TasP for PWID in low-ressource settings: challenges and opportunities Annual CREIDU-Colloquium: HIV and hepatitis C treatment as prevention The promise, the pitfalls and the public health benefits Dr Niklas Luhmann Harm Reduction and HIV/AIDS Advisor Médecins du Monde, France NOUS SOIGNONS CEUX QUE LE MONDE OUBLIE PEU A PEU Outline of the presentation » » » Harm Reduction in Médecins du Monde TasP for HIV in low ressource settings TasP for HIV and HCV in PWID » » Myanmar case study Discussion and conclusion Harm Reduction in Médecins du Monde Background: Harm Reduction in Médecins du Monde » Guiding principles for MdM HR programs: – Service delivery – Capacity building and dissemination – Advocacy: • Access to HR in Africa • Acess to viral hepatitis C prevention and treatment services • Drug policy reform (national/global) » Our programs are strongly based in a community and human rights based approach. Background: Harm Reduction in Médecins du Monde ART for HIV/AIDS in MdM : » » » » Only two remaining programs in which MdM provides ART directly MdM has no current, specific TasP research ART elligibility: generally with threshold of CD4 count 350 cells/mm3 General context: – No full adaption of latest, revidsed 2013 WHO guidelines – Lack of funding and implementation capacities to fully implement 2013 WHO guidelines in many countries Background: Harm Reduction in Médecins du Monde Treatment programs for HCV within MdM: » No treatment program started yet » Planning of a treatment program in Tbilissi Georgia: focus on PWID » Very high treatment costs (diagnostics and drugs): only advocacy can bring real change TasP: Defintion » WHO working definition of TasP for HIV and TB (WHO 2012; Programmatic Update Antiretroviral Treatment as Prevention (TasP) of HIV and TB) ART irrespective of CD4+ cell count for the prevention of HIV and TB. This includes provision of ART to people living with HIV who are: – severely immunocompromised with AIDS and/or have a CD4+ count ≤350 cells/mm3 – those with higher CD4+ cell counts >350 cells/mm3 – does not include the use of antiretrovirals (ARVs) for post-exposure prophylaxis (PEP), pre-exposure prophylaxis (PrEP) and ARVbased microbicides » N.B.: There is no WHO working definition for TasP for HCV Background: HIV-TasP in low and middle income countries » ART coverage worldwide: 9.7 million people in 2012, with 7.5 million people in WHO African Region: (WHO, HIV TREATMENT GLOBAL UPDATE ON HIV TREATMENT, 2013) » » » » Estimated 15 Million people in need globally with cut-off of CD4 count 350 ( Coverage rate: 65%) Under latest WHO guidance: if elligibily includes serodiscordant couple, all pregnant women, children younger than 5 years of age as well as all patients with CD4 lower than 500 cells/mm3: estimated 25 Million elligible (USAID, Technical brief, 2012) Funding crisis: difficulties to increase current coverage rates Some countries worldwide, such as Zambia, now implement TASP for serodiscordant couples or in the framework of PMTCT (Option B+). (WHO 2012; Programmatic update) » No country specifically recommending earlier initiation in key populations TasP and the (leaky) cascade of care Main bottlenecks for reaching high numbers of PWID with effective treatment » 1. Testing: Stigma, criminalization and human rights abuses act as strong deterrents to accessing testing services » 2. Linkage to care: PWID have often had very bad experiences with health care system. Support for referral needed. » 3. Enrolling in care and assessing for treatment. Many healthcare workers have no experience with PWID care. » 4. Maintaining on treatment: Adherence support Background: HIV-TasP in PWID » » » » Evidence from Bristish Columbia shows that treatment has a prevention utility among PWID (Wood E, BMJ 2009) Combination of NSEP+OST+ART is most effective for HIV prevention among PWID From experience we know that people who inject drugs are far less likely to be considered for ARV programs or enrolment conditional on ‘abstinence’ In 2010, the Reference Group to the United Nations on HIV and Injecting Drug Use reported that, worldwide, only 4% of HIV-positive people who inject drugs were receiving ART (Mathers BM, Lancet 2010) Background: HCV-TasP in PWID » Different epidemiological models from high-income countries as well as one model from Vietnam, show considerable prevalence reductions over time among PWID through treatment with pegINF/RBV (Martin NK et al. Journal of Hepatology 2011; Hellard ME etal.. Med J Aust 2012; Durier N et al. Plos One 2012) » The preventive impact may be increased through access to DAA-based treatment regimens or in contexts with predominant genotypes 2 and 3 among PWID (Martin NK.et al. Hepataology 2013) » » Combination with high coverage OST and NSEP very important for preventive effectiveness (Martin NK et al. Clin Infect Dis 2013) Very little access to HCV treatment in low ressource settings around the world. Background: TasP in PWID cont. » Era of biomedical interventions: negative impact on community based prevention possible (Luhmann, MdM, 2013) » TasP needs the meaningful involvement