CROI 2020 Abstract eBook

Abstract eBook

Poster Abstracts

Results were robust to alternative time horizons and PrEP-using population sizes; regardless of age and F/TDF costs, the maximum justifiable markup over generic F/TDF was <$750/yr. Using the entire US HIV prevention budget ($900.8M) and base case assumptions of F/TAF and F/TDF costs, 54,270 people could receive F/TAF and 105,210 could receive F/TDF annually; this difference in PrEP coverage would result in an additional 8,610 new HIV infections with F/TAF. Conclusion: Given its minimal impact on adverse events, F/TAF justifies a markup no greater than $750 over generic F/TDF in the US. At a higher price, it may well do more harm than good.

1 Kheth’Impilo AIDS Free Living, Cape Town, South Africa, 2 University of the Witwatersrand, Johannesburg, South Africa, 3 University of California Los Angeles, Los Angeles, CA, USA, 4 Ministry of Health and Child Care, Harare, Zimbabwe Background: Multimonth dispensing (MMD) of antiretroviral treatment (ART) is a differentiated service delivery model aiming to reduce patient-related barriers to care and improve health system efficiency in low-income settings. There is increased interest in MMD models, however, randomized evidence of its clinical effectiveness is lacking. We performed a cluster-randomized trial comparing three and six-monthly MMD in community-based ART refill groups (CARGs) versus standard-of-care facility-based ART delivery in Zimbabwe. Methods: A three-arm, unblinded, pragmatic cluster-randomized, non- inferiority trial. Thirty healthcare facilities (clusters) and linked CARGs were allocated to either: ART collected three-monthly at facility (3MF, control); ART provided three-monthly in CARGs (3MC); or ART provided six-monthly in CARGs (6MC). Stable adults receiving ART ≥six months with baseline viral load (VL) <1000 copies/ml were enrolled. Retention in ART care (primary outcome) and viral suppression (VS) 12 months after enrolment were compared by arm, using regression models specified for clustering. ClinicalTrials.gov, NCT03238846. Results: 4800 participants were enrolled; 1919, 1335 and 1546 in 3MF, 3MC and 6MC, respectively. Retention was high and similar in all arms, 93.0%, 94.8% and 95.5% in 3MF, 3MC and 6MC, respectively (table). The pre-specified non-inferiority limit (-3.25%, risk difference [RD]) was met for comparisons between all arms; 3MC vs. 3MF, adjusted RD=1.1% (95% CI: -0.5% to 2.8%); 6MC vs. 3MF: aRD=1.2% (CI: -1.0% to 3.6%); and 6MC vs. 3MC: aRD=0.1% (CI: -2.4% to 2.6%). VL completion at 12 months was 49%, 45% and 8% in 3MF, 3MC and 6MC, respectively.VS in 3MC (99.7%) was high and not different to 3MF (99.1%), relative risk=1.0 (CI: 1.0-1.0). VS was marginally reduced in 6MC (92.9%) vs. 3MF, relative risk=0.9 (CI: 0.9-1.0). Conclusion: Retention in CARGs receiving three and six-monthly MMD was noninferior to standard-of-care facility-based ART delivery in Zimbabwe for stable patients, and is a strategy that can be scaled-up. VS in six-monthly CARGs requires further evaluation. Rochelle P. Walensky 1 , Tim Horn 2 , Nicole McCann 1 , Kenneth Freedberg 1 , A. David Paltiel 3 1 Massachusetts General Hospital, Boston, MA, USA, 2 National Alliance of State and Territorial AIDS Directors, Washington, DC, USA, 3 Yale University, New Haven, CT, USA Background: F/TAF is approved as a safer, non-inferior PrEP option compared with F/TDF. With generic F/TDF expected in 2020, we examine howmuch more payers should be willing to pay for the improved safety profile of branded F/TAF. Methods: We assembled safety data for F/TAF and F/TDF in an age-stratified population of 123,610 US MSMwithout HIV and from studies of people with HIV. Data were used to forecast fractures, ESRD cases, quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratios (ICERs) over 5y. To determine the maximum price differential for F/TAF (currently $16,600/year, Federal Supply Schedule) over generic F/TDF, we portrayed F/TAF as favorably as possible, ignoring any ASCVD effects and overstating its safety. For example, we assumed for those on F/TDF that: 1) severe loss of bone mineral density resulted in osteoporosis-related fractures and that all fractures occurred at the hip, leading to a one year 30% quality of life (QoL) decrement and a cost of $70,400; 2) background ESRD rates were more than double their reported value and ESRD was immediate and irreversible, resulting in a 47% QoL decrement and costs of $92,100-$95,500 each year; and 3) the generic F/TDF alternative would achieve a modest (50%) price reduction to $8,300/year. We also examined the budget impact of F/TDF vs. F/TAF, comparing PrEP coverage and transmissions. Results: Compared to F/TDF, F/TAF averted 2,101 fractures and 30 ESRD cases, the ICER exceeded $7 million/QALY gained (Table). At a willingness to pay of $100,000/QALY, the maximum justifiable price for F/TAF was $8,680/year. Even among patients at highest risk of fracture and ESRD (>55y), the ICER for F/TAF exceeded $3 million/QALY and the maximum justifiable price was $9,020/year.

