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The UN warns millions will die by 2029 if US funding for HIV programs isn't replaced

The UN warns millions will die by 2029 if US funding for HIV programs isn't replaced

Hamilton Spectator19 hours ago
LONDON (AP) — Years of American-led investment into AIDS programs has reduced the number of people killed by the disease to the lowest levels seen in more than three decades and provided life-saving medicines for some of the world's most vulnerable.
But in the last six months, the sudden withdrawal of U.S. money has caused a 'systemic shock,' U.N. officials warned, adding that if the funding isn't replaced, it could lead to more than 4 million AIDS-related deaths and 6 million more HIV infections by 2029.
A new UNAIDS report released Thursday said the funding losses have 'already destabilized supply chains, led to the closure of health facilities, left thousands of health clinics without staff, set back prevention programs, disrupted HIV testing efforts and forced many community organizations to reduce or halt their HIV activities.'
It also said that it feared other major donors scaled back their support, reversing decades of progress against AIDS worldwide — and that the strong multilateral cooperation is in jeopardy because of wars, geopolitical shifts and climate change.
A 'lifeline' removed
The $4 billion that the United States pledged for the global HIV response for 2025 disappeared virtually overnight in January, when U.S. President Donald Trump ordered that all foreign aid be suspended and later
moved to shutter the U.S. AID agency
.
Andrew Hill, an HIV expert at the University of Liverpool who is not connected to the United Nations, said that while Trump is entitled to spend U.S. money as he sees fit, 'any responsible government would have given advance warning so countries could plan,' instead of stranding patients in Africa where clinics were closed overnight.
The U.S. President's Emergency Plan for AIDS Relief, or
PEPFAR
, was launched in 2003 by U.S. President George W. Bush, the biggest-ever commitment by any country focused on a single disease.
UNAIDS called the program a 'lifeline' for countries with high HIV rates, and said that it supported testing for 84.1 million people, treatment for 20.6 million, among other initiatives. According to data from Nigeria, PEPFAR also funded 99.9% of the country's budget for medicines taken to prevent HIV.
U.N. Assistant Secretary-General Angeli Achrekar, a UNAIDS deputy executive director who was PEPFAR's principal deputy coordinator until January 2023, said the program is under review by the Trump administration though Secretary of State Marco Rubio issued a waiver 'to continue life-saving treatment.'
''The extent to which it will continue in the future, we don't know,' she told a video news conference with U.N. reporters in New York. 'We are cautiously hopeful that PEPFAR will continue to support both prevention and treatment services.'
A gap impossible to fill
In 2024, there were about 630,000 AIDS-related deaths worldwide, per a UNAIDS estimate — the figure has remained about the same since 2022 after peaking at about 2 million deaths in 2004.
Even before the U.S. funding cuts, progress against curbing HIV was uneven. UNAIDS said that half of all new infections are in sub-Saharan Africa.
Tom Ellman of Doctors Without Borders said that while some poorer countries were now moving to fund more of their own HIV programs, it would be impossible to fill the gap left by the U.S.
'There's nothing we can do that will protect these countries from the sudden, vicious withdrawal of support from the U.S.,' said Ellman, head of the group's South Africa medical unit.
Experts also fear another significant loss — data.
The U.S. paid for most HIV surveillance in African countries, including hospital, patient and electronic records, all of which has now abruptly ceased, according to Dr. Chris Beyrer, director of the Global Health Institute at Duke University.
'Without reliable data about how HIV is spreading, it will be incredibly hard to stop it,' he said.
A new drug revives hope
The uncertainty comes in the wake of a
twice-yearly injectable that many hope could end HIV
. Studies published last year showed that the drug from pharmaceutical maker Gilead was 100% effective in preventing the virus.
At a launch event Thursday, South Africa's health minister Aaron Motsoaledi said the country would 'move mountains and rivers to make sure every adolescent girl who needs it will get it,' saying that the continent's past dependence upon US aid was 'scary.'
Last month, the U.S. Food and Drug Administration
approved the drug, called Yeztugo
, a move that should have been a 'threshold moment' for stopping the AIDS epidemic, said Peter Maybarduk of the advocacy group Public Citizen.
But activists like Maybarduk said Gilead's pricing will put it out of reach of many countries that need it. Gilead has agreed to sell generic versions of the drug in 120 poor countries with high HIV rates but has
excluded nearly all of Latin America
, where rates are far lower but increasing.
'We could be ending AIDS,' Maybarduk said. 'Instead, the U.S. is abandoning the fight.'
___
Associated Press writer Edith M. Lederer at the United Nations contributed to this report.
___
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP receives financial support for global health and development coverage in Africa from the Gates Foundation. The AP is solely responsible for all content. Find AP's
standards
for working with philanthropies, a list of supporters and funded coverage areas at
AP.org
.
___
A previous version of this story was corrected to show that the name of the drug is Yeztugo, not Sunlenca.
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ViiV Healthcare data show 89% of treatment-naïve people with HIV choose to switch to long-acting injectable
ViiV Healthcare data show 89% of treatment-naïve people with HIV choose to switch to long-acting injectable

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ViiV Healthcare data show 89% of treatment-naïve people with HIV choose to switch to long-acting injectable

LONDON--(BUSINESS WIRE)--ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced data from the phase IIIb VOLITION study demonstrating that 89% (n=129/145) of eligible treatment-naïve people living with HIV opted to switch to long-acting injectable Vocabria + Rekambys (branded as Cabenuva in the US Canada and Australia) following rapid viral suppression with daily Dovato (dolutegravir/lamivudine (DTG/3TC)). Additional real-world data from other studies reinforce CAB+RPV LA's effectiveness across a broad range of populations. Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, said: 'Data from the VOLITION study highlight how providing choice in HIV care empowers individuals to choose medicines that meet their evolving everyday needs. ViiV pioneered long-acting injectables for HIV, and we now have over three years of robust real-world evidence demonstrating the impact our portfolio is having today across a broad range of settings and populations. Long-acting injectables provide options that can offer high effectiveness and tolerability, improved adherence, and a preferred dosing schedule compared with daily oral pills. We believe they are a key part of HIV treatment and prevention and will play a critical role in achieving our ambition of ending HIV and AIDS.' Data summary from ViiV Healthcare and partner studies at IAS 2025: Empowering choice: 89% of treatment-naïve people with HIV opt for CAB+RPV LA after achieving rapid viral suppression: These new data from the phase IIIb VOLITION study evaluate the experience of treatment-naïve individuals who initiated treatment with daily DTG/3TC pills and were subsequently offered the choice to switch to CAB+RPV LA after achieving viral suppression. Study results showed that participants achieved rapid viral suppression with DTG/3TC (median time to suppression: 4.14 weeks), following which they were offered to switch. At the immediate next study visit (Day of Choice), 89% (n=129/145) of eligible participants chose to switch to CAB+RPV LA, while 11% (n=16) opted to continue DTG/3TC. The most common reasons cited for choosing CAB+RPV LA were not having to worry about missing a dose each day (80%) and not having to carry medication (68%).These findings underscore the efficacy and tolerability of DTG/3TC as a rapid suppression option, and demonstrate the value of offering CAB+RPV LA as a treatment option to meet individual needs and preferences. 1 CAB+RPV LA d elivers sustained effectiveness and enhanced patient experience in real-world settings: Data from multiple real-world observational studies, including the two-year BEYOND study in the US, the CARLOS study in Germany, the COMBINE-2 cohort across seven European countries, and the OPERA study, consistently reinforce the high effectiveness, favourable outcomes and patient satisfaction associated with CAB+RPV LA. 2,3,4,5,6,7 BEYOND is a two-year prospective observational study enrolling people with HIV following the decision to switch to CAB+RPV LA across 27 U.S. sites. 2 Among the 308 participants, 97% maintained virologic suppression at Month 24 (at most recent viral load of <50 copies/ml), with infrequent discontinuations due to injection reactions and no new confirmed virologic failures after Month 6. Participants reported reduced stigma and improved treatment satisfaction. 3 Similarly, the real-world CARLOS study of 351 participants in Germany, showed 77.5% virologic suppression at Month 24, with high adherence (94.2% on-time injections) and clinically meaningful improvements in treatment satisfaction. 4 97.7% of participants maintained virologic suppression at last known viral load at Month 24 or at discontinuation. In Europe, the COMBINE-2 study, evaluating real-world outcomes for 956 virologically suppressed people with HIV initiating CAB+RPV LA across seven European countries, reported 99% virologic suppression at last measured viral load (median follow-up of 10.2 months), with low rates of confirmed virologic failure (0.5%) and high persistence (92% remaining on therapy). 