RESONATE RFP Program

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.

Submission Deadlines and Application Process

Letter of Intent Submission Window

To apply for consideration for funding under the RESONATE RFP Program, you will need to submit a Letter of Intent (LOI) that is no longer than two pages, contains a concise overview of the proposed project and includes the total estimated budget.

• July 10, 2023: Submission window opens
• September 15, 2023 (23:59 PST): Submission window closes

LOIs must be submitted via the Gilead Optics online portal in the RESONATE LOI section in order to be considered for this program.

 

Gilead will evaluate and rank all letters of intent (LOI) received on a rolling basis until funds are exhausted. It is recommended to submit earlier rather than later so your proposal can be evaluated while funding is still available.

Questions about the RFP or the application process can be submitted to your local Gilead Medical Scientist or RESONATE@gilead.com

 

A review of the LOIs will result in invitations for selected LOI applicants to submit a full application with detailed budget. Below are the timelines for full submissions.

• By October 2, 2023: Notice of LOI outcome, with invitations for full application submission
• By November 1, 2023 (23:59 PST): Deadline for receipt of full application
• By December 8, 2023: Notice of full application outcome

Applications must be completed in Gilead Optics following invitations to submit full proposals.

 

Budget Considerations

Gilead plans to award up to $5,000,000 in funds for these research proposals, dependent upon availability of funds and receipt of meritorious applications. Gilead anticipates that up to 10 awards will be granted. Any proposal greater than $500,000 should be discussed with your Gilead Medical Scientist prior to submission.

 

Review Process

LOIs will be rigorously reviewed by an internal Gilead committee. Each LOI that meets program requirements and is complete, will be assigned to multiple reviewers. Each reviewer will review and score the LOI and will evaluate how well the proposal addresses the RFP, the potential impact of the study, the strength of the objectives/study design and sustainability/scalability of the methods under study. Scoring is based on the modified NIH Scoring Tool. High scoring LOIs will be discussed by a multidisciplinary committee. Investigators with the top LOI submissions will be offered the opportunity to submit a full proposal, which will be similarly reviewed.

 

No Guarantee of Funding

Gilead reserves the right to approve or decline any application at its sole discretion. Submission of an LOI or a full application does not guarantee funding.

 

No Inducement or Reward

Gilead approval of awards does not take into account the past, present, or future volume or value of any business or referrals between the parties. Awards are not being given, directly or indirectly, as an inducement or reward with respect to the past or potential future purchase, utilization, recommendation or formulary placement of any Gilead product. Furthermore, except for the use of the Gilead product in an approved award/research, the awardee is not required to purchase, order, recommend or prescribe to any patients any products manufactured by or available through Gilead.

 

*B/F/TAF refers to Gilead’s Biktarvy® (either bictegravir 50 mg / emtricitabine 200 mg / tenofovir alafenamide 25 mg tablets for adult and pediatric patients weighing ≥25kg or bictegravir 30 mg / emtricitabine 120 mg / tenofovir alafenamide 15 mg tablets for pediatric patients weighing ≥14 kg to <25 kg)