U.S. FDA approves the world's only twice-a-year shot to prevent HIV

A pharmacist holds a vial of lenacapavir, an injectable HIV prevention drug, at the Desmond Tutu Health Foundation's Masiphumelele Research Site, in Cape Town, South Africa, Tuesday, July 23, 2024, which was one of the sites for Gilead's lenacapavir drug trial. (AP Photo/Nardus Engelbrecht, File)
WASHINGTON — The U.S. has approved the world's only twice-a-year shot to prevent HIV, maker Gilead Sciences announced Wednesday. It's the first step in an anticipated global rollout that could protect millions – although it's unclear how many in the U.S. and abroad will get access to the powerful new option.
While a vaccine to prevent HIV still is needed, some experts say the shot — a drug called lenacapvir — could be the next best thing. It nearly eliminated new infections in two groundbreaking studies of people at high risk, better than daily preventive pills they can forget to take.
'This really has the possibility of ending HIV transmission,' said Greg Millett, public policy director at amfAR, The Foundation for AIDS Research.
Condoms help guard against HIV infection if used properly but what's called PrEP — regularly using preventive medicines such as the daily pills or a different shot given every two months — is increasingly important. Lenacapavir's six-month protection makes it the longest-lasting type, an option that could attract people wary of more frequent doctor visits or stigma from daily pills.
But upheaval in U.S. healthcare — including cuts to public health agencies and Medicaid — and slashing of American foreign aid to fight HIV are clouding the prospects.
Millett said 'gaping holes in the system' in the U.S. and globally 'are going to make it difficult for us to make sure we not only get lenacapavir into people's bodies but make sure they come back' even as little as twice a year.
Gilead's drug already is sold to treat HIV under the brand name Sunlenca. The prevention dose will be sold under a different name, Yeztugo. It's given as two injections under the skin of the abdomen, leaving a small 'depot' of medication to slowly absorb into the body.
Gilead didn't immediately announce its price. The drug only prevents HIV transmission – it doesn't block other sexually transmitted diseases.
Global efforts at ending the HIV pandemic by 2030 have stalled. There still are more than 30,000 new infections in the U.S. each year and about 1.3 million worldwide.
Only about 400,000 Americans already use some form of PrEP, a fraction of those estimated to benefit. A recent study found states with high use of PrEP saw a decrease in HIV infections, while rates continued rising elsewhere.
About half of new infections are in women, who often need protection they can use without a partner's knowledge or consent. One rigorous study in South Africa and Uganda compared more than 5,300 sexually active young women and teen girls given twice-yearly lenacapavir or the daily pills. There were no HIV infections in those receiving the shot while about two per cent in the comparison group caught HIV from infected sex partners.
A second study found the twice-yearly shot nearly as effective in gay men and gender-nonconforming people in the U.S. and in several other countries hard-hit by HIV.
Ian Haddock of Houston had tried PrEP off and on since 2015 but he jumped at the chance to participate in the lenacapavir study and continues with the twice-yearly shots as part of the research follow-up.
'Now I forget that I'm on PrEP because I don't have to carry around a pill bottle,' said Haddock, who leads the Normal Anomaly Initiative, a nonprofit serving Black LGBTQ2S+ communities.
'Men, women, gay, straight – it really just kinds of expands the opportunity for prevention,' he added. Just remembering a clinic visit every six months 'is a powerful tool versus constantly having to talk about, like, condoms, constantly making sure you're taking your pill every day.'
'Everyone in every country who's at risk of HIV needs access to PrEP,' added Dr. Gordon Crofoot of Houston, who helped lead the study in men. 'We need to get easier access to PrEP that's highly effective like this is.'
Lauran Neergaard, The Associated Press

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Curious to see the graphical version of these numbers? The ovarian cancer infographic is ready for you. Check it out here! Ovarian Cancer Overview Ovarian cancer is a complex and often late-diagnosed malignancy arising from the epithelial cells, stromal cells, or germ cells of the ovary. Among these, epithelial ovarian cancer is the most prevalent, accounting for over 90% of malignant ovarian tumors. Due to its subtle early symptoms and lack of reliable screening methods, the disease is frequently diagnosed at advanced stages, contributing to its high mortality rate among gynecological cancers. The most common and aggressive subtype is High-Grade Serous Ovarian Cancer (HGSOC), which often presents with widespread peritoneal metastases. In contrast, Low-Grade Serous Ovarian Cancer (LGSOC) tends to follow a more indolent course but shows resistance to standard chemotherapy, highlighting a critical unmet need for targeted therapies. Genetic mutations such as BRCA1/2 and alterations in the MAPK pathway (BRAF/KRAS/NRAS/NF1) and homologous recombination deficiency (HRD) status play a pivotal role in disease stratification and therapy selection. Over the past decade, the ovarian cancer treatment landscape has evolved with the introduction of PARP inhibitors, anti-angiogenic agents, and targeted therapies that have significantly improved outcomes in biomarker-driven subpopulations. Despite these advancements, resistance development, limited options for certain subtypes like LGSOC, and high relapse rates continue to challenge long-term disease control. As research progresses, efforts are focused on improving early diagnosis, personalizing treatment based on molecular profiling, and expanding therapeutic options through clinical trials and novel drug development. Get a free sample for the Ovarian Cancer market forecast, size & share analysis report: Ovarian Cancer Epidemiology The epidemiology section offers an overview of historical, current, and projected trends in the seven major countries (7MM) from 2020 to 2034. It helps identify the factors influencing these trends by examining various studies and perspectives from key opinion leaders. Additionally, the section provides an in-depth analysis of the diagnosed patient population and future trends. Ovarian Cancer Epidemiology Segmentation: The Ovarian Cancer market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: • Total incident cases of Ovarian Cancer • Age-specific cases of Ovarian Cancer • Type-Specific Cases of Ovarian Cancer • Stage-specific Cases of high and Low-Grade Serous Ovarian Cancer • Biomarker-specific Cases of high and Low-Grade Serous Ovarian Cancer Ovarian Cancer Drugs Uptake and Pipeline Development Activities The Drug Uptake section offers a detailed analysis of the adoption trends of newly launched and upcoming therapies for Ovarian Cancer throughout the study period. It evaluates patient adoption rates, market penetration, and the commercial performance of each therapy, providing a clear understanding of the factors driving or hindering the market acceptance of these treatments. The Therapeutics Assessment further highlights the Ovarian Cancer drugs, demonstrating the most rapid uptake. 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High-grade serous ovarian cancer (HGSOC), the most prevalent subtype, continues to be treated with a combination of surgery and platinum-based chemotherapy. However, the emergence of maintenance therapies—especially PARP inhibitors—has reshaped post-treatment strategies for patients with BRCA or HRD mutations, helping reduce recurrence rates and extend progression-free survival. The future of ovarian cancer care is increasingly personalized, with clinical trials exploring novel options like immunotherapy, vaccine-based approaches, and radiation strategies for advanced or recurrent disease. These innovations reflect a broader trend toward therapies tailored to molecular profiles and disease stage, moving away from one-size-fits-all treatment. However, disparities in access to care remain a major challenge. Socioeconomic, racial, and geographic barriers often limit timely diagnosis and appropriate treatment, particularly in underserved populations. As awareness of BRCA testing and biomarker-driven treatment grows, expanding access to genetic screening and oncology expertise will be crucial. The ovarian cancer market is expected to expand steadily through 2034, driven by rising disease burden, evolving therapeutic options, and a growing emphasis on precision medicine. Addressing current gaps in care delivery, especially among high-risk and underserved groups, will be essential to unlocking the full potential of these medical advancements. Ovarian Cancer Market Drivers • The introduction of PARP inhibitors (e.g., olaparib, niraparib) and other targeted agents based on BRCA and HRD status has revolutionized ovarian cancer treatment, improving survival and reducing recurrence in select patient groups. • Increasing adoption of genetic and molecular testing for BRCA mutations, HRD status, and other biomarkers is enabling personalized treatment strategies, driving demand for advanced therapeutic options. Ovarian Cancer Market Barriers • The absence of reliable early screening methods and vague initial symptoms often lead to diagnosis at advanced stages, limiting curative treatment options and affecting patient outcomes. • Limited access to specialized oncology care, especially in rural and low-income regions, along with underutilization of genetic testing among minority populations, continues to hinder equitable treatment and diagnosis. Scope of the Ovarian Cancer Market Report • Study Period: 2020–2034 • Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]. • Key Ovarian Cancer Companies: Genmab, AstraZeneca, On Target Laboratories, Chipscreen Biosciences, Aravive, Inc., Allarity Therapeutics, Merck KGaA, GlaxoSmithKline, Aprea Therapeutics, Verastem, Inc., Ellipses Pharma, Impact Therapeutics, Inc., BeiGene, Apexigen, Novartis Oncology, VBL Therapeutics, Cristal Therapeutics, Bayer, Regeneron Pharmaceuticals, DCPrime BV, AIM ImmunoTech Inc., Pharmicell Co., Ltd., Shattuck Labs, Inc., Laekna Limited, Celsion, and others. • Key Ovarian Cancer Therapies: Avutometinib + defactinib, Relacorilant, IMFINZI, Rinatabart sesutecan, Olvimulogene nanivacirepvec, Nemvaleukin alfa, Catequentinib, Raludotatug deruxtecan, Luveltamab Tazevibulin, Sacituzumab tirumotecan, Azenosertib (ZN-c3) + Niraparib, TORL-1-23, and others. • Ovarian Cancer Therapeutic Assessment: Ovarian Cancer currently marketed, and Ovarian Cancer emerging therapies. • Ovarian Cancer Market Dynamics: Ovarian Cancer market drivers and Ovarian Cancer market barriers. • Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies. • Ovarian Cancer Unmet Needs, KOL's views, Analyst's views, Ovarian Cancer Market Access and Reimbursement. Table of Contents 1. Ovarian Cancer Market Report Introduction 2. Executive Summary for Ovarian Cancer 3. SWOT analysis of Ovarian Cancer 4. Ovarian Cancer Patient Share (%) Overview at a Glance 5. Ovarian Cancer Market Overview at a Glance 6. Ovarian Cancer Disease Background and Overview 7. Ovarian Cancer Epidemiology and Patient Population 8. Country-Specific Patient Population of Ovarian Cancer 9. Ovarian Cancer Current Treatment and Medical Practices 10. Ovarian Cancer Unmet Needs 11. Ovarian Cancer Emerging Therapies 12. Ovarian Cancer Market Outlook 13. Country-Wise Ovarian Cancer Market Analysis (2020–2034) 14. Ovarian Cancer Market Access and Reimbursement of Therapies 15. Ovarian Cancer Market Drivers 16. Ovarian Cancer Market Barriers 17. Ovarian Cancer Appendix 18. Ovarian Cancer Report Methodology 19. DelveInsight Capabilities 20. Disclaimer 21. About DelveInsight About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform, PharmDelve. Media Contact Company Name: DelveInsight Contact Person: Jatin Vimal Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: Nevada Country: United States Website: