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MSF operations in 2016

Overcoming remaining challenges: implementers perspectives on access to HBV and HCV diagnostics and treatments. I. Andrieux-Meyer , J. Burry , S. Balkan, A. Mesic , D. Maman, A.Loarec , D.Donchuk , K. Herboczek , M de Souza . Médecins Sans Frontières

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MSF operations in 2016

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  1. Overcoming remaining challenges: implementers perspectives on access to HBV and HCV diagnostics and treatments I. Andrieux-Meyer , J. Burry, S. Balkan, A. Mesic, D. Maman, A.Loarec, D.Donchuk, K. Herboczek, M de Souza. Médecins Sans Frontières 3rd International HIV/Viral Hepatitis Co-infection Meeting Sunday,17 July 2016; IAS, Durban, South Africa

  2. MSF operations in 2016 • HCV mono-and HIV co-infection: Cambodia, India, Pakistan, Uzbekistan (MDRTB), South Africa Cap Town.( UNITAID / MSF) • HCV –HIV co-infection: Myanmar, India, Iran, Mozambique, Kenya (UNITAID /MSF). • HCV Exploratory missions: Vietnam, India, Ukraine. • HBV ( PMTCT, HBV mono care) : Myanmar, Mozambique, CAR, Ivory Coast, DRC Kivu.

  3. DAA Target product profile for resource limited settings • Safe, efficacy >90% even 95% in people withcirrhosis or not, mono ou co-infectedwith HIV. • Pan-genotypic. • Very good tolerability in people withadvancedliver and/or renaldisease. • No interaction withantiretroviraltherapy, anti-TB drugs, includingrifampicin and MDR or XDR TB treatements. • Or possibility to adapt the dose in case of interaction ( thiscanexclude FDC) • Compatibility in pregnantwomen, formulations for children and adolescents • Compatibility with Oral Substitution Therapy , contraception. • Preserve a second line option

  4. Profil of DAAS development for RLS

  5. Profil of DAAs development for RLS (2)

  6. Overview MSF activities in HCV - all sections

  7. MSF HCV treatments guidelines • Genotypes 1,3,4,5,6: • preferred regimen: SOFOSBUVIR /DACLATASVIR, • alternatives: SOFOSBUVIR RIBAVIRIN, or SOFOSBUVIR LEDIPASVIR ( except GT3) • Need to collect data for SOFOSBUVIR /DACLATASVIR in GT 5 &6 • Genotype 2: • Preferred regimen: SOFOSBUVIR RIBAVIRIN or SOFOSBUVIR DACLATASVIR, • alternative SOFOSBUVIR LEDIPASVIR

  8. DNDi/Pharco: Sofosbuvir ravidasvir • Goal: short, pangenotypic, easy to use, high efficacy, safe, all oral. • Phase II/III Malaysia Thailand started, n=750. • Possible partnership with South Africa, Vietnam. • Price <300 $ per course of 12 weeks • License territories: include Asia, Latin America, Eastern Europe. • Possibility to negotiate a license that covers Europe from 2018.

  9. Ravidasvir Licenses territories Courtesy DNDi.

  10. Global price for DAAs June 2015 (and March 2016 for India, South Africa, Brazil, ). #for these DAAS *generic/ special price ** full TT +/- estimated Note: price per month in USD for Public Health.

  11. Sofosbuvir • Hetero - signed VL with Gilead, limited to the territory of the license. 200 $ per bottle.lead-time 4-6 weks to get to Europe. • Pharco -no VL signed . Lead-time 1-2 weeks to get to Europe. WHO PQ. • Registered in Ukraine, Azerbaijan , Kyrgyzstan • Filed for registration in Pakistan, Kenya, Myanmar, Cambodia , Vietnam , Ethiopia , Moldova, Turkmenistan,  Sudan , Belarus, Russia , Lebanon , Georgia, Kazakhstan

  12. Sofosbuvir `ledipasvir • Not good in genotype 3 patients • Alternative to sof daclatasvir otherwise. • Price around $400 per bottle. • No more registered • Lead time 2 months • No generic identified yet, no generic pre-qualified.

  13. How do governments in resource limited settings, and patients, get access to DAAs? • Champion countries: India, Georgia, Egypt, Pakistan: national programs • Mongolia, Ukraine: very good community organisations. • Elsewhere: • In hospitals: special import permit • Patient: • Buyers’ clubs : James Freeman: www.fixhepc.com • Name patient import • Access to Indian pharmacies with a medical prescription / Indian activist networks. • In Egypt: tour & treat with Pharco

  14. Access to treatment for HBV is discriminatory

  15. Access to tenofovir or entecavir • The lowest price for tenofovir is 38 usd ppy ( WHO Global Pricing Reporting Mechanism 2014) • Entecavir price could be as low as 36 USD PPY. • Mono-infected HBV patients do not yet have access to this price structure because countries may not want or not know they can procure affordable generics of TDF to non HIV patients, using the Medicines Patent Pool agreement for TDF for 112 countries. • But there is no global financing mechanism in place for HBV, and the drugs need to be registered in the countries for HBV mono-infection indication.

  16. Overcoming barriers to HCV & HBV diagnostics and treatments • Access to reliable epidemiological data , investigation of the patterns of transmission. • Access to reliable and affordable diagnostics (WHO pre-qualified, rapid diagnostic tests, multi-analytic PCR platforms, Point of Care HCV viral load, core antigen testing). • Access to care without discrimination, including women and children, people who use drugs , key populations. • Demonstration projects: performance & feasibility at large scale, simplification, task shifting, training, including screening-prevention-treatment in different epidemiological contexts. • Promote free generic competition: either through voluntary or compulsory licensing; patent oppositions / invalidations, and use of all TRIPS flexibilities. Goal: diagnostic – HCV cure package< $300 per cure. • Treatment access is slow, complicated, and still extremely limited in June 2016 in resource limited settings, with concerns about anti-diversion rules, and long delays/drug registration and drug orders. • Access to HBV diagnostics-treatments- and birth dose immunization remain dramatically restricted. HIV PMTCT= perfect opportunity for viral hepatitis care integration.

  17. Remerciements • Key informants: GitenKhwairakpam, OthomanMellouk, World Hepatitis Alliance Bridie Taylor, Charles Gore,LauraCiaffi, Serge Eholié, AbshiroHalake, FumiLesi, PonsianoOcama, Mark Sonderup, • MSF teams : M. Balasegaram, R. Malpani, C. Perrin, Y. Hu, J. Keenan, S. Shettle, T.Roth, G.Elder, L. Menghaney, S. Gupka, J.Burry, A. Loarec, M. de Souza, D. Maman, D. Donchuk, K. Herboczek ,A. Mesic, C.Ferreyra,S. Balkan, M. Berthelot, J. Goiri, C. Jamet, M. Serafini, K.Lavelle, S.Cristofani, L.Molfino, M.Fernandez, P.Boulle, M.Serafini, MSF Ukraine, MSF India, MSF Myanmar, MSF Iran, MSF Pakistan, MSF Kenya, MSF Mozambique, MSF Chad/Mali, MSF Uganda. • Liverpool University: A.Hill. Bristol University & LSHTM: P.Vickerman, N.Martin. • UNITAID team: Ph.Duneton, K.Timmermans,Ph.DousteBlazy, S.de Lussigny. • HôpitauxUniversitaires de Genève : A.Calmy, T.Lecomte, V. Pecoul, F.Olearo, O.Tshikung, M.Rougemont. B. Browers, A. François, S. Yerly, F. Negro, L.Kaiser, • WHO team: G.Hirschall, S. Wiktor, P.Easterbrook, S.Hess, H.Harmanci, A.Ball, H.Souissi, N.Ford, A.Vester, et le WHO HCV Guidelines Development Group: EA Affonso Araujo, Manal El-Sayed, Ch.Gore, G.Khwairakpam, K.Lacombe, O.Lesi, DR Nelson, P.Ocama, B.Oidov,J.Rockstroh, T.Swan, LE.Taylor, E.Thompson, L.Wei, • DNDi team: B.Pecoul, M. Lallemant, G.Diap, JP Paccaud, G.Bilbe, JF Alesandrini, F.Saugnac, JR Kiechel, J.Lee, F.Simon, J.Brenner, P.Boulet. • FixHep C and J.Freeman • Questions: isabelle.andrieux-meyer@geneva.msf.org

  18. SIGN THE DOTTED LINE • 1. DIAGNOSTICS • No out-of-pocket expenditures for TB tests • Rapid molecular test (i.e. Xpert) is initial diagnostic for all • Second-line drug susceptibility testing is available • 2. MODELS OF CARE • Treatment initiation: TB at primary level, DRTB at district/below • Compulsory hospitalisation is not required • Immediate ART is offered to people living with HIV • 3. DRUG REGULATION • NTP procures quality-assured TB drugs • Prescriptions are required for all TB drugs (not over-the-counter) • TB drugs benefit from accelerated registration • 4. DS-TB TREATMENT • Daily fixed-dose combinations is standard of care • Treatment, including for children, reflect WHO guidance • TB contacts are screened, children & PLWHA receive IPT • 5. DR-TB TREATMENT • DR-TB treatment reflects WHO guidance • WHO recommended DR-TB drugs are on national EML • New drugs are available via import waivers until full registration STEPUPFORTB.ORG

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