Impact of the Proposed Cuts to HIV/AIDS Research. Kevin Fisher AVAC September 7, 2017

Transcription

1 Impact of the Proposed Cuts to HIV/AIDS Research Kevin Fisher AVAC September 7, 2017

2 President s FY18 Budget Cuts $544 m from the FY 2017 NIH HIV/AIDS research budget levels A cut of 18.5% FY 18 Cut FY 18 HIV Research Funding

3 Real dollar impact of $554 m cut

4 What would cut do to researchers? No or very few new NIH research grants in FY 18. Disparate impact on early stage investigators with shorter grant terms. Lower further of grant success rate (currently 19% for NIAID grants) in future years. Interrupt science progress and careers, and reduce collaboration.

5 What priorities would that cut affect? These cuts target the five NIH high-priority areas of HIV/AIDS research: Research to reduce the incidence of HIV/AIDS, including the development of a vaccine (16.2% cut) Research to develop the next generation of HIV therapies (21.9% Cut) Research to develop a cure for HIV/AIDS (9.3% Cut) Research to improve prevention or treatment of HIVassociated comorbidities and co-infections (18.0% Cut) Research to support cross-cutting areas of basic research, health disparities, and training (22.6% Cut)

6 What is the HIV research need? For FY 17, the OAR By-Pass budget estimate of scientific need was $3.225 billion, a 7.5% increase. 10.5% increase to research to reduce incidence 8.9% increase to cure research 5.6% increase to basic research and reducing health disparities. The Presidents Budget is an approximately 25% less than OAR s estimated scientific need.

7 Don t Cut the NIH They re Busy. Prevention: Conducting clinical trials for vaccines, microbicides, Multi-Purpose Technologies, PrEP, and other biomedical prevention modalities. Health Disparities: Developing tools to address atrisk communities to reduce HIV/AIDS and health outcomes for PLWHA in different populations and cultural settings such as the South.

8 Don t Cut the NIH They re Busy. Cure: Identifying novel interventions, including therapeutic vaccines and next-generation monoclonal antibodies and derivatives to prevent the establishment of viral reservoirs and their elimination. Treatment: Developing and testing existing and novel agents to maximize viral suppression and adherence to prevent and treat HIV.

9 Don t Cut the NIH They re Busy. Co-Morbidities: Elucidating the mechanisms responsible for the pathogenesis of comorbid conditions of PLWHA, and developing interventions to treat and reduce, the risk of acquiring HIV-associated coinfections in diverse populations.

10 Percolating Prevention Pipeline Strategy Trial # Population Status Location PrEP Status Oral PrEP: Daily oral F/TAF bnab: VRC01 infused every 2 months Vax: ALVAC/gp120 MF59 adjuvant boost, 5 doses in 12 months Long-acting injectable: cabotegravir every two months HC/HIV: evaluating 3 contraceptives for possible increased risk Vax: Ad26/Mosaic + gp140 boost, 4 doses in 12 months Ring/PrEP: dapivirine ring and oral TDF/FTC Discover 5,000 MSM & transgender HVTN 704/ HPTN 085 HVTN 703/ HPTN 081 2,700 MSM & transgender 1,500 Sexually HVTN 702 5,400 Sexually & men HPTN 083 4,500 MSM & transgender HPTN 084 3,200 Sexually ECHO 7,800 Sexually HPX2008/ HVTN705 MTN 034/IPM 045/REACH 2,600 Sexually 300 Sexually Fully enrolled Enrolling Enrolling Enrolling Enrolling Planned start late 2017 Enrolling Planned start late 2017 Planned start late 2017 Canada, Denmark, Germany, Ireland, Italy, Netherlands, Spain, UK, US Brazil, Peru, Switzerland, US Botswana, Kenya, Malawi, Mozambique, Tanzania, South Africa, Zimbabwe South Africa Brazil, Peru, South Africa, Thailand, US Botswana, Kenya, Malawi, South Africa, Swaziland, Uganda, Zimbabwe Kenya, South Africa, Swaziland, Zambia Malawi, Mozambique, South Africa, Zambia, Zimbabwe Kenya, South Africa, Uganda, Zimbabwe Oral TDF/FTC as part of active control in doubledummy, double-blind design Access to oral FTC/TDF PrEP offered at no drug cost to every participant Oral TDF/FTC discussed in IC, risk reduction counseling sessions, and referral systems Oral TDF/FTC as part of active control in doubledummy, double-blind design Participants interested in oral TDF/FTC referred as programs become available in each study community TBD Open-label cross-over; all will try both ring and oral, then choose

11 Thank You!