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Andrea Ciaranello, MD, MPH Kenneth A. Freedberg, MD, MSc Jennifer Chu, BS Shahin Lockman, MD, MSc

Lopinavir/ritonavir- compared to nevirapine-based ART following exposure to single-dose nevirapine in South Africa: A cost-effectiveness analysis of the ACTG 5208/ OCTANE trial. Andrea Ciaranello, MD, MPH Kenneth A. Freedberg, MD, MSc Jennifer Chu, BS Shahin Lockman, MD, MSc

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Andrea Ciaranello, MD, MPH Kenneth A. Freedberg, MD, MSc Jennifer Chu, BS Shahin Lockman, MD, MSc

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  1. Lopinavir/ritonavir- compared to nevirapine-based ART following exposure to single-dose nevirapine in South Africa: A cost-effectiveness analysis of the ACTG 5208/ OCTANE trial Andrea Ciaranello, MD, MPH Kenneth A. Freedberg, MD, MSc Jennifer Chu, BS Shahin Lockman, MD, MSc Michael Hughes, PhD Judith Currier, MD Charles Holmes, MD, MPH James McIntyre, MBChB, FRCOG Elena Losina, PhD Rochelle P. Walensky, MD, MPH Supported by NIAID, ACTG, & Doris Duke Charitable Foundation

  2. Background • Single-dose nevirapine (sdNVP) widely used for prevention of mother-to-child HIV transmission • Resistance to NNRTIs may reduce effectiveness of later NNRTI-based ART • ACTG A5208/OCTANE trial: • LPV/r- vs. NVP-based ART after sdNVP exposure • LPV/r: lower rates of virologic failure or death • LPV/r is 12 times more expensive than NVP

  3. Objective • To determine the cost-effectiveness of LPV/r-based ART compared to NVP-based ART for women with prior sdNVP exposure in South Africa

  4. Cost-effectiveness of Preventing AIDS Complications (CEPAC) –International Model • Widely published computer simulation model of HIV disease • Opportunistic diseases, CD4, HIV RNA, ART efficacy • Data from the OCTANE trial and other published cohorts in South Africa • Cape Town AIDS Cohort • Projected 2-year and lifetime outcomes: • Opportunistic disease, survival • Per-person HIV-related costs

  5. Cost-effectiveness analysis • Compare alternative health care strategies • Incremental CE ratio (ICER): Additional Resource Use $ Additional Health Benefit Year of life saved (YLS) • Lower ratio = more cost-effective • WHO: Compare ICER to per-capita GDP • ICER < 1 X GDP / YLS: “very cost-effective” • ICER < 3 X GDP / YLS: “cost-effective” • South Africa GDP (2006): 5,400 USD in

  6. Strategies examined • No ART (for comparison) • 1st-line NVP, 2nd-line LPV/r • 1st-line LPV/r, 2nd-line NVP • Lifelong LPV/r and 3TC after failure of 2nd line • Tenofovir / emtricabine in 1st-line ART • Zidovudine / didanosine in 2nd-line ART

  7. OCTANE: Baselinecohort characteristics

  8. ART efficacy • No HIV RNA monitoring • ART switched for severe opportunistic disease, 50% CD4 decline, or toxicity *Murphy, CROI 2009 #658; Asboe, HIV Clin Trials 2003; Castelnuovo, JIAPAC 2009; Hosseinipour, CROI 2009 #605; Fox, CROI 2009 #606

  9. Costs (2006 USD) • HIV-related health care costs • South African Health Systems Trust • Hospital day = $221 • Outpatient visit = $11 • CD4 assay = $9 / test • Yearly drug costs • Clinton Foundation HIV/AIDS Initiative

  10. Results: Projected 2-year outcomes (# per person) • 1st-line LPV/r compared to 1st-line NVP: • 26% relative risk reduction in mortality • Additional per-person cost of $330

  11. Results: Projected long-term outcomes * WHO threshold: $5,400 / YLS = 1x South Africa GDP

  12. OCTANE subgroups • No NNRTI resistance at baseline • 86% of OCTANE cohort • 1st-line LPV/r no longer “very cost-effective” ($10,990/YLS) • Time from sdNVP to ART initiation • 6-24m: 1st-line LPV/r “very cost-effective” ($2,000/YLS) • >24m: ICER at WHO threshold ($5,400/YLS) • 1st-line LPV/r less cost-effective as time from sdNVP increases

  13. Sensitivity analyses • 2nd-line NVP efficacy • Few data: 16-45%*; range evaluated 0-100% • 1st-line LPV/r “very cost-effective” unless 2nd-line NVP efficacy ≤ 15% • No impact on policy conclusions: • Availability of HIV RNA monitoring • Presence or absence of 3rd-line ART • Cost of LPV/r (range: $0 - $972 / year) * Murphy, CROI 2009 #658; Asboe, HIV Clin Trials 2003

  14. Limitations • Some model input parameters from cohort of both men and women • Costs and cost-effectiveness thresholds specific to South Africa • Results sensitive to data not yet available from OCTANE trial • Outcomes of 2nd-line ART

  15. Conclusions • Among women similar to OCTANE participants (sdNVP median 17 months prior) in South Africa, 1st-line LPV/r improves survival and is very cost-effective, compared to 1st-line NVP • Findings are robust to variations in monitoring strategies, 3rd-line ART, and LPV/r costs • 1st-line LPV/r may not be very cost-effective if: • Efficacy of NVP in 2nd-line ART is low • NNRTI resistance is not detected at baseline • Time from sdNVP to ART initiation is >24 months

  16. Acknowledgments A5208/OCTANE team Judith Currier Michael Hughes Shahin Lockman James McIntyre Evelyn Zheng CEPAC Collaborators (South Africa) Linda-Gail Bekker Glenda Gray Neil A. Martinson Lerato Mohapi Robin Wood CEPAC (MGH, HSPH, Yale, Cornell) David Paltiel Mai Pho Mary Pisculli Erin Rhode Paul Sax Callie Scott George Seage Bruce Shackman Caroline Sloan Heather Smith Adam Stoler Lauren Uhler Bingxia Wang Rochelle Walensky Milton Weinstein Yazdan Yazdanpanah Ingrid Bassett Melissa Bender John Chiosi Jennifer Chu Sarah Chung Kara Cotich Kenneth Freedberg Sue Goldie Charles Holmes April Kimmel Julie Levison Elena Losina Benjamin Linas Zhigang Lu Bethany Morris Brandon Morris Supported by: ACTG, NIAID, Doris Duke Charitable Foundation

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