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Scaling up screening , diagnostic and treatments for HCV using the HIV programs

Scaling up screening , diagnostic and treatments for HCV using the HIV programs. Isabelle Andrieux-Meyer, MD Médecins Sans Frontières Access Campaign International Aids Conference Melbourne, July 22nd 2014 Isabelle.andrieux-meyer@geneva.msf.org. Declaration of interest.

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Scaling up screening , diagnostic and treatments for HCV using the HIV programs

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  1. Scaling up screening , diagnostic and treatments for HCV using the HIV programs Isabelle Andrieux-Meyer, MD Médecins Sans Frontières Access Campaign International Aids Conference Melbourne, July 22nd 2014 Isabelle.andrieux-meyer@geneva.msf.org

  2. Declaration of interest • No conflict of interest

  3. Scaling up screening and diagnostics for HCV using the HIV programs - Access to reliable epidemiological data • Access to HCV screening & diagnostic • Who is the most at risk? - Access to HCV treatments in 2014 in LMIC?

  4. Global Prevalence of Hepatitis C

  5. New HCV /HIV epidemiological data. Center for Disease Analysis 2013

  6. Access to HCV screening: a game changer • Globally, 59% of the world’s population has no access to hepatitis C diagnosis.Dx using serology is available in 53% of lower middle income countries, and 11% of low income countries( WHA report 2010). • HCV Scan (EY laboratories) sensibility: 100%, specificity: 93.7% ( WHO 2001) or HCV Spot (MP Medicals): average price 1-4 eur per test • MSF recommends OraQuick (Orasure, USA): Best and most up to date performance but 10-12x more expensive than other RDTs.( 14 euros/test) (sensibility: 99.2%, specificity: 99.8% ( Lee 2010) Can be done on whole blood (e.g finger prick) or oral fluid. ( MSF HCV landscape analysis 2014) • Limited evidence on the accuracy of HCV RDTs in HIV/HCV coinfection.( Shivkumar Ann Intern Med 2012)( Smith J Itl Dis 2011)

  7. Primary prevention /HCV transmission • Blood to blood contact. • Transmission in developed countries: • 90% chronic HCV infection were infected through transfusion of unscreened blood ( Alter JAMA 1990) • Or sharing contaminated needles or other drug injection equipment ( Villano SA, Drug and Alcohol Dependance 2009).HCV seroprevalence among drug users ( IDU) : 60% (Nelson PK, Lancet 2011) • Less commonly HCV is transmitted by sexual contact with an infected person, including MSM, or birth to an infected mother.( Wandeler G CID 2013) • In developing countries: • the primary sources of HCV infection are unsterilized injection equipment and infusion of inadequately screened blood and blood product .

  8. MSF UNITAID HIV-HCV grantHCV public health problem, prevalence HCV –HIV co-infection • 52.3% HCV-HIV co-infected patients in NE India (Devi KS,I nis,2005) • 67.2% in IDU in Iran ( SeyedAlinaghi S, Acta Med Iran 2011) • 10.3% in Nairobi, Kenya (Muriuki BM, BMC Research notes 2013) • 15.7% in Mozambique( Rodrigues, 2008) • 29% in North Myanmar ( MSF OCA 2014, unpublished data) • 53.3% among IDU in Ukraine ( MSF OCB, unpublished data)

  9. Whois the most at risk?preliminaryinvestigation • India: transgender people, people using drugs (IDU) • Myanmar: Migrants, IDU • Ukraine: prisoners, complex HIV patients , MDRTB, TB patients, men who have sex with men ( MSM) • Iran: Commercial sexworkers (CSW) and partners, IDU • Mozambique &Kenya: IDU, CSW?, blood recipient, invasive medical dental surgical procedure, tattoos, health care workers, prisoners, mobile populations ( migrant workers, miners) • Need to investigate patterns of transmission at country level , collect epidemiological datas

  10. HCV confirmation test: Detection of HCV RNA • HCV PCR is the most common method to detect viral RNA. It is also used to quantify the virus for treatment monitoring purpose. Usually: Abbott, Roche, Siemens quantitative VL. • HCV PCR is hardly accessible and costs >=100 USD per test. • We need affordable : • POC HCV Viral load : pipeline Wave 80, Alere, Cepheid, IQuum, Daktari. • Flexible PCR platforms ( Multitest: HBV-HIV-HCV) like Sacace generic open platform test, or Qiagen. ( MSF HCV landscape analysis 2014) Prohibitive Costs: Georgia: serology+ PCR RNA HCV+ genotype=USD135 Nigeria, India: package=500 USD

  11. 3. Genotyping & Fibrosis evaluation • The required length of peg-IFN-ribavirin treatment, or oral treatments, and the expected outcome from treatment, is dependent on the HCV genotype. • Tests, using a range of different technologies: • Abbott , Roche, Siemens tests • Sacace: generic open platform test (real time PCR) • Pipeline point-of-care test: Wave80 • New oral drugs will allow for simplification , if we have access to pan-genotypic treatment then genotyping may not be needed • Liver fibrosis can be assessed at field level using Transient elastography: Fibroscan, or serum biomarkers like APRI( Lin ZH. Hepatol 2011) ( WHO HCV Guidelines 2014).

