BRAVVO RFP Program
BRAVVO RFP Program
(Biktarvy® Research to AdVance HIV Outcomes)
Gilead supports the research efforts of academic institutions, clinical investigators and research networks to help improve long-term care and management for people living with HIV.
Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF*) is a complete HIV-1 treatment for adults and children with HIV who weigh at least 55 pounds 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 living with HIV and offers a high barrier to resistance and few interactions with other drugs. However, further scientific data related to the real-world use of B/F/TAF are needed in medical literature to continue building out the medicine’s clinical profile.
Gilead is making a specific request for research study proposals in the disease area of HIV. The BRAVVO RFP Program is in addition to Gilead’s existing Investigator Sponsored Research Grant Program. Both programs support investigator-sponsored research conducted by clinicians and researchers on Gilead's marketed products and/or within therapeutic areas of interest to the company.
Through the BRAVVO RFP Program, Gilead will evaluate and potentially support programs which address the following topic areas:
1. Resistance Barrier and Regimen ‘Forgiveness’
- Does B/F/TAF have a higher resistance barrier in clinical studies or real-world settings than dolutegravir/lamivudine (DTG/3TC) and/or dolutegravir/rilpivirine (DTG/RPV)?
- Is there less treatment-emergent resistance in patients taking B/F/TAF compared to DTG/3TC or DTG/RPV?
- Is B/F/TAF more forgiving than DTG/3TC or DTG/RPV ART regimens in difficult-to-treat or adherence-challenged populations? (Regimen forgiveness can be considered the ability of the regimen to still maintain viral suppression in the setting of less-than-optimal adherence despite daily dosing.)
- Are there populations in which B/F/TAF has more sustained viral suppression versus DTG/3TC or DTG/RPV?
2. Weight-Change Mechanisms and Clinical Implications
- What are the mechanisms, including genetic predictors, of weight gain and/or suppression in people living with HIV who are on antiretroviral therapy (ART) (e.g., TDF, TAF vs TDF, INSTIs vs non-INSTIs)?
- What differentiates those with greater weight gain who are on antiretrovirals (ARVs), including TAF- and/or INSTI-based regimens, from other people living with HIV?
- What are the clinical and clinical practice implications of weight change in people living with HIV on ART, including the impact on metabolic syndrome (e.g. impact on lipids, cardiovascular events, diabetes, frequency of needed lab testing, etc.)?
- Is weight gain on ARVs different than that in the matched general population?
3. Cabotegravir + Rilpivirine Long-Acting Intramuscular to B/F/TAF Switch
What is the impact, including healthcare resource utilization, costs and patient-reported outcomes, of switching patients from a cabotegravir + rilpivirine long-acting intramuscular regimen to B/F/TAF?
4. Safety in Pregnancy
What innovative methodologies, interventions or implementation science projects can be used to increase reporting to a registry that monitors pregnancy outcomes in women exposed to B/F/TAF during pregnancy? Healthcare providers are encouraged to register patients who are exposed to B/F/TAF during pregnancy by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263.
5. Rapid Start in Late Presenters
What are the effectiveness and clinical outcomes of B/F/TAF for late presenters using a rapid-start approach in resource-limited settings?
Please discuss other research topics not listed above with your local Gilead Medical Scientist.
Application CriteriaWe recommend that submitted proposals:
- Have clear scientific objectives based on scientific hypotheses
- Note potential scalability and sustainability of the program once funding is complete (when applicable)
- Highlight generalizability to other practice settings
- Define specific data collection methods
- Collect appropriate metrics
- Can be completed within three years
- Have the potential for rapid data dissemination and presentation of results (such proposals will be prioritized)
- Outline plans to publish results in peer-reviewed journals, and to present results in scientific forums and to other organizations
Submission Deadlines and Application Process
Letter of Intent Submission Window
- May 3, 2021: Submission window opens
- June 7, 2021 (23:59 UTC): Submission window closes
Letters of Intent (LOIs) must be submitted via the Gilead OPTICS online portal.
Questions about the announcement or the application process can be submitted to your local Gilead Medical Scientist or BRAVVO@gilead.com
Full Application Submission
A review of the LOIs will result in invitations for selected LOI applicants to submit a full application, including a complete proposal with detailed budget. Below are the timelines for full submissions.
- July 5, 2021: Notice of LOI outcome, with invitations for full application submission
- Aug. 2, 2021 (23:59 UTC): Deadline for receipt of full application
- Mid-September 2021: Notice of full application outcome
Applications must be completed in Gilead OPTICS following approval to submit.
Investigators who meet criteria for a standard Gilead ISR are encouraged to apply. There are no geographic limitations to applications.
The program provides awards for proposals completed in up to three years. Awards shall be for research purposes only. Requests that include routine medical care or other costs associated with routine medical care will not be considered.
Gilead plans to award a total of approximately $5 million in funds for these research proposals, dependent upon availability of funds and receipt of meritorious applications. Gilead anticipates that six to 10 awards will be granted. Any proposal greater than $500,000 should be discussed with your Gilead Medical Scientist prior to submission.
LOIs will be rigorously reviewed by a Gilead internal committee. Each LOI that meets program requirements and is complete will be assigned to multiple primary and secondary 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 and study design and the sustainability and scalability of the methods under study. Scoring is based on the modified NIH Scoring Tool. High-scoring LOIs will be discussed by a multi-disciplinary committee. Investigators with the top LOI submissions will be offered the opportunity to submit a full proposal, which will be similarly reviewed.
Gilead reserves the right to approve or decline any application. Submission of an LOI or an application does not guarantee funding. Applications are reviewed by an internal review committee.
*B/F/TAF refers to Gilead’s Biktarvy® (bictegravir 50 mg / emtricitabine 200 mg / tenofovir alafenamide 25 mg tablets).