Optimizing HIV Treatment

ICAP is a partner in OPTIMIZE, a consortium using innovation and partnership to accelerate the introduction of better, less expensive antiretroviral treatment (ART) regimens for HIV patients in low- and middle-income countries.

A five-year project funded by PEPFAR through USAID, OPTIMIZE addresses three interrelated domains to spark advancements in HIV treatment: clinical trials and research, product development and formulation, and market access and product introduction. Partners in this effort include Wits Reproductive Health and HIV Institute (Wits RHI), Mylan Laboratories, the University of Liverpool, and the Medicines Patent Pool (MPP).

ICAP’s scope of work is focused on new product introduction and developing a coordinated approach to decrease the time from inclusion of optimized antiretrovirals in global guidelines to national regulatory approval and uptake at scale within high-burden settings and rapid integration into PEPFAR programs. Specifically, ICAP provides technical assistance at the global and country level to enhance market and user understanding, address manufacturing, distribution and policy bottlenecks, and develop advocacy approaches.

In the first year, this work includes a landscape analysis of stakeholder efforts to introduce optimized ART regimens; needs assessments to identify ways to facilitate future product launch and rapid scale-up at a country level; and development of documents and case studies that can be used to advocate for ART optimization with policy- and decision-makers at the country level.

ICAP also brings to the consortium significant expertise in HIV research and is co-investigator on OPTIMIZE’s landmark clinical trial that will compare new ART regimens to standard of care for adult HIV treatment. This research is expected to be instrumental in informing future treatment guidelines lines. ICAP will also lead a number of implementation science studies that reflect the real programmatic use of these HIV drugs, including one that targets adolescents to test approaches to improve ART outcomes in this vulnerable group.