Microbicides: New HIV Prevention Products for Women

OVERVIEW

USAID has long been a leader in the research and development (R&D) of safe, effective, and affordable microbicides – biomedical products that women can use to protect themselves from HIV infection. USAID especially focuses on the R&D of microbicides that can be sustainably provided in key focus countries in sub-Saharan Africa for the women who need them most, including adolescent girls and young women. Building on the success of these R&D activities, USAID also supports activities to prepare for and speed up the introduction of new microbicide products, including daily oral pre-exposure prophylaxis (PrEP).

USAID IMPACT

USAID, through the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), supports:

• Earlier-stage research for improved prevention products, including those with new active ingredients and innovative delivery systems
• Later-stage development of the most promising and advanced new products, such as vaginal rings, improved oral tablets, and long-acting injectables
• Preparatory activities needed for successful microbicide introduction and access, including targeted behavioral studies, drug-resistance monitoring, implementation and impact modeling, and policy or regulatory development

USAID also focuses on “end-users,” by using research to tailor products to fit into and enhance women’s lives, which have the potential for successful delivery in developing country settings. Research shows that the most effective product use and greatest prevention impact can be achieved when users have a choice to consider several product options – including multi-purpose products that prevent other sexually transmitted infections or pregnancy, as well as HIV, and select the one that best fits their own needs and life circumstances at the time.

Research and Development

USAID supports promising HIV prevention products that are in the later stages of development (e.g., those completing safety and efficacy clinical trials). These are products with the potential to reach regulatory approval within five years and incorporate a range of desirable product characteristics identified through end-user research with women (e.g., related to regimen, duration, reduced side effects, discreetness, etc.). Investments in promising products will be prioritized based on expected potential for impact on the HIV epidemic.

USAID also takes a strategic, forward-looking view to invest in game changing products that have the potential to fill identified gaps in the achievable range of prevention options. Support is provided for targeted research on products with novel characteristics that are expected to significantly increase acceptability and effective use by women at high risk. Prioritizing these game-changing products requires an understanding of the HIV infection drivers and barriers to prevention that determine correct and effective use of currently available products. USAID engages directly with priority populations to understand and respond to their preferences for prevention products. Additionally, investments prioritize product characteristics that reduce the burden on strained health care systems. Targeting and investing in these optimized products now will expedite and expand their future impact.

Introduction and Access

USAID strives to expand access to prevention product options that are currently available (e.g., oral PrEP) to women at high risk of acquiring HIV. The number of countries where oral PrEP is approved for use has increased significantly since 2016 in sub-Saharan Africa, but for a variety of reasons, this has not resulted in strong uptake and adherence. This suggests that implementation gaps and challenges exist between the regulatory and introduction phases of the product development pathway. Addressing these gaps requires research on strategic product introduction that can inform national and local policies.

Long-standing local working relationships and extensive experience with service delivery make USAID well positioned to understand specific country contexts for HIV prevention. USAID fills a unique space by addressing research and technical assistance needs that support the range of activities from regulatory approval of products to subsequent introduction and scale-up.

Future initiatives will expand on research activities for the introduction of oral PrEP and dapivirine vaginal ring, and new prevention products in the pipeline. Initiatives will support countries and programs to adopt lessons learned from PrEP rollout to date, including marketing, country support and adherence counseling, to build on existing service delivery foundations within communities, and use research as needed to overcome barriers to successful and sustainable scale-up.

2020 ACHIEVEMENTS

Dapivirine Vaginal Ring Obtained EMA and WHO Prequalification

• The monthly dapivirine vaginal ring (DVR), developed by the International Partnership for Microbicides (IPM), is the first discreet, long-acting, topical HIV prevention product and is designed to help address women’s unmet need for new prevention methods. Through the USAID Microbicide Program and as part of a Product Development Partnership, USAID has been a key leader in funding the development and testing of the DVR, with more than 16 years of investment in this product.
• The DVR was submitted for review and received a positive scientific opinion from the European Medicines Agency (EMA) Article 58 on July 23, 2020. Through Article 58, the EMA, in collaboration with the World Health Organization (WHO), can provide scientific opinions on high priority human medicines that are intended exclusively for markets outside of the European Union.
• On November 30, 2020, the DVR received WHO Prequalification, which confirms that the ring meets global standards for quality, safety and efficacy. The DVR’s addition to the WHO’s list of prequalified medicines will help guide national and global procurement decisions, pending country regulatory approvals for its use.

Launched CHOICE and PROMISE

• The USAID Microbicide Program recently launched the CHOICE and PROMISE projects.
  • CHOICE addresses technical gaps and supports national scale-up of antiretroviral-based HIV prevention products (collectively referred to as PrEP) in PEPFAR countries through catalytic evidence generation, translation, and research utilization.
  • PROMISE supports early product introduction planning for the monthly dapivirine ring in sub-Saharan Africa, with the goal of shaping the market and establishing a service delivery platform to support future multi-purpose and longer-acting vaginal rings.

Launched a GDA with GILEAD

• A Global Development Alliance (GDA) between USAID and Gilead Sciences was established in 2020, to further the goal of research, development, and introduction of new HIV prevention technologies.

Launched Acceptability Study on the Dual Purpose Pill

• In 2020, USAID through the EECO Project, launched support for a Dual Purpose Pill study in South Africa. Population Council,l in partnership with the Wits Reproductive Health and HIV Institute (Wits RHI), in Johannesburg, South Africa aims to conduct a randomized, open-label, parallel group, two-way crossover study, followed by a six-month open-label choice period to compare adherence to a single capsule versus two separate pills.

Promising Preclinical Results:

• In 2020, we saw promising results for the advancement of multipurpose rings - vaginal rings that address multiple health concerns.
• There is promising data for new HIV prevention delivery systems, including creating an implant that is biodegradable.

Additional Resources

• Read more about global PrEP activities from PrEPwatch
• Learn more about USAID’s Center for Accelerating Innovation and Impact
• Discover research by the Microbicides Trial Network