IAVI Scientists and Partners Discuss Access Pathways for New HIV Prevention Options

IAVI’s Kundai Chinyenze, MBChB, Executive Medical Director

Coinciding with World AIDS Day on December 1, IAVI scientists and partners have called for action on ensuring access to promising HIV prevention tools. In two recent collaboratively authored publications, they point to the need for an expanded global commitment to HIV vaccine development and suggest a suite of regulatory, policy, and implementation activities to ensure that new HIV prevention tools reach the people who need them most.

In Lancet, IAVI’s President and CEO Mark Feinberg, M.D., Ph.D., along with other global leaders in HIV/AIDS prevention, describes what it will take for an HIV vaccine to be rolled out quickly and widely once it is shown to be safe and effective. In “The Complex Challenges of HIV Vaccine Development Require Renewed and Expanded Global Commitment,” the authors point to the need for regulatory, procurement, and implementation plans to ensure that an HIV vaccine is made available as quickly as possible. Additionally, they call for increased funding for HIV prevention research and the need for strengthening the pipeline of early stage HIV vaccine candidates.

IAVI Senior Technical Advisor Patricia E. Fast, M.D., Ph.D., and Executive Medical Director Kundai Chinyenze, MBChB, were co-authors of “HIV Immunoprophylaxis: Preparing the Pathway from Proof of Concept to Policy Decision and Use” in Lancet HIV. The article was based on consultations they and other experts had with the World Health Organization (WHO) and UNAIDS in 2018 on preparations for policy, access, and use of HIV vaccines and monoclonal antibodies. It identifies pathways to licensure and policy decisions for global use of vaccines and antibodies for HIV prevention (antibodies are proteins that can neutralize pathogens).

Chinyenze brought that experience to a November 2019 consultation convened by WHO and UNAIDS on ethical considerations for HIV prevention clinical trials. The meeting, “Ethical Frameworks and Biomedical HIV Prevention Research in the Era of Highly Effective HIV Prevention,” was designed to lead to the update of the 2007 UNAIDS/WHO publication “Ethical Considerations in Biomedical HIV Prevention Trials,” which provides guidance on key ethical issues related to the design, implementation, and follow up of HIV prevention trials. The meeting convened stakeholders from across a range of sectors, including investigators, clinical trial sponsors, civil society organizations, national and regional regulatory authorities, ethicists, and biostatisticians. Given that highly effective HIV prevention is now available, a new set of standards for clinical trials is necessary to ensure that participants have access to new HIV prevention innovations that are non-inferior or superior to the standard of prevention/care.

A draft revision of the 2007 guidance document for ethical HIV research practices will be published by the WHO and available for public comment.

Clearly, momentum is building in global health to prepare for next steps following highly anticipated results from efficacy-stage vaccine and antibody studies and to support other novel HIV prevention candidates in earlier stages of development.

References

Bekker LG, Tatoud R, Dabis F, et al. The complex challenges of HIV vaccine development require renewed and expanded global commitment [published online December 2, 2019]. Lancet. doi:10.1016/S0140-6736(19)32682-0

Vekemans J, William, Fast PE, et al. HIV immunoprophylaxis: preparing the pathway from proof of concept to policy decision and use [published online November 27, 2019]. Lancet HIV. doi:10.1016/S2352-3018(19)30294-2

Many experts think that a vaccine capable of eliciting broadly neutralizing antibodies (bnAbs) capable of blocking HIV infection will be needed to end the epidemic. IAVI and others are exploring vaccination strategies to lead to bnAb production in healthy people and are investigating administering bnAbs themselves as prevention. Support from the U.S. Agency for International Development has enabled this work.