5 Real-world evidence focussed on the effectiveness of CAB+RPV LA outside the labelled indication in viraemic patients: The large-scale OPERA study further explored the effectiveness of CAB+RPV LA in treatment-experienced individuals initiating therapy with detectable viral loads and long-standing HIV. Among the 3,304 participants, 11% (368 individuals) initiated with baseline viremia (>50 copies/mL), of these, 88% achieved viral suppression to <50 copies/mL (of n=277/313 with ≥ 1 viral load during follow-up and VL<50 copies/mL at any point during follow-up). A separate analysis also showed that among a diverse group of 105 women initiating CAB+RPV LA with viremia, most achieved viral suppression (of 92 women with ≥1 VL at follow-up, 92% achieved VL <50 copies/mL at any point during follow up), with confirmed virologic failure being rare. 6,7 Through these findings, CAB+RPV LA was shown to address challenges associated with daily oral pills, offering improved treatment satisfaction, high effectiveness and a patient-preferred treatment option that supports long-term virologic control. Implementation studies highlight CAB LA for PrEP is highly preferred and easy to implement for key prevention groups: The PILLAR and EBONI studies highlight the high acceptability and feasibility of CAB LA for PrEP for HIV prevention in broad populations, including men who have sex with men (MSM), transgender men (TGM), and Black women (BW). 8,9 PILLAR is a phase IV implementation trial assessing the integration of CAB LA for PrEP across 17 clinics in the U.S. among a broad population of MSM and TGM (n=201). 8 CAB LA for PrEP was rated highly acceptable (mean 4.6/5 at Month 12) and feasible (mean 4.4/5), with 95% of participants (n=131) who switched from oral PrEP reporting being happy with the choice and 98% recommending CAB LA for PrEP (n=140). Flexible scheduling, reminders, and educational tools supported adherence, while stigma concerns were significantly lower compared to oral PrEP users. Similarly, EBONI, an implementation study evaluating CAB LA for PrEP in Black cis and transgender women, among women's health clinics, across 72 healthcare provider respondents at 15 clinics primary care and infectious disease clinics in the US. Data found CAB LA for PrEP highly appropriate (mean 4.5/5) and feasible (mean 4.4/5) for Black women. 9 In addition, clinic capacity to accommodate CAB LA for PrEP tripled within a year without increasing staff or time commitment. The health benefits of two monthly visits included additional opportunities to screen for STIs, screening for comorbidities or providing other health or psychological care. These findings highlight Apretude 's potential to support broader PrEP implementation and improve outcomes in underserved populations who may benefit the most across varied clinical settings. Trademarks are owned by or licensed to the ViiV Healthcare group of companies. About Apretude (cabotegravir long-acting for PrEP) Apretude is a medicine used for preventing sexually transmitted HIV-1 infection (pre-exposure prophylaxis or PrEP) in adults and adolescents weighing at least 35 kg who are at high risk of being infected. Individuals must have a negative HIV-1 test prior to initiating Apretude (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP. It should be used in combination with safer sex practices, such as using condoms. Apretude contains the active substance cabotegravir. Please consult the full Summary of Product Characteristics for all the safety information: Apretude 600 mg prolonged-release suspension for injection About Vocabria (cabotegravir) Vocabria injection is indicated - in combination with rilpivirine injection - for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents (at least 12 years of age and weighing at least 35kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside reverse transcriptase inhibitors (NNRTI) and integrase inhibitor (INI) class. Vocabria tablets are indicated - in combination with rilpivirine tablets - for the short-term treatment of HIV-1 infection in adults and adolescents (at least 12 years of age and weighing at least 35kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class for: oral lead in to assess tolerability of Vocabria and rilpivirine prior to administration of long acting Vocabria injection plus long acting rilpivirine injection. oral therapy for adults who will miss planned dosing with Vocabria injection plus rilpivirine injection. Vocabria tablets are only indicated for treatment of HIV-1 in combination with rilpivirine tablets, therefore, the prescribing information for Edurant (rilpivirine) tablets should also be consulted for recommended dosing. Please consult the full Summary of Product Characteristics for all the safety information: Vocabria 400mg/600 mg prolonged-release suspension for injection and Vocabria 30 mg film-coated tablets About Rekambys (rilpivirine) Rekambys is indicated - in combination with cabotegravir injection - for the treatment of HIV-1 infection in adults and adolescents (at least 12 years of age and weighing at least 35kg) who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the NNRTI and INI class. Rekambys should always be co-administered with a cabotegravir injection. The prescribing information for cabotegravir injection should be consulted for recommended dosing. Rekambys may be initiated with oral lead-in or without (direct to injection). Please consult the full Summary of Product Characteristics for all the safety information: Rekambys 600mg/900 mg prolonged-release suspension for injection About Cabenuva (cabotegravir + rilpivirine) Cabenuva is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 c/ml) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. The complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen Sciences Ireland Unlimited Company. Rilpivirine tablets are approved in the US and when used with cabotegravir is indicated for short-term treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35 kg who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. INSTIs inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic disease. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which stops the virus from multiplying. Please consult the full Prescribing Information here. About Dovato (dolutegravir and lamivudine) Dovato is indicated as a complete regimen to treat HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40kg, in the EU, and weighing at least 25kg in the US, with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of Dovato. Please consult the full Summary of Product Characteristics for all the safety information: Dovato 50 mg/300 mg film-coated tablets. About ViiV Healthcare ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who could benefit from HIV prevention. Shionogi became a ViiV shareholder in October 2012. The company's aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the 'Risk Factors' section in GSK's Annual Report on Form 20-F for 2024, and GSK's Q1 Results for 2025. References 1 F. Felizarta, et al. The power of choice: strong preference for CAB+RPV LA following rapid suppression with DTG/3TC in treatment naive people living with HIV. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 2 F. Felizarta, et al. Perspectives of people living with HIV (PWH) 24 months following a switch to cabotegravir and rilpivirine long-acting (CAB+RPV LA) in an observational real-world US study (BEYOND). Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 3 G. Blick, et al. Clinical outcomes at month 24 after initiation of cabotegravir and rilpivirine long acting (CAB+RPV LA) in an observational real-world study (BEYOND). Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 4 C. Wyen, et al. 24-month outcomes of cabotegravir+rilpivirine long-acting every 2 months in a real‑world setting: effectiveness, adherence to injections, and participant-reported outcomes from people with HIV-1 in the German CARLOS cohort. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 5 A. Pozniak, et al. High virologic suppression and few virologic failures with Long-Acting Cabotegravir + Rilpivirine in Treatment Experienced Virologically Suppressed Individuals from COMBINE-2 cohort in Europe. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 6 R. Hsu, et al. Real-world effectiveness of CAB+RPV LA in individuals with HIV viremia at therapy initiation. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 7 J. Altamirano, et al. Clinical outcomes among women in the OPERA cohort initiating CAB+RPV LA with viral loads ≥ 50 copies/mL. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 8 D. Dandachi, et al. One-year implementation outcomes of cabotegravir long-acting injectable PrEP in men who have sex with men (MSM) & transgender men (TGM): findings from the PILLAR study. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 9 Z. Tims-Cook, et al. Health care provider experiences after 12 months of implementing cabotegravir long-acting injectable PrEP (CAB LA) for Black women: EBONI study results. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW.

Merck to Initiate Phase 3 Trials for Investigational Once-Monthly HIV Prevention Pill
Merck to Initiate Phase 3 Trials for Investigational Once-Monthly HIV Prevention Pill

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Merck to Initiate Phase 3 Trials for Investigational Once-Monthly HIV Prevention Pill

BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of the EXPrESSIVE Phase 3 clinical trials, evaluating the safety and efficacy of MK-8527, an investigational once-monthly, oral nucleoside reverse transcriptase translocation inhibitor (NRTTI) for HIV pre-exposure prophylaxis (PrEP). The EXPrESSIVE-11 (MK-8527-011, NCT 07044297) trial will evaluate the safety and efficacy of MK-8527 among people with greater likelihood of HIV-1 exposure in 16 countries and will begin enrolling in August 2025. In collaboration with the Gates Foundation, the EXPrESSIVE-10 (MK-8527-010) trial will evaluate the safety and efficacy of MK-8527 in women and adolescent girls in sub-Saharan Africa and will begin enrolling in the next few months. 'According to UNAIDS, 1.3 million people acquired HIV in 2023, highlighting the continued need for new PrEP options like our investigational once-monthly, oral PrEP candidate MK-8527, especially among women in sub-Saharan Africa and men who have sex with men, who experience disproportionately high rates of HIV,' said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. 