CROI 2017 Abstract e-Book

Abstract eBook

Poster and Themed Discussion Abstracts

569 NINETY-SIX % SVR RATES USING IMPORTED GENERIC DAAs FOR PATIENTS WITH HEPATITIS C Andrew Hill 1 , Giten Khwairakpam 2 , James Wang 3 , Sergey Golovin 4 , Julia Dragunova 5 , Rachel Smith 6 , Vicky Houghton-Price 6 , Roxanna S Korologou-Linden 7 , Anton Pozniak 8 , Greg Jefferys 9 1 St Stephens Cntr, Chelsea and Westminster Hosp, London, UK, 2 TREAT Asia/amfAR, Bangkok, Thailand, 3 Ci Run Hlth Information Consulting Co. Ltd., Kunming, China, 4 Intl Treatment Preparedness Coalition, St. Petersburg, Russian Federation, 5 Intl Treatment Preparedness Coalition and GEPATITKA Community, St. Petersburg, Russian Federation, 6 Metavirology Ltd, London, UK, 7 Imperial Coll London, London, UK, 8 Chelsea and Westminster NHS Fndn Trust, London, UK, 9 Univ of Tasmania, Tasmania, Australia Background: High prices for Direct Acting Antivirals (DAAs) are a barrier to treatment access. High-income countries such as Russia, China, Southeast Asia and Eastern Europe are not included in voluntary license agreements, and prices of DAAs in these countries are very high. In most of these countries, individual citizens can legally import non-registered medicines for their personal use. An increasing number of individuals are treating their Hepatitis C infection with generic drugs produced in India, China or Egypt. This analysis assessed the effectiveness of generic DAAs imported into 40 countries. Methods: 568 patients sourced generic versions of sofosbuvir (SOF), ledipasvir (LDV) and daclatasvir (DCV) from suppliers in India, Bangladesh, China and Egypt via established Buyers Clubs and personal connections. The choice of DAAs and the length of treatment were determined based on baseline RNA levels, HCV Genotype and stage of fibrosis. Patient HCV RNA levels were evaluated pre-treatment, during treatment, at end of treatment (EOT) and for SVR 4, 12, and 24 weeks. Results: Overall, 568 patients submitted results (146 from an Australian Buyers Club, 154 from a Chinese Buyers Club, 200 from a Russian Buyers Club, 68 from a Southeast Asian Buyers Club). Of these, 121 received SOF (59 with RBV), 169 received SOF/LDV (18 with RBV), 279 received SOF/DCV (15 with RBV) and 1 received SOF/LDV/DCV. Overall, the patients were 64%male with a mean age of 43.2 years; 47%were Genotype 1, and 11% cirrhotic. Mean baseline HCV RNA was 6.9 log10 IU/mL. A rapid virological response (RVR) was observed in 94% (29/31) of patients treated with SOF/RBV, 84% (137/163) of the patients treated with SOF/DCV and 80% (75/94) of the patients treated with SOF/LDV. Based on currently available data, the percentage of patients with HCV RNA<=”” div=””> Conclusion: Treatment with legally imported generic DAAs achieved high rates of HCV RNA undetectability at the end of treatment and SVR in the majority of patients evaluated to date. The efficacy observed was similar to Phase 3 trials of the branded medicines. Mass treatment with the current generic DAAs is an alternative and feasible route of accessing economical DAAs, where the high-prices for branded DAAs prevent access to treatment.

Poster and Themed Discussion Abstracts

570 VIRAL KINETICS PREDICT RESPONSE TO ALL-ORAL THERAPY AGAINST HCV GENOTYPE 3 INFECTION Juan A. Pineda 1 , Luis E. Morano-Amado 2 , Rafael Granados 3 , Juan Macías 4 , Francisco Téllez 5 , Miguel García-Deltoro 6 , Maria J. Rios-Villegas 7 , Antonio Collado 8 , Karin Neukam 4 , for the GEHEP-MONO/ HEPAVIR-DAA, RIS-HEP07 and RIS-HEP13 Study Groups 1 Hosp Univ de Valme, Seville, Spain, 2 Hosp Univ Alvaro Cunqueiro, Vigo, Spain, 3 Hosp Univ de Gran Canaria Dr Negrín, Las Palmas de Gran Canaria, Spain, 4 Hosp Univ de Valme, Sevilla, Spain, 5 Hosp de La Línea, La Línea de la Concepción, Spain, 6 Hosp General de Valencia, Valencia, Spain, 7 Hosp Univ Virgen Macarena, Sevilla, Spain, 8 Hosp Univ Torrecárdenas, Almeria, Spain Background: Rates of sustained virologic response (SVR) to currently recommended therapy against hepatitis C virus (HCV) infection based on all-oral direct-acting antivirals (DAA) are generally high. However, in specific subsets, as it is the case for HCV genotype 3-infected, cirrhotic individuals, SVR rates can be suboptimal. The aim of this study was to determine the predictive capacity of response at week 4 for the achievement of sustained virologic response 12 weeks after the scheduled end of therapy date (SVR12) to treatment against HCV infection with all-oral DAA-based regimens.

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