Gilead to provide HIV prevention drug to 2 million people in lower-income countries at cost – STAT

Gilead’s Agreement to Expand Access to HIV Prevention Drug in Low- and Middle-Income Countries

Introduction

Gilead Sciences has formalized an agreement to provide its innovative HIV prevention drug, lenacapavir (marketed as Yeztugo), to up to 2 million people in low- and middle-income countries. This initiative aligns with the Sustainable Development Goals (SDGs), particularly SDG 3 (Good Health and Well-being), by aiming to reduce the global burden of HIV/AIDS.

Details of the Agreement

The Global Fund to Fight AIDS, Tuberculosis and Malaria will be responsible for purchasing and distributing lenacapavir doses under this agreement. Gilead has committed to supplying the drug at a “no profit” price, supporting SDG 17 (Partnerships for the Goals) through collaboration with global health organizations.

Exclusion of PEPFAR and Funding Challenges

• The U.S. government’s President’s Emergency Plan for AIDS Relief (PEPFAR), a major provider of HIV prevention drugs, is not included in this deal.
• PEPFAR’s future is uncertain due to proposed budget cuts, which may impact the rollout of lenacapavir.
• The Global Fund faces budget constraints, partly because it has historically received significant funding from PEPFAR and other donors who have recently reduced foreign aid.

Global Fund’s Commitment and Resource Needs

Global Fund Director Peter Sands emphasized the ambition to reach 2 million people with long-acting pre-exposure prophylaxis (PrEP) but highlighted the need for increased global resources to achieve this goal, reinforcing the importance of SDG 17.

The Global Fund is collaborating with countries and donors to secure funding through a combination of grants and private foundation contributions to support a meaningful rollout, especially in high-burden countries.

Long-Term Access Strategy

1. Gilead previously announced a royalty-free licensing agreement allowing generic manufacturers to produce lenacapavir for 120 low- and middle-income countries.
2. The current deal serves as a bridge to supply doses while generic manufacturers scale up production.
3. However, the agreement is limited to countries eligible for Global Fund support, excluding some middle-income countries.

Concerns and Challenges

• Uncertainty remains regarding regulatory approvals in low- and middle-income countries.
• Gilead has excluded 26 middle-income countries from its voluntary licensing agreements, raising equity concerns.
• Pricing details have not been disclosed, complicating assessments of affordability and access.
• Country-by-country price negotiations in middle-income countries may hinder universal access.

Stakeholder Perspectives

• Advocates call for prompt, affordable, and equitable access to lenacapavir across all eligible countries, supporting SDG 10 (Reduced Inequalities).
• Experts highlight the need for transparent pricing to ensure the drug’s accessibility.
• Gilead’s CEO, Daniel O’Day, affirmed the company’s commitment to tailoring approaches to individual countries and making the drug available globally.
• The company continues engagement with the U.S. government and other global aid organizations to expand access within the 120 countries.

Conclusion

This agreement represents a significant step toward combating the HIV/AIDS pandemic and advancing SDG 3 by expanding access to a highly effective prevention tool. However, achieving universal and equitable access will require sustained global cooperation, adequate funding, and transparent policies, in line with the broader objectives of the Sustainable Development Goals.

1. Sustainable Development Goals (SDGs) Addressed or Connected

1. SDG 3: Good Health and Well-being
   • The article focuses on HIV prevention, treatment access, and combating infectious diseases, which directly relate to ensuring healthy lives and promoting well-being for all ages.
2. SDG 17: Partnerships for the Goals
   • The collaboration between Gilead, The Global Fund, and other stakeholders highlights the importance of global partnerships to achieve health-related goals.
3. SDG 1: No Poverty
   • Access to affordable HIV prevention drugs in low- and middle-income countries supports poverty reduction by improving health outcomes and reducing economic burdens associated with HIV/AIDS.
4. SDG 10: Reduced Inequalities
   • The article discusses equitable access to HIV prevention drugs, addressing inequalities between high-income and low- to middle-income countries.

2. Specific Targets Under the Identified SDGs

1. Under SDG 3: Good Health and Well-being
   • Target 3.3: End the epidemics of AIDS, tuberculosis, malaria, and neglected tropical diseases by 2030.
   • Target 3.b: Support the research and development of vaccines and medicines for communicable diseases that primarily affect developing countries, and provide access to affordable essential medicines and vaccines.
2. Under SDG 17: Partnerships for the Goals
   • Target 17.6: Enhance North-South, South-South, and triangular regional and international cooperation on and access to science, technology, and innovation.
   • Target 17.9: Enhance international support for implementing effective and targeted capacity-building in developing countries to support national plans to implement all the Sustainable Development Goals.
3. Under SDG 1: No Poverty
   • Target 1.3: Implement nationally appropriate social protection systems and measures for all, including floors, and achieve substantial coverage of the poor and vulnerable.
4. Under SDG 10: Reduced Inequalities
   • Target 10.2: Empower and promote the social, economic, and political inclusion of all, irrespective of income or other status.

3. Indicators Mentioned or Implied to Measure Progress

1. Indicator 3.3.1: Number of new HIV infections per 1,000 uninfected population, by sex, age, and key populations.
   • The article discusses the potential of lenacapavir to provide “virtually complete protection” against HIV infection, implying measurement of new infection rates to assess impact.
2. Indicator 3.b.3: Proportion of health facilities that have a core set of relevant essential medicines available and affordable on a sustainable basis.
   • The article highlights access and pricing concerns regarding the HIV prevention drug, implying the need to track availability and affordability of essential medicines.
3. Indicator 17.6.2: Fixed Internet broadband subscriptions per 100 inhabitants, by speed.
   • While not explicitly mentioned, the cooperation between global organizations and countries to roll out the drug suggests the importance of technology and information sharing, relevant to this indicator.
4. Indicator 17.9.1: Dollar value of financial and technical assistance (including through North-South, South-South, and triangular cooperation) committed to developing countries.
   • The article references funding challenges and the need for increased resources from donors and governments, implying monitoring of financial assistance levels.
5. Indicator 1.3.1: Proportion of population covered by social protection systems, by sex, distinguishing children, unemployed persons, older persons, persons with disabilities, pregnant women, newborns, work-injury victims, and the poor and vulnerable.
   • Access to HIV prevention drugs in vulnerable populations relates to social protection coverage.
6. Indicator 10.2.1: Proportion of people living below 50 per cent of median income, by age, sex, and persons with disabilities.
   • Equitable access to medicines can contribute to reducing income-based inequalities, relevant to this indicator.

4. Table of SDGs, Targets, and Indicators

Source: statnews.com