  12. Treatment should be simple, highly effective, pan-genotypic, potent, at affordable cost, easy to take ( MSF HCV landscape analysis 2014)

  13. 3. Update EASL 2014

  14. The best components should be studied in combination and selected for market impact (MSF HCV landscape analysis 2014)

  15. Sovaldi : 84 000 USD for 12 weeks USA, 56 000 euros for 12 weeks in France France, 1700 dollars in Egypt.

  16. Gilead Access program : 60 countries belong to the lowest tiered pricing category, price negotiations for sofosbuvir ‘s price start at 300 - 350 USD per bottle of 28 tablets 900 – 1000 USD for 12 weeks . ( Gilead PR, February 2014) (there is also a compassionate use program) If you need to buy peginterferon: Merck: negotiate the Egyptian price: 40 USD per vial, including ribavirin! If you need to buy ribavirin to combine to sofosbuvir: Zydus: minimal quantity 750,000 caps, price per caps: 0.30 USD.

  17. Best price! • ribavirinezydus price: 0.30 usd per caps.1 caps= 200mg, daily dose average 1000 mg if <75 kg  = 5 capsso 12 weeks tt will cost : 126 usd24 weeks tt will cost 252 usdbest price : • 12 weeks sofosbuvir + ribavirine= 1000 + 126 = 1126 usd12 weeks sofosbuvir+ ribavirine + pegifn= 1000+126+500 = 1626 usd24 weeks sofosbuvir + ribavirine= 2000 + 252 = 2252 usd

  18. Cost per person, for 12 week course of HCV DAA * current mid-point cost of API from 3 Chinese suppliers **shows cost for 1200mg daily dose; $41 for 1000mg daily dose of ribavirin Courtesy Andrew Hill. Poster LBPE12. IAC 2014.

  19. Bundle Of Care costs- A. Hill-

  20. Interventions to overcome access barriers to HCV treatment • 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). • Access to care without discrimination, including people who use drugs. • Demonstration projects: performance & feasibility at large scale, simplification, task shifting, training, including screening-prevention-harm reduction-treatment in different epidemiological contexts. • Free generic competition • Goal: diagnostic –treatment package< 500 USD per cure.

  21. Remerciements • IAC team:J. Rockstroh, S. Moroz, A. Madden, T. Swan, S. Baghani, L. Golob, G. Dore. • WHO team: S.Wiktor, P. Easternbrook, N.Obara, N. Ford, G.Hirnschall, A. Harmanci, C.Penn, A. Ball. • HCV Guidelines Development Group: B.Smith; Y.Falck-Ytter, R.Birgin; S.Bowden; V.Chulanov; W.Doss; N.Durier; S.Eholie; J.González; C.Gore; M.El-Sayed; K.Ishii; S. M. Wasim; M.Lemoine; A.Lok; E.Kassa Lulu; M.Mizokami; D.Ocheret; F.Okoth; J.Parry; N.Méndez-Sánchez; S.KumarSarin; U.Sharma; B.Stalenkrantz;T.Swan; L.Taylor; X.Wang , J. Doyle; D.Goldberg; M.Hellard; S.Hutchinson; L.Longworth; N.Martin; R.Morgan; E.Thomson; E.Tsochatzis; Y.Yazdapanah. • MSF team : M. Balasegaram, R. Malpani, J. Cohn, T. Roberts, Y. Hu, J. Keenan, J. Arkinshall, C.Perrin, P. Cawthorn, L. Menghaney, S. Gupka, A. Bozadjian, C. Perrin,A. Loarec, M. de Souza, D. Maman, D. Donchuk, K. Herboczek , S. Balkan, M. Berthelot, J. Goiri, C. Jamet, M. Serafini, P du Cros, MSF Egypt, MSF Ukraine, MSF India, MSF Myanmar, MSF Iran, MSF Pakistan, MSF China, MSF Kenya, MSF Mozambique, MSF Chad/Mali. • Liverpool University: A.Hill. Bristol University & LSHTM: P.Vickerman, N.Martin. UNITAIDteam: Ph.Duneton, B.Waning,K.Timmermans.Ph.DousteBlazy. • Geneva University Hospital team: M.Rougemont, T.Lecomte, D.Scullier, S.De Lucia, D.Schrumpf, B. Browers, F. Negro, A. Calmy, L.Kaiser

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