RESONATE RFP Program

Research to Advance HIV Treatment Outcomes

Gilead supports the research efforts of academic institutions, clinical investigators, and research networks that focus on improving outcomes across the treatment care cascade for people with HIV (PWH).

Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF*) is a complete HIV-1 treatment for adults and children with HIV who weigh at least 14 kilograms and are either new to HIV-1 treatment or replacing their current regimen. The single tablet regimen addresses the unmet needs of most treatment-naïve and virologically suppressed people with HIV and offers a high barrier to resistance and few interactions with other drugs.

Lenacapavir (LEN) is a novel first-in-class capsid inhibitor, which in combination with other antiretroviral(s), is indicated for the treatment of HIV-1 in heavily treatment-experienced (HTE) adults. HTE PWH represent a small portion of the overall population with HIV.

Gilead is making a specific request for research study proposals in the disease area of HIV, as further scientific data are needed on B/F/TAF and LEN to support clinical and PWH decisions and medical management. The RESONATE RFP Program is in addition to Gilead’s existing Investigator Sponsored Research Program. Both programs support investigator-sponsored and collaborative research conducted by clinicians and researchers on Gilead's marketed products and/or within therapeutic areas of interest to the company.

Through the RESONATE RFP Program, Gilead will evaluate and potentially support research proposals which address one or more of the following topic areas:

  1. Engagement strategies or tactics, including innovative approaches to the utilization of B/F/TAF, that improve HIV care and patient reported outcomes in PWH (especially those facing challenges or barriers to sustained engagement in care)

    LOIs in this topic area should address at least one of the following open research questions:

    • What are innovative approaches to and the impact of the utilization of B/F/TAF in rapid (same day) re-start in PWH experiencing an interruption in care, including persistence and virologic outcomes post re-start?
    • What are effective interventions to limit stigma experienced by PWH in healthcare settings that improve access and sustained consistent engagement in HIV care?
    • What are novel interventions to improve HIV testing and linkage to care with rapid/immediate (same day) B/F/TAF initiation in key populations?
    • Key populations are those experiencing challenges with engagement in care such as individuals with pre-existing resistance, immigrants/migrants, homeless/marginally housed, those with substance use disorders, transgender women, youth, and those with mental health challenges
  2. Determining the effectiveness, safety, and/or persistence of B/F/TAF in populations facing barriers to access, adherence, and/or quality of care
    • Examples of such populations are those with pre-existing resistance, immigrants/migrants, homeless/marginally housed, those with substance use disorders, transgender women, youth, and those with mental health challenges
  3. Effectiveness, safety and adherence/persistence of LEN for HTE individuals in real world settings

    LOIs in this topic area should address at least one of the following open research questions:

    • What is the real-world effectiveness and safety of LEN + optimized background regimen (OBR) in HTE PWH?
    • What is the real-world adherence/persistence of LEN and the OBR among HTE PWH?
    • How does adherence/persistence of LEN compare to adherence/persistence of other HTE treatment options (i.e., ibalizumab, fostemsavir, enfuvirtide)?
  4. Drivers and barriers for implementation of LEN for HTE PWH

    LOIs in this topic area should address at least one of the following open research questions:

  • What challenges exist to implementing LEN for HTE PWH, and how can these be overcome?
  • Are there facilitators/best practices to implementing LEN for HTE PWH, and how can these be maximized?
  • What is the patient and provider experience when receiving treatment with LEN?
  • What actions or currently available tools could facilitate adherence to the OBR for HTE PWH receiving LEN?

Please discuss other research topics not listed above with your local Gilead Medical Scientist.

 

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