1090 COST-EFFECTIVENESS OF POINT OF CARE VIRAL LOAD ADOPTION STRATEGIES IN SOUTH AFRICA

Sarah Girdwood 1 , Thomas Crompton 2 , Wendy Stevens 3 , Brooke E. Nichols 4 1 Health Economics and Epidemiology Research Office, Johannesburg, South Africa, 2 Right to Care, Johannesburg, South Africa, 3 National Health Laboratory Service, Johannesburg, South Africa, 4 Boston University, Boston, MA, USA Background: Viral load (VL) testing is the recommended method for monitoring HIV patients on ART. South Africa, through the National Health Laboratory Service (NHLS), currently operates a highly centralized VL network that conducted > 5 million VL tests in 2018 at 16 laboratories. Despite this wide network, the system faces challenges surrounding sample integrity, result delivery and clinical action delays. Recent evidence suggests that point of care (POC) instruments could improve patient retention/viral suppression. We assessed the cost-effectiveness of POC adoption strategies to improve patient outcomes. Methods: We developed a geospatial cost model utilizing existing data from NHLS, including geospatial data on facilities in South Africa who send blood samples to centralized laboratories for VL testing, their annual VL volume, suppression rates (<1000 copies/ml), sample rejection rates, turn-around time (TAT), and the cost per test. We assessed the impact of the adoption of two validated VL POC technologies (Cepheid GeneXpert and Abbott m-PIMA) under 4 scenarios: 1) status-quo (all centralized); 2) POC coverage at facilities with a combination of low suppression rates, and high rejection rates and TAT; 3) targeted POC just at facilities with low suppression rates; and 4) a complete switch from centralized to POC testing. For each scenario and POC technology we determined the total cost, effectiveness (total expected number of people with suppressed VL) and incremental cost-effectiveness ratio (ICER) based on expected improvement in suppression rates from POC adoption. The effectiveness of POC VL in improving viral suppression was varied in a sensitivity analysis. Results: The centralized network costs $121m annually with a VL suppression rate of 85.2%. Scenario 3 (targeted testing) using the GeneXpert is considered highly cost-effective at $40 per additional person suppressed, compared to the centralized network. Should resources allow, the all-POC scenario using a mix of GeneXpert and m-PIMA may still be cost-effective with an ICER of $1,095 compared to Scenario 3, requiring an additional $52m annually. All other scenarios were dominated in the incremental analysis. When POC VL resulted in lower levels of viral suppression than expected, ICERs proportionally increased. Conclusion: Assuming POC confers patient benefits, the most cost-effective strategy for POC adoption in South Africa is likely to be a targeted approach, with POC placed at facilities with high rates of viral failure.

Poster Abstracts

1089LB F/TAF VS F/TDF FOR PrEP: HOW MUCH IS “BETTER”WORTH?

CROI 2020 410