of PWID » Individual vs. public health: • Benefits have to outweigh the related risks • Must be voluntary. Public health is not a treatment indication • Other prevention options may be preferred TasP must be part of a comprehensive prevention package. Never stand-alone! Case study Myanmar General presentation of the context: – MdM in Myanmar: • Harm Reduction program targeting PWID in Kachin State since 1996 • Comprehensive HR approach (including NSEP, OST and ARV) in 3 main sites – Drug use epidemic: • Heroin use epidemic is mostly concentrated in regions situated close to poppy production (Shan and Kachin States) • Parallel to that, there is also an urban drug use epidemic in large cities such as Mandalay and Yangon. – HIV prevalence among PWID: • HIV prevalence among PWID at national level 18.7% in 2013 (HIV Sentinel Sero‐surveillance Survey Report, 2013). Slight increase from 18% in 2012. Case study Myanmar Coverage of NSEP + OST: »Estimated 75,000 (range: 60,000-90,000) people inject drugs in the country (0.23% population prevalence of injecting drug use among 15-64 year-olds) – NSEP coverage 30% (UNAIDS. 2013) – Total number of Needles and Syringes distributed in 2013 : 11 Million; 147 syringes/user/year (2013 National Progress report, NAP) – Total number of people on OST at the end of 2013: 5.9% coverage (4397 patients enrolled) (2013 National Progress report, NAP) » Coverage of ARVs: – Number of people receiving ARV at the end of 2013 (NAP): 67,643 – Coverage: 54,1% of all people in need of treatment – No precise data regarding the number of PWID receiving treatment Case study Myanmar Policy context: » Official eligibility criteria in national guidelines: CD4-count: 350 cells/mm3 and below. » No mention of particular eligibility for PWID » Rapid ARV scale up / decentralization process is in itself a huge challenge for the MoH at the moment. » Reviewed version of Myanmar national treatment guidelines currently under discussion: Eligibility may possibly be extended to those with a CD4 count below 500 for sero-discordant couples and Key Affected Populations (FSW, MSM, PWUD) » UNAIDS HIV investment case: Needle and syringe programming gives highest return on investment in terms of overall infections averted (UNAIDS. Myanmar Invest Now to End AIDS; 2013) Case study Myanmar Eligibility criteria in MdM program in 2013: – Medical eligibility criteria: » 1. WHO stage 3 or 4 » 2. CD4 < 350 cells/ul » 3. Patients with active TB disease regardless of CD4 count – Social eligibility criteria: » Treatment caretaker obligatory » Geographical criteria »Strong efforts for adherence support in the program: home based visits, peer support etc. Case study Myanmar MdM program data » Number of different beneficiaries 2013: 6601 PWIDs reached. » 2318 were contacted in DIC » Average CD4 (on first CD4 test done) : Mean=362 (SD 231); Median = 336 (IQR 176-500) HIV cascade in Myanmar program 2000 1800 1722 1600 1400 Nr of DIC benef Nr of PWID tested 1200 Nr of PWID HIV+ 1000 Nr of PWID enrolled in care 904 Nr of PWID eligible for ART (CD4 350) 800 Nr of PWID started on ART Nr of patients retained after 12 months 600 400 200 350 274 113 47 0 42 Discussion of Myanmar case study MdM Kachin programm results: »‘Only’ 53% of DIC beneficairies are tested »Rather good linkage to care »Main bottleneck: Enrollement of elligible patients into ART »Good retention Discussion of Myanmar case study MdM Kachin programm results: Change of protocol in 2014: – Social elligibility criteria revised: • 1. Treatment care taker not obligatory anymore • 2. No more geographical criteria • 3. No more selection comitee – but ART meeting – Medical elligibility criteria: » » » » » 1. WHO stage 3 or 4 2. CD4 < 500 cells/ul 3. patients with active TB disease regardless of CD4 count 4. HBV co infected patients with the presence of chronic liver diease 5. Patients with HIV negative regular partner » Prevention utility was one main argument for the changes » Shift in paradigm Conclusion: Making HIV-TasP a reality in LMICs Ressources are limited! TasP needs more funding in low and middle income countries (LMICs) Conclusion: Making HIV-TasP a reality in LMICs Ressources are limited! TasP needs political will and increased implementation capacity Conclusion: Making HIV-TasP a reality in LMICs Access to live-saving treatment is very limited for PWID, as complex structural barriers exist in the health care system and even in HR programs! TasP needs better drug policies, less stigma and involvement of people who use drugs! Conclusion: Making HIV-TasP a reality in LMICs Combined and comprehensive strategies are the most effective! TasP should not be stand alone! Conclusion: Making HIV-TasP a reality in LMICs The treatment cascade often can be improved! TasP does not only mean to increase eligibility, but as well offering high quality services A word on HCV TasP in LMIC No TREATMENT ACCESS = No TASP A word on HCV TasP in LMIC » Preliminary conditions for TasP – Cost for diagnosis and treatment low! – All oral treatment regimes with little side effects – Investement in HCV tretment in genera