Randomized trial of peginterferon alfa-2b and ribavirin for 48 or 72 weeks in patients with hepatitis C virus genotype 1 and slow virologic response.
| Title: | Randomized trial of peginterferon alfa-2b and ribavirin for 48 or 72 weeks in patients with hepatitis C virus genotype 1 and slow virologic response. |
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| Authors: | Buti M; Lurie Y; Zakharova NG; Blokhina NP; Horban A; Teuber G; Sarrazin C; Balciuniene L; Feinman SV; Faruqi R; Pedicone LD; Esteban R; SUCCESS Study Investigators: Berr F; Gschwantler M; Delwaide J; Nevens F; Anderson F; Bilodeau M; Feinman S; Hilzenrat N; Kaita K; Levstik M; Shafran S; Wong F; Yoshida E; Hejda V; Krechler T; Sperl J; Urbanek P; Buhl M; Pedersen C; Ring Larsen H; Farkkila M; Botta Fridlundg D; Bourliere M; Cacoub P; Guyader D; Hezode C; Larrey D; Mathurin P; Ouzan D; Tran A; Trepo C; Vinel JP; Zarski JP; Arnold J; Berg T; Buggisch P; Encke J; Gelbmann C; Gerken G; Goeser T; Gunther R; Klinker H; Mauss S; Rasenack J; Rossol S; Singer M; Wiedmann K; Zachoval R; Bassaris H; Dimitroulopoulos D; Koskinas J; Manolakopoulos S; Raptopoulou Gigi M; Dalmi L; Gervain J; Jancsik V; Bar Meir S; Melzer E; Nimer A; Shouval D; Sikuler E; Zuckerman E; Craxi A; Pinzello G; Irnius A; Sukys Z; Sumskiene J; Florholmen J; Karlsen L; Cianciara J; Gietka A; Gladysz A; Halota W; Juszczyk J; Matos L; Sarmento e. Castro R; Valente C; Rodriguez Perez F; Morozov V; Rafalsky V; Aguilar Reina J; Barcena Marugan R; Calleja J; Dalmau Obrador B; Garcia Bengoechea M; Lopez Morante A; Moreno Otero R; Nunez Martinez O; Ortiz Seuma J; Pedreira Andrade J; Pons Romero F; Rodriguez Garcia M; Sanchez Tapias J; Such Ronda J; Viver Pi Suner J; Zozaya Urmenata J; Weiland O; Westin J; Cerny A; Gonvers JJ; Heim M; Mullhaupt B; Dubynska H; Golubovska O; Gubergrits N; Herasun B; Ipatova D; Kharchenko N; Moroz L; Topolnytskyy V; Vozianova Z; Cramp M; Ryder S.; RIZZETTO, Mario |
| Contributors: | Buti M, Lurie Y, Zakharova NG, Blokhina NP, Horban A, Teuber G, Sarrazin C, Balciuniene L, Feinman SV, Faruqi R, Pedicone LD, Esteban R; SUCCESS Study Investigators: Berr F, Gschwantler M, Delwaide J, Nevens F, Anderson F, Bilodeau M, Feinman S, Hilzenrat N, Kaita K, Levstik M, Shafran S, Wong F, Yoshida E, Hejda V, Krechler T, Sperl J, Urbanek P, Buhl M, Pedersen C, Ring-Larsen H, Farkkila M, Botta-Fridlundg D, Bourliere M, Cacoub P, Guyader D, Hezode C, Larrey D, Mathurin P, Ouzan D, Tran A, Trepo C, Vinel JP, Zarski JP, Arnold J, Berg T, Buggisch P, Encke J, Gelbmann C, Gerken G, Goeser T, Gunther R, Klinker H, Mauss S, Rasenack J, Rossol S, Singer M, Teuber G, Wiedmann K, Zachoval R, Bassaris H, Dimitroulopoulos D, Koskinas J, Manolakopoulos S, Raptopoulou-Gigi M, Dalmi L, Gervain J, Jancsik V, Bar-Meir S, Melzer E, Nimer A, Shouval D, Sikuler E, Zuckerman E, Craxi A, Pinzello G, Rizzetto M, Irnius A, Sukys Z, Sumskiene J, Florholmen J, Karlsen L, Cianciara J, Gietka A, Gladysz A, Halota W, Juszczyk J, Matos L, Sarmento e Castro R, Valente C, Rodriguez-Perez F, Morozov V, Rafalsky V, Aguilar Reina J, Barcena Marugan R, Calleja J, Dalmau Obrador B, Garcia Bengoechea M, Lopez Morante A, Moreno Otero R, Nunez Martinez O, Ortiz Seuma J, Pedreira Andrade J, Pons Romero F, Rodriguez Garcia M, Sanchez-Tapias J, Such Ronda J, Viver Pi-Suner J, Zozaya Urmenata J, Weiland O, Westin J, Cerny A, Gonvers JJ, Heim M, Mullhaupt B, Dubynska H, Golubovska O, Gubergrits N, Herasun B, Ipatova D, Kharchenko N, Moroz L, Topolnytskyy V, Vozianova Z, Cramp M, Ryder S. |
| Publication Year: | 2010 |
| Collection: | Università degli studi di Torino: AperTo (Archivio Istituzionale ad Accesso Aperto) |
| Description: | The benefit of extending treatment duration with peginterferon (PEG-IFN) and ribavirin (RBV) from 48 weeks to 72 weeks for patients with chronic hepatitis C genotype 1 infection has not been well established. In this prospective, international, open-label, randomized, multicenter study, 1,428 treatment-naïve patients from 133 centers were treated with PEG-IFN alfa-2b (1.5 μg/kg/week) plus RBV (800-1,400 mg/day). Patients with detectable hepatitis C virus (HCV) RNA and a ≥2-log(10) drop in HCV RNA levels at week 12 (slow responders) were randomized 1:1 to receive 48 weeks (n = 86) or 72 weeks (n = 73) of treatment. Sustained virologic response (SVR) rates were 43% in slow responders treated for 48 weeks and 48% in slow responders treated for 72 weeks (P = 0.644). Relapse rates were similar in slow responders treated for 48 or 72 weeks (47% versus 33%, P = 0.169). The safety profile was similar in both treatment arms; serious adverse events leading to discontinuation of treatment were observed in 3.5% of slow responders treated for 48 weeks and 8.2% of those treated for 72 weeks. Among slow responders with a |
| Document Type: | other/unknown material |
| Language: | English |
| Relation: | http://hdl.handle.net/2318/134711 |
| DOI: | 10.1002/hep.23816 |
| Availability: | http://hdl.handle.net/2318/134711; https://doi.org/10.1002/hep.23816 |
| Accession Number: | edsbas.2DDFE1B |
| Database: | BASE |