CROI 2015 Program and Abstracts

Abstract Listing

Oral Abstracts

Conclusions: Home HTC can strengthen linkage to care and enhance the increases in ART uptake that will result from South Africa’s expanding ART eligibility criteria. As treatment programs move forward to implement ‘90% of HIV-infected persons tested, 90% treated, 90% achieving viral load suppression’, insights from this analysis find that community- based HTC and linkage is a cost-effective strategy for HIV prevention. 1114 Global Fund Cost Projections for ImplementingWHO 2013 Guidelines Obinna Onyekwena ; Ade Fakoya; Michael Johnson; Michael Olszak-Olszewski; Mark Dybul The Global Fund to Fight AIDS, Tuberculosis and Malaria, Geneva, Switzerland Background: Although recent global cost estimates indicate overall investments needed for implementation of the World Health Organization 2013 consolidated ART guidelines, detailed financial estimates for individual countries are limited. The aim of this study was to estimate additional costs for the transition of Global Fund grants to implement ART eligibility recommendations of the new guidelines. Methods: The thirty-two countries which represent 83% of current Global Fund country allocations for HIV were included in the review. Data on treatment targets, ARV costs, and financing contributions to ARV were extracted from the Global Fund reporting database, grant documents and National AIDS Spending Assessment reports. Global projections for additional numbers of persons eligible for treatment, reported by WHO, were applied to country treatment targets to derive country-level number projections for 2015 to 2017. A weighted average ARV cost was used to determine associated ARV cost projections. Due to inter-program variability, facility and adherence support costs were not included. Treatment numbers and cost projections were disaggregated by new eligibility criteria and compared to current total allocations for HIV. Results: ARV medicine cost for 2014 Global Fund commitments in 32 countries was estimated to be $628 million for 5 million patients on antiretroviral treatment. Additional cost of ARV medicines expected from ART eligibility recommendations was projected to be US$695 million to the end of 2017, for an additional 1.7 million persons on treatment. Costs for implementation of Option B+ and treating all HIV positive children below the age of five were US$53 million and US$106 million respectively; while initiating HIV positive persons with a CD4 count between 350 and 500 cells per mm 3 and in serodiscordant relationships had estimated additional costs of US$294 million and US$242 million respectively. The total ARV medicine cost projections represented approximately 41% (US$2.6 billion) of the total HIV allocations projected from 2015 to 2017 for the 32 countries analysed. Conclusions: ARV medicine scale up costs alone will account for a significant portion of HIV resources allocated by the Global Fund to national HIV programs. This does not take into account additional facility and adherence support costs needed for quality service delivery. Understanding differential cost data in the implementation of treatment guidelines should strengthen strategic investments and portfolio optimisation. 4:00 pm– 6:15 pm New Antiretroviral Agents, Strategies, and HIV Drug Resistance 113LB Tenofovir Alafenamide (TAF) in a Single-Tablet Regimen in Initial HIV-1 Therapy DavidWohl 1 ; Anton Pozniak 2 ; MelanieThompson 3 ; Edwin DeJesus 4 ; Daniel Podzamczer 5 ; Jean-Michel Molina 6 ; Gordon Crofoot 7 ; Christian Callebaut 8 ; Hal Martin 8 ; Scott McCallister 8 1 University of North Carolina, Chapel Hill, NC, US; 2 Chelsea and Westminster Hospital, NHS Foundation Trust, London, United Kingdom; 3 AIDS Research Consortium of Atlanta, Atlanta, GA, US; 4 Orlando Immunology Center, Orlando, FL, US; 5 Hospital Universitari de Bellvitge, Barcelona, Spain; 6 Hopital Saint Louis, Paris, France; 7 Gordon Crofoot Research, Houston, TX, US; 8 Gilead Sciences, Inc, Foster City, CA, US; 9 Gilead Sciences, Inc, Foster City, CA, US Background: Tenofovir alafenamide (TAF) is a novel tenofovir (TFV) prodrug that, when administered in the single tablet regimen elvitegravir/cobicistat/emtricitabine/TAF (E/C/F/ TAF), has >4-fold increase in intracellular TFV diphosphate and >90% lower plasma TFV levels compared to tenofovir disoproxil fumarate (TDF). Two Phase 3 studies of identical design were conducted in distinct geographic areas comparing 2 single tablet regimens, E/C/F/TAF and E/C/F/TDF, in treatment-naïve HIV-1 + adults. Methods: Patients were randomized 1:1 to receive a single tablet regimen of E/C/F/TAF or E/C/F/TDF once daily in two Phase 3 double blind studies. Primary endpoint was Week 48 virologic response by FDA Snapshot algorithm in a pre-specified analysis of the combined studies. Results: 1,733 subjects were randomized and treated: 15%women, 43% non-White, 23% viral load ≥ 100,000 copies/mL. Median baseline characteristics were: age 34 yrs, VL 4.58 log 10 c/mL, and CD4 count 427 cells/ m L. The primary objective was met, as E/C/F/TAF was non-inferior to E/C/F/TDF with 92% and 90%, respectively, having HIV RNA <50 copies/mL at week 48 (difference +2%, 95% CI -0.7% to +4.7%, p=0.13). The rates of virologic success between E/C/F/TAF and E/C/F/TDF were similar across subgroups according to age, sex, race, baseline HIV1 RNA level, baseline CD4 cell count, region (US versus exUS), and study drug adherence. Mean change in CD4 count at Week 48 was 230 cells/ m L in the E/C/F/TAF arm vs. 211 cells/ m L for E/C/F/TDF (p=0.02). Virologic failure with resistance occurred in 0.8% in the E/C/F/TAF arm and 0.6% on E/C/F/TDF. Treatment related SAEs were rare: E/C/F/ TAF 0.3% (n=3), E/C/F/TDF 0.2% (n=2). There were no reports of proximal renal tubulopathy (including Fanconi Syndrome) in either arm. No single AE led to discontinuation of more than 1 subject on E/C/F/TAF. Grade 2, 3, or 4 AEs occurring in ≥ 2%were: diarrhea (3.3% vs. 2.5%), nausea (2.2% vs. 2.0%), headache (2.9% vs. 2.1%), and URI (3.6% vs. 3.1%) in the E/C/F/TAF and E/C/F/TDF arms, respectively. Session O-10 Oral Abstracts Room 6C

Oral Abstracts

Conclusions: Through 48 weeks of treatment, high virologic response rates were seen in patients receiving E/C/F/TAF or E/C/F/TDF, and similar responses were seen across subgroups evaluated. Drug resistance was <1%. Both regimens were well tolerated, and no unique AEs associated with TAF occurred. These data support the use of E/C/F/TAF, the first TAF-based single tablet regimen, as a potential new regimen for initial treatment of patients with HIV-1 infection.

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CROI 2015