Author(s): Ruane PJ, Ain D, Stryker R, Meshrekey R, Soliman M, et al.
Background & aims: We conducted an open-label phase 2 study to assess the efficacy and safety of the oral nucleotide polymerase inhibitor sofosbuvir in combination with ribavirin in patients of Egyptian ancestry, chronically infected with genotype 4 hepatitis C virus (HCV).
Methods: Treatment-naive and previously treated patients with genotype 4 HCV were randomly allocated in a 1:1 ratio to receive sofosbuvir 400mg and weight-based ribavirin, for 12 or 24 weeks. The primary efficacy endpoint was the proportion of patients with sustained virologic response (HCV RNA <25IU/ml) 12 weeks after cessation of therapy (SVR12).
Results: Thirty treatment-naive and thirty previously treated patients were enrolled and treated for 12 weeks (n=31) or 24 weeks (n=29). Overall, 23% of patients had cirrhosis and 38% had diabetes. 14% of treatment-naive patients were interferon ineligible and 63% of treatment-experienced patients had prior non-response. SVR12 was achieved by 68% of patients (95% CI, 49-83%) in the 12-week group, and by 93% of patients (95% CI, 77-99%) in the 24-week group. The most common adverse events were headache, insomnia, and fatigue. No patient discontinued treatment due to an adverse event.
Conclusions: The findings from the present study suggest that 24 weeks of sofosbuvir plus ribavirin is an efficacious and well tolerated treatment in patients with HCV genotype 4 infection.
Referred From: https://www.ncbi.nlm.nih.gov/pubmed/25450208
Author(s): Choo QL, Kuo G, Weiner AJ, Overby LR, Bradley DW, et al.
Author(s): Global Burden Of Hepatitis C Working Group
Author(s): Pawlotsky JM, Chevaliez S, McHutchison JG
Author(s): Thompson A, Patel K, Tillman H, McHutchison JG
Author(s): Messina JP, Humphreys I, Flaxman A, Brown A, Cooke GS, et al.
Author(s): Al Traif I, Al Balwi MA, Abdulkarim I, Handoo FA, Alqhamdi HS, et al.
Author(s): Ray SC, Arthur RR, Carella A, Bukh J, Thomas DL
Author(s): Benhamou Y, Moussalli J, Ratziu V, Lebray P, De Backer K, et al.
Author(s): Omland LH, Osler M, Jepsen P, Krarup H, Weis N, et al.
Author(s): Reddy KR, Wright TL, Pockros PJ, Shiffman M, Everson G, et al.
Author(s): Hasan F, Asker H, Al-Khaldi J, Siddique I, Al-Ajmi M, et al.
Author(s): Alfaleh FZ, Hadad Q, Khuroo MS, Aljumah A, Algamedi A, et al.
Author(s): Derbala M, Amer A, Bener A, Lopez AC, Omar M, et al.
Author(s): El Makhzangy H, Esmat G, Said M, Elraziky M, Shouman S, et al.
Author(s): Kamal SM, Ahmed A, Mahmoud S, Nabegh L, El Gohary I, et al.
Author(s): Abdo AA, Al-Ahdal MN, Khalid SS, Helmy A, Sanai FM, et al.
Author(s): Kamal SM, E Kamary SS, Shardell MD, Hashem M, Ahmed IN, et al.
Author(s): MartÃn-Carbonero L, Puoti M, GarcÃa-Samaniego J, De Luca A, Losada E, et al.
Author(s): Issa H
Author(s): Kowdley KV, Lawitz E, Crespo I, Hassanein T, Davis MN, et al.
Author(s): Lawitz E, Mangia A Wyles D, Rodriguez-Torres M, Hassanein T, et al.
Author(s): Wehmeyer MH, Jordan S, Lüth S, Hartl J, Stoehr A, et al.
Author(s): Steinebrunner N, Sprinzl MF, Zimmermann T, Wörns MA, Zimmerer T, et al.
Author(s): Moreno C, Hezode C, Marcellin P, Bourgeois S, Francque S, et al.
Author(s): Hézode C, Hirschfield GM, Ghesquiere W, Sievert W, Rodriguez-Torres M, et al.
Author(s): Hézode C, Alric L, Brown A, Hassanein T, Rizzetto M, et al.
Author(s): Jensen D, Sherman KE, Hézode C, Pol S, Zeuzem S, et al.
Author(s): Zoulim F, Liang TJ, Gerbes AL Aghemo A4, Deuffic-Burban S5, et al.
Author(s): Petersen T, Townsend K, Gordon LA, Sidharthan S, et al.
Author(s): Molina JM, Orkin C, Iser DM, Zamora FX, Nelson M, et al.
Author(s): Doss W, Shiha G, Hassany M, Soliman R, Fouad R, et al.
Author(s): Lawitz E, Sulkowski MS, Ghalib R, Rodriguez-Torres M, Younossi ZM, et al.
Author(s): Sulkowski MS, Gardiner DF, Rodriguez-Torres M, Reddy KR, Hassanein T, et al.
Author(s): Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, et al.
Author(s): Kohli A, Kapoor R2, Sims Z3, Nelson A4, Sidharthan S3, et al.
Author(s): Charlton M, Everson GT, Flamm SL, Kumar P, Landis C, et al.
Author(s): Hézode C, Asselah T, Reddy KR, Hassanein T, Berenguer M, et al.
Author(s): Zeuzem S, Ghalib R, Reddy KR, Pockros PJ, Ari ZB, et al.