Mapping and Building Consensus on Research Priorities for Women and Children

Transcription

1 Mapping and Building Consensus on Research Priorities for Women and Children Shirin Heidari, Ph.D. International AIDS Society 8 December 2009, Geneva WHO/UNAIDS Informal Consultation with Pharmaceutical Companies

2 INDUSTRY LIAISON FORUM (ILF) MISSION to accelerate scientifically promising, ethical HIV research in resource-limited countries with a particular focus on the role and responsibilities of industry as sponsors and supporters of research ILF Advisory Group: Chairs: Pedro Cahn, (Argentina), Robin Wood (South Africa) Rotating Industry-Chair: Luc Denys, Tibotec (Belgium) Quairrasha Abdool Karim, University of KwaZulu-Natal Robin Gorna, IAS Executive Director Catherine Hankins, UNAIDS, Switzerland Nicholas Hellmann, EGPAF, USA Elly Katabira, Makerere University, Uganda Souleymane Mboup, University Cheikh Anta Diop, Senegal Julio Montaner, BC Centre for Excellence in HIV/AIDS, Canada (IAS President) Rob Dintruff, Abbott Laboratories, USA Manuel Distel, Boehringer Ingelheim, Germany Sandra Lehrman, Merck, USA Michael Rabbow, Boehringer Ingelheim, Germany Jim Rooney, Gilead, USA Paul Shaper, Abbott, USA Hernan Valdez, Pfizer, USA

3 International AIDS Socirty Industry Liaison Forum (ILF) Previous and ongoing work: Consultation and discussion on Pre-Exposure Prophylaxis (PrEP) research, implementation and trial design Mapping and Building Consensus on Research Priorities for Women and Children

4 March 2009 Expert Reference Group (ERG) struck to identify and prioritize clinical and operation research questions Expert Reference Group Pedro Cahn, IAS-ILF Elly Katabira, IAS-ILF Mark Cotton, Tygerberg Children s Hospital Siobahn Crowley, WHO Isabella De Zoysa, WHO Rene Ekpini, UNICEF Catherine Hankins, UNAIDS Chewe Lou, UNICEF Ric Marlink, EGPAF Lynne Mofenson, NIH Treatment issues for Women Clinical Research Operations Reseach PMTCT and Paediatric CTS Clinical Research Operations Research

5 Process Environmental Scan Literature reviews Key informant interviews Expert Reference Group meeting Review of environmental scan Draft recommendations Multi-stakeholder consultation on recommendations (19 July 2009) Validation and Prioritization of recommendations Consensus statement (Early 2010) Based on IAS 2009 consultation Formal support from key organizations

6 2.1 million children younger than 15 years living with HIV South & South-East Asia [ ] Sub-Saharan Africa 1.8 million [ million] Oceania 1100 [1200] 1000 children under 15 years of age become infected each day UNAIDS, 2009 Report on the global AIDS epidemic

7 Number of children newly infected with HIV in % lower than in 2001 In 2008, newly infected 280,000 children died in AIDS in 2008 Source: Towards Universal Access, Progress Report 2009, World Health Organization, UNAIDS and UNICEF

8 Advances June 2009: 56 paeditric ARV pre-qualified by WHO (cmp 42 June 2008) Simplified assays on dried blood spots for diagnosing (Ou et al., 2007) Early antiretroviral therapy to reduce infant mortality by 76% (Violari et al. 2008) ART and co-trimoxazole prophylaxis reduced mortality among HIV-infected children by 6-fold (Walker et al., 2007)

9 Percentage of children receiving antiretroviral therapy in low- and middle-income countries,

10 CLINICAL: PMTCT/Paediatric Tx 1. Invest in innovative drug manufacturing and delivery system to address urgent need for appropriate paediatric formulations 2. Evaluate a range of weightadjusted dosage recommendations and fixed dose combinations (FDCs) for children. Source: MDG Gap Task Force Report 2009:

11 CLINICAL: PMTCT/Paediatric Tx 3. Invest in innovative TB and HIV diagnostics and monitoring to facilitate early infant diagnosis and treatment 4. Review currently enrolled clinical trials and conduct necessary clinical studies to evaluate impact of comorbid conditions and treatment on drug dosage and toxicity ( priority to TB, malaria and malnutrition)

12 CLINICAL: PMTCT/Paediatric Tx 5. Ensure a more comprehensive pharmacovigilance system by expanding the existing antiretroviral pregnancy registry to include low and middle-income country cohorts/pilots and establishing appropriate follow-up to evaluate the impact of ARV exposure in utero or during extended infant prophylaxis on uninfected children in resource-limited settings 6. Review existing data and currently enrolled trials to establish optimal treatment strategies for children

13 Acknowledgement Many thanks to Rodney Kort, Consultant, Clemens Rolls, Consultant, Edith Gruslin, IAS, IAS-ILF Expert Reference Group, IAS-ILF advisory group For more information see: Contact us: