Author(s): Benhamou Y, Moussalli J, Ratziu V, Lebray P, De Backer K, et al.
Background: This partially blinded, randomized, phase 2a C210 study evaluated the antiviral activity of telaprevir-based regimens in treatment-naive patients with chronic hepatitis C virus (HCV) genotype 4 infection.
Methods: Twenty-four patients received telaprevir 750 mg every 8 hours for 15 days (T; n = 8), telaprevir in combination with pegylated interferon alfa-2a and ribavirin (Peg-IFN/RBV) for 15 days (TPR; n = 8), or Peg-IFN/RBV plus placebo for 15 days (PR; n = 8), followed by Peg-IFN/RBV for 46 or 48 weeks. The primary objective was to assess the effect of telaprevir on HCV RNA levels.
Results: HCV RNA levels decreased slightly with T and PR; TPR produced substantial, rapid declines. On day 15, median reductions in the HCV RNA load from baseline were -0.77, -4.32, and -1.58 log10 IU/mL for T, TPR, and PR, respectively, and 0 patients in the T group, 1 in the TPR group, and 0 in the PR group had undetectable HCV RNA. Five of 8 patients who received telaprevir monotherapy had viral breakthrough within 15 days of treatment. Adverse event incidence was similar across treatments and comparable with the incidences from previous clinical trials. One patient (in T group) had a serious adverse event (considered unrelated to telaprevir) that led to treatment discontinuation.
Conclusions: Telaprevir with Peg-IFN/RBV had greater activity than Peg-IFN/RBV treatment or telaprevir monotherapy against HCV genotype 4. Telaprevir was generally safe and well tolerated. Further investigation of telaprevir combination therapy in patients with HCV genotype 4 infection is warranted.
Referred From: https://www.ncbi.nlm.nih.gov/pubmed/23801602
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): 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): Ruane PJ, Ain D, Stryker R, Meshrekey R, Soliman 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.