Faldaprevir and deleobuvir for HCV genotype 1 infection
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Faldaprevir and deleobuvir for HCV genotype 1 infection. / Zeuzem, Stefan; Soriano, Vincent; Asselah, Tarik; Bronowicki, Jean-Pierre; Lohse, Ansgar W; Müllhaupt, Beat; Schuchmann, Marcus; Bourlière, Marc; Buti, Maria; Roberts, Stuart K; Gane, Ed J; Stern, Jerry O; Vinisko, Richard; Kukolj, George; Gallivan, John-Paul; Böcher, Wulf-Otto; Mensa, Federico J.
in: NEW ENGL J MED, Jahrgang 369, Nr. 7, 15.08.2013, S. 630-9.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Faldaprevir and deleobuvir for HCV genotype 1 infection
AU - Zeuzem, Stefan
AU - Soriano, Vincent
AU - Asselah, Tarik
AU - Bronowicki, Jean-Pierre
AU - Lohse, Ansgar W
AU - Müllhaupt, Beat
AU - Schuchmann, Marcus
AU - Bourlière, Marc
AU - Buti, Maria
AU - Roberts, Stuart K
AU - Gane, Ed J
AU - Stern, Jerry O
AU - Vinisko, Richard
AU - Kukolj, George
AU - Gallivan, John-Paul
AU - Böcher, Wulf-Otto
AU - Mensa, Federico J
PY - 2013/8/15
Y1 - 2013/8/15
N2 - BACKGROUND: Interferon-free regimens would be a major advance in the treatment of patients with chronic hepatitis C virus (HCV) infection.METHODS: In this phase 2b, randomized, open-label trial of faldaprevir (a protease inhibitor) and deleobuvir (a nonnucleoside polymerase inhibitor), we randomly assigned 362 previously untreated patients with HCV genotype 1 infection to one of five groups: faldaprevir at a dose of 120 mg once daily and deleobuvir at a dose of 600 mg three times daily, plus ribavirin, for 16, 28, or 40 weeks (TID16W, TID28W, or TID40W, respectively); faldaprevir at a dose of 120 mg once daily and deleobuvir at a dose of 600 mg twice daily, plus ribavirin, for 28 weeks (BID28W); or faldaprevir at a dose of 120 mg once daily and deleobuvir at a dose of 600 mg three times daily, without ribavirin, for 28 weeks (TID28W-NR). The primary end point was a sustained virologic response 12 weeks after the completion of therapy.RESULTS: The primary end point was met in 59% of patients in the TID16W group, 59% of patients in the TID28W group, 52% of patients in the TID40W group, 69% of patients in the BID28W group, and 39% of patients in the TID28W-NR group. The sustained virologic response 12 weeks after the completion of therapy did not differ significantly according to treatment duration or dosage among ribavirin-containing regimens. This response was significantly higher with TID28W than with TID28W-NR (P=0.03). Rates of a sustained virologic response 12 weeks after the completion of therapy were 56 to 85% among patients with genotype 1b infection versus 11 to 47% among patients with genotype 1a infection and 58 to 84% among patients with IL28B CC versus 33 to 64% with non-CC genotypes. Rash, photosensitivity, nausea, vomiting, and diarrhea were the most common adverse events.CONCLUSIONS: The rate of a sustained virologic response 12 weeks after the completion of therapy was 52 to 69% among patients who received interferon-free treatment with faldaprevir in combination with deleobuvir plus ribavirin. (Funded by Boehringer Ingelheim; SOUND-C2 ClinicalTrials.gov number, NCT01132313.).
AB - BACKGROUND: Interferon-free regimens would be a major advance in the treatment of patients with chronic hepatitis C virus (HCV) infection.METHODS: In this phase 2b, randomized, open-label trial of faldaprevir (a protease inhibitor) and deleobuvir (a nonnucleoside polymerase inhibitor), we randomly assigned 362 previously untreated patients with HCV genotype 1 infection to one of five groups: faldaprevir at a dose of 120 mg once daily and deleobuvir at a dose of 600 mg three times daily, plus ribavirin, for 16, 28, or 40 weeks (TID16W, TID28W, or TID40W, respectively); faldaprevir at a dose of 120 mg once daily and deleobuvir at a dose of 600 mg twice daily, plus ribavirin, for 28 weeks (BID28W); or faldaprevir at a dose of 120 mg once daily and deleobuvir at a dose of 600 mg three times daily, without ribavirin, for 28 weeks (TID28W-NR). The primary end point was a sustained virologic response 12 weeks after the completion of therapy.RESULTS: The primary end point was met in 59% of patients in the TID16W group, 59% of patients in the TID28W group, 52% of patients in the TID40W group, 69% of patients in the BID28W group, and 39% of patients in the TID28W-NR group. The sustained virologic response 12 weeks after the completion of therapy did not differ significantly according to treatment duration or dosage among ribavirin-containing regimens. This response was significantly higher with TID28W than with TID28W-NR (P=0.03). Rates of a sustained virologic response 12 weeks after the completion of therapy were 56 to 85% among patients with genotype 1b infection versus 11 to 47% among patients with genotype 1a infection and 58 to 84% among patients with IL28B CC versus 33 to 64% with non-CC genotypes. Rash, photosensitivity, nausea, vomiting, and diarrhea were the most common adverse events.CONCLUSIONS: The rate of a sustained virologic response 12 weeks after the completion of therapy was 52 to 69% among patients who received interferon-free treatment with faldaprevir in combination with deleobuvir plus ribavirin. (Funded by Boehringer Ingelheim; SOUND-C2 ClinicalTrials.gov number, NCT01132313.).
KW - Adult
KW - Antiviral Agents
KW - DNA-Directed RNA Polymerases
KW - Enzyme Inhibitors
KW - Female
KW - Genotype
KW - Hepacivirus
KW - Hepatitis C, Chronic
KW - Humans
KW - Male
KW - Middle Aged
KW - Oligopeptides
KW - Protease Inhibitors
KW - Thiazoles
KW - Viral Load
U2 - 10.1056/NEJMoa1213557
DO - 10.1056/NEJMoa1213557
M3 - SCORING: Journal article
C2 - 23944300
VL - 369
SP - 630
EP - 639
JO - NEW ENGL J MED
JF - NEW ENGL J MED
SN - 0028-4793
IS - 7
ER -
