinicians and consumers, as well as the progress of our early discussions with payers.” Gilead’s HIV product sales increased 7% in the second quarter, compared to the same period in 2024, reaching $5.1 billion. That includes a 35% sales spike for Descovy, a tablet that can be used for HIV prevention and in combination with other medicines to treat the virus. Biktarvy, Gilead’s other oral treatment for HIV, saw a 9% sales increase. The company now expects HIV sales to grow about 3% in 2025, as opposed to prior expectations of flat year-over-year revenue, partly driven by strong sales of Biktarvy and Descovy. CFO Andrew Dickinson said Gilead isn’t updating its assumptions for Yeztugo revenue in the second half of 2025 “at this time,” despite being “very encouraged by the launch dynamics” so far. Gilead raised its full-year sales guidance to $28.3 billion to $28.7 billion, slightly up from prior expectations of $28.2 billion to $28.6 billion. That takes into account lowered expectations for the company’s Covid-19 antiviral Veklury, as the company reports lower rates of Covid-related hospitalizations. Elsewhere in its news release, Gilead reported a $190 million impairment charge related to assets from its $1.7 billion acquisition of MYR in 2020. Hepcludex, MYR’s hepatitis delta virus treatment approved in Europe, was at the center of the buyout. However, the FDA rejected the drug in 2022 over “manufacture and delivery” concerns, Gilead said at the time. It now has a biologics license application pending, according to Gilead’s second-quarter earnings slides . When asked for more details, a Gilead spokesperson said the partial impairment charge was “related to the changing competitive dynamics in indications Hepcludex is being developed for.”

SAN FRANCISCO, CA, USA I August 06, 2025 I Vir Biotechnology, Inc. (Nasdaq: VIR) today announced the enrollment of the first participant in ECLIPSE 3. All three trials in the Company’s registrational ECLIPSE program for chronic hepatitis delta (CHD) have now been initiated. ECLIPSE 3 is a Phase 2b trial designed to compare the combination of tobevibart and elebsiran to bulevirtide treatment in patients with CHD. ECLIPSE 3 will provide important supportive data to help establish access and reimbursement in key markets. “We believe our registrational ECLIPSE program will validate the potential of our combination of tobevibart and elebsiran to establish a new standard of care in both newly diagnosed and previously treated patients with chronic hepatitis delta.” Share “People living with chronic hepatitis delta urgently need new options to treat their disease,” said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. “With the strong foundation of our previous data and the proven expertise of our team, we believe our registrational ECLIPSE program will validate the potential of our combination of tobevibart and elebsiran to establish a new standard of care in both newly diagnosed and previously treated patients with chronic hepatitis delta.” “We are encouraged by the high rates of viral suppression demonstrated by the combination of tobevibart and elebsiran in our Phase 2 SOLSTICE study,” said Mark Eisner, M.D., M.P.H., Chief Medical Officer, Vir Biotechnology. “Taken together, our ECLIPSE trials are designed to demonstrate the potential of our tobevibart and elebsiran combination therapy, including breadth of response and dosing convenience. These are key aspects for improving patients’ quality of life and supporting long-term treatment adherence in real-world settings.” CHD is an area of significant unmet medical need, with no approved treatments in the U.S. and limited options globally. CHD is the most severe form of chronic viral hepatitis, 1 with people living with the disease rapidly progressing to cirrhosis, liver failure 2 and liver-related death. 1 The objective of therapy is to eliminate the virus. Tobevibart in combination with elebsiran offers the potential to achieve this by tackling the viral lifecycle through multiple mechanisms. The potential of the combination of tobevibart and elebsiran has been recognized by Breakthrough Therapy and Fast Track designations from the U.S. Food and Drug Administration (FDA), along with Priority Medicines (PRIME) and orphan drug status from the European Medicines Agency (EMA). These designations support the expedited development of treatments for serious diseases where there is a significant unmet medical need. About the ECLIPSE Registrational Program ECLIPSE is a registrational program to evaluate the safety and efficacy of tobevibart in combination with elebsiran in patients with chronic hepatitis delta (CHD). ECLIPSE includes three randomized, controlled trials designed to evaluate the combination therapy in comparison to deferred treatment or bulevirtide. ECLIPSE 1 ( NCT06903338 ) is a Phase 3 trial evaluating the safety and efficacy of tobevibart in combination with elebsiran compared to deferred treatment in the U.S. or other regions where bulevirtide use is limited. ECLIPSE 2 is a Phase 3 trial that will evaluate the efficacy and safety of switching to tobevibart and elebsiran in people with CHD who have not achieved viral suppression with bulevirtide therapy. ECLIPSE 1 and 2 are designed to provide the registrational efficacy and safety data needed for potential submission to global regulatory agencies, and both trials are currently recruiting. ECLIPSE 3 is a Phase 2b head-to-head trial to evaluate tobevibart and elebsiran compared with bulevirtide in bulevirtide-naïve patients, and it is designed to provide important supportive data to help establish access and reimbursement in key markets. ECLIPSE 3 plans to enroll participants who have never received bulevirtide for the treatment of CHD. Participants will be randomized 2:1 to receive the combination of tobevibart and elebsiran or bulevirtide. The primary endpoint in ECLIPSE 3 measures hepatitis delta virus (HDV) RNA at the lower limit of quantification target not detected, HDV RNA TND (defined as HDV RNA = 0 IU/mL), at Week 48. About Tobevibart and Elebsiran Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen (HBsAg). It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart was identified using Vir Biotechnology’s proprietary monoclonal antibody discovery platform. The Fc domain has been engineered to increase immune engagement and clearance of HBsAg immune complexes and incorporates Xencor’s Xtend™ technology to extend half-life. Tobevibart is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta. Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) discovered by Alnylam Pharmaceuticals, Inc. It is designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. Current data indicate that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. Elebsiran is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta. About Vir Biotechnology, Inc. Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology routinely posts information that may be important to investors on its website. References: 1 WHO Hepatitis Delta Factsheet – Hepatitis D (who.int) , accessed July 2025 2 CDC What is Hepatitis D – FAQ | CDC , accessed July 2025 SOURCE: Vir Biotechnology