'Our collaboration with the Gates Foundation will help us explore the potential of MK-8527 to contribute to global efforts to reduce the number of HIV infections and help support opportunities to accelerate access around the world.' The decision to initiate the Phase 3 clinical trial program was supported by the results of a double-blind, multicenter, Phase 2 trial (MK-8527-007, NCT 06045507) examining the safety and pharmacokinetics of MK-8527. The study enrolled 350 participants, 18–65 years of age, with low likelihood of HIV-1 exposure, who were randomized 2:2:2:1 to receive MK-8527 (3, 6, or 12 mg) or placebo once monthly for six months. In the trial, the rates of adverse events were similar among those in the MK-8527 arms and those in the placebo arm, and no clinically meaningful changes were seen in laboratory tests, including total lymphocyte and CD4 T-cell counts. The pharmacokinetics of MK-8527 and MK-8527-TP, the active form of MK-8527, support the continued development of MK-8527 as an oral, once-monthly option for PrEP. Results from the Phase 2 trial were highlighted in the opening press conference for IAS 2025, the 13th International AIDS Society Conference on HIV Science in Kigali, Rwanda, on Monday, July 14, at 15:30 – 16:30 CAT, titled 'Breakthroughs Amid Crisis: The Future of HIV Innovation.' These research findings will be further detailed in a late-breaker oral session on Wednesday, July 16, at 12:15 – 13:15 CAT. 'Scientific advances against HIV have brought us further than ever imagined and are ushering in a new era in HIV prevention,' said Trevor Mundel, president of global health at the Gates Foundation. 'With only 18% of global PrEP need currently met, there is a clear and urgent need for options like MK-8527 that may offer the ability to prevent infection. These Phase 3 trials are a key step toward translating progress into longer-acting options that could help turn the tide on HIV.' In the EXPrESSIVE-10 trial, the International Clinical Research Center (ICRC) within the University of Washington Department of Global Health, in partnership with the University of Alabama at Birmingham, will receive grant funding from the Gates Foundation to support ICRC's collaboration with 31 clinical research trial sites in Kenya, South Africa, and Uganda; sites will inform and engage communities and recruit, enroll, and follow women who participate in the EXPrESSIVE-10 trial. Merck will be the trial sponsor, gaining regulatory and customs approvals, and providing operational expertise and resources for management of the trials. The Gates Foundation will also provide support for global community advisory groups, which will offer insight into community perspectives on a monthly PrEP pill, participant recruitment materials and strategies, and cultural considerations for these trials. Separately, the Gates Foundation will provide grant funding for EXPrESSIVE-11 to support the establishment of a community advisory group and the development of recruiting and retention materials only. About the EXPrESSIVE MK-8527 Phase 3 Clinical Trial Program The EXPrESSIVE-11 trial (MK-8527-011, NCT 07044297) is a randomized, active-controlled study enrolling 4,390 sexually active people who could benefit from PrEP across trial sites in 16 countries. The primary objective of the study is to evaluate the efficacy, safety, and tolerability of once-monthly oral MK-8527 compared to daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) as assessed by the incidence rate per year of adjudicated HIV-1 infections. The trial will begin enrolling in August 2025. The EXPrESSIVE-10 trial (MK-8527-010) is a randomized, active-controlled study enrolling 4,580 sexually active women aged 16 to 30 in Kenya, South Africa, and Uganda. The primary objective of the study is to evaluate the efficacy, safety, and tolerability of once-monthly oral MK-8527 compared to daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) as assessed by the incidence rate per year of adjudicated HIV-1 infections. The study will begin enrolling in the next few months. About MK-8527 MK-8527 is being evaluated as a potential once-monthly oral prevention option for HIV-1. MK-8527 inhibits reverse transcriptase through multiple mechanisms of action, including inhibition of translocation and delayed chain termination. For an overview of Merck's complete HIV treatment and prevention clinical development program, please click here. Merck's Commitment to HIV For more than 35 years, Merck has been committed to scientific research and discovery in HIV, leading to scientific breakthroughs that have helped change HIV treatment. Our work has helped pioneer the development of new options across multiple drug classes to help those impacted by HIV. Today, we are developing a series of antiviral options designed to help people manage their HIV and to help prevent HIV, with the goal of reducing the growing burden of HIV worldwide. We want to ensure people are not defined by HIV, and our work focuses on transformational innovations, collaborations with others in the global HIV community, and access initiatives aimed at helping to end the HIV epidemic for everyone. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable, and healthy future for all people and communities. For more information, visit and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube, and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the 'company') includes 'forward-looking statements' within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2024 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (

Gilead Presents New Data on Twice-Yearly Lenacapavir (Yeztugo
Gilead Presents New Data on Twice-Yearly Lenacapavir (Yeztugo

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Gilead Presents New Data on Twice-Yearly Lenacapavir (Yeztugo

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that Gilead researchers and collaborators will present new Phase 3 PURPOSE trial data at IAS 2025 showing that twice-yearly lenacapavir (Yeztugo ®) was effective and well tolerated among a broad range of populations who need or want pre-exposure prophylaxis (PrEP) for HIV prevention, including pregnant and lactating women, adolescents and young people, and supports lenacapavir dosing recommendations for people in special situations, such as those taking medication to treat tuberculosis (TB) and other conditions. Researchers will also present new quantitative and qualitative data showing that participants in both Phase 3 PURPOSE trials indicated a preference for twice-yearly PrEP injections over daily oral medication. The new data, from the company's pivotal Phase 3 PURPOSE 1 (NCT04994509) and PURPOSE 2 (NCT04925752) trials that assessed the efficacy and safety of twice-yearly Yeztugo for PrEP, will be presented via poster sessions and during a Yeztugo-dedicated oral session at the International AIDS Society (IAS) 2025, the 13 th IAS Conference on HIV Science in Kigali, Rwanda on Thursday, July 17. The data presentations come less than a month after the U.S. Food and Drug Administration (FDA) approved Yeztugo as the first and only twice-yearly HIV prevention option. The data underscore Gilead's focus on intentional inclusion in the PURPOSE program to ensure broad and robust population data at the trials' primary analyses, as well as spotlight the community and organizational collaborations that guided the trial design and implementation process. 'It's a thrill to be back in Kigali with so many of the community, advocacy and research partners who helped make PURPOSE the most intentionally inclusive HIV prevention trial program ever conducted,' said Moupali Das, Vice President of Clinical Development, HIV Prevention & Pediatrics at Gilead Sciences. 'As the first and only twice-yearly PrEP option, Yeztugo continues to demonstrate efficacy and tolerability among diverse populations, and we're excited to highlight new data on this breakthrough HIV prevention option here at IAS 2025.' Yeztugo was Efficacious and Well Tolerated in Trials Among Pregnant and Lactating Women, Adolescents and Young People, and Can Be Administered in People Receiving Treatment for TB and Other Conditions Pregnant and lactating women—who face a heightened likelihood of acquiring HIV—have historically been excluded from HIV prevention trials. Based on input from community meetings in locations including Kigali, Gilead ensured that pregnant and lactating women were included in the Phase 3 PURPOSE 1 trial, which evaluated twice-yearly Yeztugo in cisgender women and adolescent girls in Sub-Saharan Africa. PURPOSE data presented at IAS 2025 show that Yeztugo was efficacious in pregnant and breastfeeding or lactating women, with no new cases of HIV reported among 184 participants in the Yeztugo group (there were a total of 509 pregnancies among 487 participants in PURPOSE 1). Data also show that Yeztugo was well tolerated by these women, that there were similar safety profiles between pregnant and non-pregnant women, and that there were no clinically significant differences in predicted Yeztugo exposure by pregnancy trimester or postpartum status. Additionally, exposure in breastfed infants was minimal. Young people aged 16-25 years are also at an increased likelihood of experiencing HIV acquisition globally, but, like pregnant women, are often not proactively included in Phase 3 HIV prevention trials. Gilead intentionally included this population in the PURPOSE 1 trial and the PURPOSE 2 trial, which evaluated twice-yearly Yeztugo among a broad and geographically diverse range of cisgender men and gender-diverse people. Data presented at IAS 2025 show that Yeztugo was efficacious in people aged 16-25 years, with zero reported HIV infections in young people receiving Yeztugo in PURPOSE 1 and two HIV infections among young people in PURPOSE 2. Additionally, there were no clinically significant pharmacokinetic differences between the 16-25-year-old group and adults aged over 25 years. Yeztugo was well tolerated across both trials among participants of all ages, with no new safety concerns identified. Globally, those at higher likelihood of HIV acquisition may also be vulnerable to TB, which can be treated by rifamycin-class drugs including rifampin and rifabutin. Yeztugo is a substrate of CYP3A, and strong CYP3A inducers such as rifampin, or moderate inducers such as rifabutin, may potentially lower Yeztugo plasma concentrations. Gilead will present modeling data showing supplemental Yeztugo dosing for strong and moderate CYP3A inducers to allow people receiving Yeztugo to receive rifamycin-containing TB treatment, if necessary. Yeztugo is also a moderate inhibitor of CYP3A and could theoretically increase levels of drugs such as statins for lowering cholesterol or PDE5 inhibitors for treating erectile dysfunction; dosing recommendations for these special situations will also be reviewed. Preference for Twice-Yearly Prevention Option Over Daily Oral PrEP New qualitative and quantitative self-reported data from PURPOSE 1 and PURPOSE 2 show significant preference for twice-yearly injectable PrEP compared with daily oral PrEP among study participants. More than 75% of study participants who were surveyed preferred twice-yearly injectable administration; of these, more than 50% reported a strong preference. Reasons given for favoring twice-yearly injectable PrEP versus daily oral PrEP include feeling more protected from HIV (69%) and feeling more confident about not missing a dose (77%). 