Request for Novel HIV Research Applications Utilizing B/F/TAF
Through Medical Affairs, Gilead supports the research efforts of academic institutions, clinical investigators, and research networks to help improve initiation and long-term management of antiretroviral therapy (ART) for HIV-infected patients.
Gilead supports these research efforts where it has a legitimate scientific purpose. Gilead’s decision to support will be based on the validity of the scientific question proposed to be addressed, and only when the data that will be generated by the research proposal will complement the existing body of evidence and not repeat previous research studies.
Gilead is now making a specific call for proposals in the disease area of HIV. This Request for Applications (RFA) is in addition to the already existing Investigator Sponsored Research Program, which supports investigator-sponsored research conducted by clinicians and researchers on Gilead's marketed products or within therapeutic areas of interest to the company (https://www.gilead.com/science-and-medicine/research/investigator-sponsored-research).
With this RFA, Gilead intends to support investigator research focused on (i) addressing the challenges associated with rapid initiation of treatment upon a positive HIV infection diagnosis, for the reasons explained below; and (ii) treatment in populations that to date have been under-represented in clinical studies. Targeting reduction in new HIV infections through earlier initiation of ART and inclusion of special populations with evaluation of the potential barriers, and methods to overcome those barriers, will be positive steps towards achieving the UNAIDS 90:90:90 goal.
Please discuss other research topics not listed above with your local Medical Scientist.
Through the Medical Affairs Investigator Sponsored Research process, Gilead will evaluate and support programs which address the following two objectives:
- Rapid ART initiation1 with B/F/TAF
- Use of B/F/TAF in special HIV-infected populations that traditionally have been excluded from or under-recruited in clinical trial participation
1. Rapid ART Initiation with B/F/TAF
The benefits of earlier ART initiation have been demonstrated in 2 trials, START and TEMPRANO. The results of those trials are also supportive of rapid initiation. Advantages of rapid initiation include i) reducing the number of individuals who fail to engage in care between the time of HIV diagnosis and antiretroviral initiation; ii) decreasing the number of patients who are lost to follow-up; and iii) decreasing ongoing HIV transmission by reducing both the time to suppression and population viral load (compared to later initiation of therapy). The success of rapid ART initiation strategies, based on the studies, has led to adoption of rapid initiation in San Francisco and New York.
The goal of this objective is to evaluate rapid ART initiation programs (e.g., <7 days from HIV diagnosis to ART initiation), including randomized clinical trials, implementation science projects, studies of feasibility, participant acceptance of rapid start, modeling, and assessment of retention and viral suppression. Research studies may include, but are not limited to, the following elements:
- Occur within a defined population. A population may be defined by a clinic, a health system, a geographic location, demographics, or other clearly defined characteristics
- Define and evaluate novel methods of improving linkage from testing to care and the reduction in time to ART initiation
- Evaluate the percent of patients who are linked and retained in care and who achieve virologic suppression within the study time frame
- Evaluate individuals who do not initiate rapid ART and the reasons for exclusion/refusal (individual, structural, institutional)
- Define and evaluate HIV treatment outcomes, including maintenance of HIV suppression, tolerability, and persistence on therapy
2. Special Populations
The goal of this objective is to generate new or confirmatory clinical data on B/F/TAF efficacy and safety in special population patients, including, but not limited to:
- Patients who are ≥ 60 years old
- Patients with potential drug-drug interactions
- Patients with multiple co-morbidities
Items to consider in development of the proposal submission:
- The proposal should have clear scientific objectives based on scientific hypotheses
- Potential scalability and sustainability of the program once funding is complete; generalizability to other practice settings
- Defined and specific data collection methods
- Appropriate metrics
- Can be completed within 3 years
- For U.S.-based investigators, special consideration will be given to projects in the southern U.S. (Texas, Oklahoma, Louisiana, Mississippi, Alabama, Tennessee, Kentucky, Virginia, Washington, D.C., Maryland, Delaware, North Carolina, South Carolina, Georgia, Florida, Arkansas; see Gilead COMPASS Initiative at http://www.gilead.com/responsibility/compass)
- Proposals with the potential for rapid data dissemination and presentation of results will be prioritized
- Plan to publish results in peer-reviewed journals and to present results in scientific forums and to other organizations
Key Dates & Program Specifics
Letter of Intent (LOI): 2-page concise overview of proposed project and draft budget
15 March 2019: LOI submission window opens
10 May 2019: LOI submission window closes
The LOI should use the format attached to this document and should be submitted to firstname.lastname@example.org
Full Application Submission
A review of the LOIs will result in invitations for selected LOI applicants to submit a full application. The timelines below will be followed for those full submissions.
21 June 2019: Notice of LOI outcome, with invitations for full application submission
2 August 2019: Deadline for receipt of full application
Early to mid-September 2019: Notice of full application outcome
Investigators who meet criteria for a standard Gilead ISR (https://www.gilead.com/science-and-medicine/research/investigator-sponsored-research) are encouraged to apply. There are no geographic limitations for applications.
The program provides awards for proposals completed in up to 3 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 $5,000,000 in funds for these research proposals, dependent upon availability of funds and receipt of meritorious applications. Gilead anticipates that 6-10 awards will be granted. Any proposal greater than $500,000 should be discussed with your Gilead Medical Scientist prior to submission.
Proposals which request B/F/TAF study medication will also be considered, but supply will be dependent on the status of local approval for supply of the particular study medication.
Once notice of approval to submit a full application has been received, a full application should be submitted according to the instructions at https://www.gilead.com/science-and-medicine/research/investigator-sponsored-research. Questions about the announcement or application process should be submitted to your local Medical Scientist.
Gilead reserves the right to approve or decline any application. Applications are reviewed by an internal review committee.
LOI will be rigorously reviewed by an internal (Gilead) 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 RFA, the potential impact of the study, the strength of the objectives/study design, and the 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.
About Gilead Sciences: Gilead Sciences, Inc. is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.
1. As defined by the World Health Organization: “Rapid initiation is defined as within seven days from the day of HIV diagnosis.” WHO Guidelines for managing advanced HIV disease and rapid initiation of antiretroviral therapy. http://www.who.int/hiv/pub/guidelines/advanced-HIV-disease/en