Update on BHP TasP Trials. Presentation by : Dr Joseph Makhema CEO BHP

Transcription

1 Update on BHP TasP Trials Presentation by : Dr Joseph Makhema CEO BHP

2 } Botswana has the second highest HIV prevalence rate 19% BIAS IV } Highest rates in Africa for indicators of progress, such as 55% coverage routine and voluntary testing and counseling the highest fraction of AIDS patients who receive ART (> 90%) the highest fraction of HIV-positive pregnant women tested with chemoprophylaxis to reduce MTCT (>96%) } new annual HIV infections declining by 71 percent between 2001 and 2011

3 225, , , , ,000 Number of patients 100,000 75,000 50,000 25,000 Currently on HAART in Public Sector Cumulative deaths Currently on HAART and Outsourced to Private Sector Jan/02 Apr/02 Jul/02 Oct/02 Jan/03 Apr/03 Jul/03 Oct/03 Jan/04 Apr/04 Jul/04 Oct/04 Jan/05 Apr/05 Jul/05 Oct/05 Jan/06 Apr/06 Jul/06 Oct/06 Jan/07 Apr/07 Jul/07 Oct/07 Jan/08 Apr/08 Jul/08 Oct/08 Jan/09 Apr/09 Jul/09 Oct/09 Jan/10 Apr/10 Jul/10 Oct/10 Jan/11 Apr/11 Jul/11 Oct/11 Jan/12 Apr/12 Jul/12 Oct/12 Jan/13 Apr/13 Jul/13 Oct/13 Jan/14 0 Month / Year

4 Botswana ANC Prevalence and Trends

5 } Estimated from various sources UNAIDS EPP/Spectrum (general population year Incidence Assays based cross sectional studies in BAIS III and IV Monitoring the changes in prevalence in age-groups years Special studies [Longitudinal follow-up in MPP] Trend reduction of Incidence. Estimated at 1.17 [95% CI ] in 2013 Estimated 1.35% in BAIS IV Mochudi Study 1.79%

6 New laboratory: opened December

7 Mashi PMTCT Tshepo AIDS Treatment Secure the Future Foundation Botsogo Cost Effectiveness Kgatelopele Long-Term Resistance ACHAP Mma Bana PMTCT Mpepu Infant Health Mochudi Project Community-Level Prevention Clinical Trials Unit Therapy/Prevention Tshedimoso Acute Infection Tshipidi Infant Health Thibelo Discordant Couple HAART Botswana Combination Prevention Project 30 Villages CDC Losika Genetic Risk Netefatso Acyclovir UW/Gates Foundation 18-7

8 Part I Does the addition of nevirapine to AZT further reduce MTCT? Part I modified: Is maternal NVP needed if all mothers received ZDV and their infants ZDV + NVP? } Part II Is 6 months of breastfeeding along with 6 months of prophylactic AZT to the baby a safe alternative to formula feeding? Sample size: 1200 Mother/infant pairs Funded PI Max Essex, Co-PI Ibou Thior

9 20: June 12, 2006 Maternal Single-Dose Nevirapine versus Placebo as Part of an Antiretroviral Strategy to Prevent Mother-to-Child HIV Transmission in Botswana Roger L. Shapiro, Ibou Thior, Peter B. Gilbert, Shahin Lockman, Carolyn Wester, Laura M. Smeaton, Lisa Stevens, S. Jody Heymann, Thumbi Ndung u, Simani Gaseitsiwe, Vladimir Novitsky, Joseph Makhema, Stephen Lagakos and Max Essex 296: August 16, 2006 Breastfeeding Plus Infant Zidovudine Prophylaxis for 6 Months vs Formula Feeding Plus Infant Zidovudine for 1 Month to Reduce Mother-to-Child HIV Transmission in Botswana A Randomized Trial: The Mashi Study Ibou Thior, Shahin Lockman, Laura M. Smeaton, Roger L. Shapiro, Carolyn Wester, S. Jody Heymann, Peter B. Gilbert, Lisa Stevens, Trevor Peter, Soyeon Kim, Erik van Widenfelt, Claire Moffat, Patrick Ndase, Peter Arimi, Poloko Kebaabetswe, Patson Mazonde, Joseph Makhema, Kenneth McIntosh, Vladimir Novitsky, Tun-Hou Lee, Richard Marlink, Stephen Lagakos and Max Essex, for the Mashi Study Team 356: January 11, 2007 Response to Antiretroviral Therapy after a Single, Peripartum Dose of Nevirapine Shahin Lockman, Roger L. Shapiro, Laura M. Smeaton, Carolyn Wester, Ibou Thior, Lisa Stevens, Fatima Chand, Joseph Makhema, Claire Moffat, Aida Asmelash, Patrick Ndase, Peter Arimi, Erik van Widenfelt, Loeto Mazhani, Vladimir Novitsky, Stephen Lagakos and 15-6 Max Essex