'Certain groups—including pregnant and lactating women, adolescents and young people—are disproportionately affected by HIV, yet have long been underrepresented in HIV clinical trials,' said Linda-Gail Bekker, MBChB, DTM&H, DCH, FCP(SA), PhD, Director of the Desmond Tutu HIV Center at the University of Cape Town, South Africa, and former President of the International AIDS Society. 'The PURPOSE program set a new standard for innovative, intentional inclusion by ensuring we would have safety and efficacy data in these populations from the outset. The results not only show that Yeztugo provides strong protection against HIV and was well tolerated in these groups, but also highlight the critical need for PrEP options that reflect people's preferences—reducing barriers to uptake and helping close persistent gaps in prevention.' Continued Global Regulatory Filings for Lenacapavir for PrEP, as Well as Milestone Partnerships On June 18, 2025, Gilead received FDA approval for Yeztugo as PrEP to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg. Gilead has also submitted a marketing authorization application (MAA) and EU-Medicines for all (EU-M4all) application with the European Medicines Agency (EMA), both of which the EMA has validated and will review under an accelerated assessment timeline. Gilead has also filed for regulatory approval for twice-yearly lenacapavir for PrEP with authorities in Australia, Brazil, Canada, South Africa and Switzerland. Additionally, now that lenacapavir has received FDA approval for PrEP, Gilead is preparing additional filings in countries that rely on stringent regulatory authority approvals for regulatory submission, including Argentina, Mexico and Peru. Gilead will continue to share updates on additional regulatory filings. Lenacapavir for HIV prevention is not approved by any regulatory authority outside of the United States. Last week, Gilead announced a strategic partnership agreement with The Global Fund to Fight AIDS, Tuberculosis and Malaria to supply enough doses of lenacapavir, at no profit to Gilead, to reach up to two million people over three years in countries supported by the Global Fund and that are included in Gilead's voluntary licensing agreements for lenacapavir. There is currently no cure for HIV or AIDS. Please see below for U.S. Indication and Important Safety Information, including Boxed Warning, for Yeztugo. About the PURPOSE Program Gilead's landmark PURPOSE program is the most comprehensive and diverse HIV prevention trial program ever conducted. The program comprises five HIV prevention trials around the world that are focused on innovation in science, trial design, community engagement and health equity. The PURPOSE trials are evaluating the safety and efficacy of the, twice-yearly injectable medicine, lenacapavir, to reduce the chance of getting HIV. The Phase 2 and 3 program, consisting of PURPOSE 1-5, is assessing the potential of lenacapavir to help a diverse range of people around the world who could benefit from PrEP. More information about the PURPOSE program, including individual trial descriptions, populations and locations, can be found at About Lenacapavir Lenacapavir is approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals. Lenacapavir is also approved in the United States to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg who are at risk of HIV acquisition. The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes. Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead's HIV prevention and treatment research program. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV. The journal Science named lenacapavir its 2024 'Breakthrough of the Year.' U.S. Indication for Yeztugo Yeztugo (lenacapavir) injection, 463.5 mg/1.5 mL, is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents (>35kg) who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating Yeztugo. U.S. Important Safety Information for Yeztugo BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF YEZTUGO IN UNDIAGNOSED HIV-1 INFECTION Individuals must be tested for HIV-1 infection prior to initiating Yeztugo, and with each subsequent injection of Yeztugo, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of Yeztugo by individuals with undiagnosed HIV-1 infection. Do not initiate Yeztugo unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving Yeztugo must transition to a complete HIV-1 treatment regimen. Contraindications Yeztugo is contraindicated in individuals with unknown or positive HIV-1 status. Warnings and precautions Comprehensive risk management: Use Yeztugo to reduce the risk of HIV-1 acquisition as part of a comprehensive prevention strategy including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). HIV-1 acquisition risk includes behavioral, biological, or epidemiologic factors including, but not limited to, condomless sex, past or present STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high-prevalence area or network. Counsel individuals on the use of other prevention methods to help reduce their risk. Use Yeztugo only in individuals confirmed to be HIV-1 negative. Evaluate for current or recent signs or symptoms consistent with HIV-1 infection. Confirm HIV-1 negative status prior to initiating, prior to each subsequent injection, and as clinically appropriate. Potential risk of resistance: There is a potential risk of developing resistance to Yeztugo if an individual acquires HIV-1 before or when receiving Yeztugo, or following discontinuation. HIV- 1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection taking only Yeztugo, because Yeztugo alone is not a complete regimen for HIV-1 treatment. To minimize this risk, it is essential to test before each injection and additionally as clinically appropriate. Individuals confirmed to have HIV-1 must immediately begin a complete HIV-1 treatment regimen. Alternative forms of PrEP should be considered after discontinuation of Yeztugo for those who are at continuing risk of HIV-1 acquisition and should be initiated within 28 weeks of the last Yeztugo injection. Long-acting properties and potential associated risks: Residual concentrations of Yeztugo may remain in systemic circulation for up to 12 months or longer after the last injection. Select individuals who agree to the required injection dosing schedule because nonadherence or missed doses could lead to HIV-1 acquisition and development of resistance. Serious injection site reactions: Improper administration (intradermal injection) has been associated with serious injection site reactions, including necrosis and ulcer. Only administer Yeztugo subcutaneously. Adverse reactions Most common adverse reactions (≥5%) in Yeztugo clinical trials were injection site reactions, headache, and nausea. Drug interactions Strong or moderate CYP3A inducers may significantly decrease Yeztugo concentrations. Dosage modifications are recommended when initiating these inducers. It is not recommended to use Yeztugo with combined P-gp, UGT1A1, and strong CYP3A inhibitors. Coadministration of Yeztugo with sensitive substrates of CYP3A or P-gp may increase their concentrations and result in the increased risk of their adverse events. Yeztugo may increase the exposure of drugs primarily metabolized by CYP3A initiated within 9 months after the last injection of Yeztugo. Dosage and administration HIV screening: Test for HIV-1 infection prior to initiating, prior to each subsequent injection, and as clinically appropriate using an approved or cleared test for the diagnosis of acute or primary HIV-1 infection. Dosage: Initiation dosing (injections and tablets) followed by once-every-6-months continuation injection dosing. Tablets may be taken with or without food. Initiation: Day 1: 927 mg by subcutaneous injection (2 x 1.5-mL injections) and 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally. Continuation: 927 mg by subcutaneous injection every 6 months (26 weeks) from date of last injection ±2 weeks. Anticipated delayed injections: If scheduled 6-month injection is anticipated to be delayed by more than 2 weeks, Yeztugo tablets may be taken on an interim basis (for up to 6 months) until injections resume. Dosage is 300 mg orally (1 x 300-mg tablet) once every 7 days. Resume continuation injections within 7 days of the last oral dose. Missed injections: If more than 28 weeks have elapsed since the last injection and Yeztugo tablets have not been taken, restart with initiation dosing if clinically appropriate. Dosage modifications of Yeztugo are recommended when initiating with strong or moderate CYP3A inducers. Consult the full Prescribing Information for recommendations. About Gilead HIV For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 13 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead has been recognized as one of the leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead's ability to realize the anticipated benefits from the collaboration; difficulties or unanticipated expenses in connection with the collaboration and the potential effects on Gilead's earnings; Gilead's ability to initiate, progress and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Yeztugo (lenacapavir) (such as PURPOSE 1 and PURPOSE 2); uncertainties relating to regulatory applications and related filing and approval timelines, including regulatory applications for lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir for indications currently under evaluation and, as a result, lenacapavir may never be successfully commercialized for such indications; the risk that physicians may not see the benefits of prescribing Yeztugo; Gilead's ability to effectively manage the access strategy relating to lenacapavir, subject to necessary regulatory approvals; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

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