10 560 women with CD4 > 200 cells/mm 3 randomized to: Arm A vs. Arm B 170 women with CD4 < 200 cells/mm 3 or AIDS enrolled observationally: Obs Arm Antepartum (26-34 wks) Trizivir (Abacavir/AZT/3TC) Kaletra / Combivir (Lopinavair/ritonavir/AZT/3TC) Antepartum (18-34 wks) Nevirapine / Combivir (Nevirapine/AZT/3TC) Intrapartum (supplemental AZT) Intrapartum (supplemental AZT) Breastfeeding (6 months) (Rapid weaning before 6 mo visit) Breastfeeding (6 months) (Rapid weaning before 6 mo visit) HAART continued for treatment Followup (2 years) Followup (2 years) Infants received single-dose NVP at birth and AZT x 1 month

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13 } GOAL To demonstrate the feasibility and acceptability of a prevention package to reduce HIV incidence in Mochudi, a village with 37,000 people in southern Botswana with an HIV prevalence of 25% in adults } SPECIFIC AIMS Monitor incidence through repeated door-to-door HTC surveys Implement a prevention package including treatment of individuals with HVL irrespective of CD4, smc, PMTCT, behavioral messages Explore potential transmission clusters within Mochudi by using epidemiological data (partner notification) and viral genome signature tracing Develop mathematical models to identify comprehensive control strategies which capitalize on synergies among individual prevention measures Identification & Treatment of High Viral Load >50,000

14 18-51 Cost of ART over Time Including Extra 25% Treated for Prevention

15 BHS HTC Botswana Combination Prevention Project COHORTS ESS T0 T12 T24 T36 20% of households HIC HIV Negative CCC HIV Positive CD4>350, WHO I/II HTC- 1 A B A B HTC- 2 HTC- 3 A A A A B B B B 100% of households Study Design 30 communities Randomization 8 communities A Enhanced Care Community(Clinic Pre-ART) B Combination Prevention Community(Clinic Pre-ART + HTC

16 Mashi PMTCT Tshepo AIDS Treatment Secure the Future Foundation Botsogo Cost Effectiveness Kgatelopele Long-Term Resistance ACHAP Mma Bana PMTCT Mpepu Infant Health Mochudi Project Community-Level Prevention Clinical Trials Unit Therapy/Prevention Tshedimoso Acute Infection Tshipidi Infant Health Thibelo Discordant Couple HAART Botswana Combination Prevention Project 30 Villages CDC Losika Genetic Risk Netefatso Acyclovir UW/Gates Foundation 18-7

17 } 45% population status not known. How do we reach out new strategies for testing } Community surveys MPP reached 71% of whom 14.5% declined. (65% tested women therefore challenge with men) } Behavioural-Social issues } Buy in and Policy assimilation by MoH } Sustainability and cost

18 Ministry of Health, Botswana Acknowledgements Harvard University and Harvard School of Public Health Botswana National ARV ( MASA ) Treatment Programme African Comprehensive HIV/AIDS Partnership (ACHAP); Bill and Melinda Gates Foundation National Institutes of Health (), Bethesda, MD, USA US Gov t, BOTUSA, CDC,PEPFAR AACTG, IMPAACT, HPTN, HVTN Bristol-Myers Squibb, Secure the Future foundation, Boehringer Ingelheim Botswana-Harvard HIV Reference Laboratory, Botswana-Harvard School of Public Health Partnership, University of Washington, Seattle, USA and Florida International University (FIU), Miami, FL, USA Study Participants