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High sustained virologic response rates in rapid virologic response patients in the large real‐world PROPHESYS cohort confirm results from randomized clinical trials
Author(s) -
Marcellin Patrick,
Cheinquer Hugo,
Curescu Manuela,
Dusheiko Geoffrey M.,
Ferenci Peter,
Horban Andrzej,
Jensen Donald,
Lengyel Gabriella,
Mangia Alessandra,
Ouzan Denis,
Puoti Massimo,
RodriguezTorres Maribel,
Shiffman Mitchell L.,
Schmitz Manuela,
Tatsch Fernando,
Rizzetto Mario
Publication year - 2012
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.25892
Subject(s) - ribavirin , medicine , cohort , confidence interval , hepatitis c virus , gastroenterology , genotype , titer , virology , virus , biology , biochemistry , gene
The ability to predict which patients are most likely to achieve a sustained virologic response (SVR) with peginterferon/ribavirin would be useful in optimizing treatment for hepatitis C virus (HCV). The objective of this large international noninterventional cohort study was to investigate the predictive value (PV) of a virologic response (VR) by weeks 2, 4, and 12 of treatment on SVR. Treatment‐naive HCV monoinfected patients (N = 7,163) age ≥18 years were prescribed peginterferon/ribavirin at the discretion of the treating physician according to country‐specific requirements in accordance with the local label. The main outcome measure was the PV of a VR (HCV RNA <50 IU/mL) by weeks 2, 4, and 12 of treatment for SVR24 (HCV RNA <50 IU/mL after 24 weeks of untreated follow‐up) by HCV genotype. The overall SVR24 rate was 49.4% (3,541/7,163; 95% confidence interval [CI]: 48.3‐50.6%). SVR24 rates in patients with an HCV RNA titer <50 IU/mL by weeks 2, 4, and 12, respectively, were 66.2% (95% CI: 60.4‐71.7%), 68.4% (95% CI: 65.7‐71.0%), and 60.3% (95% CI: 58.5‐62.1%) among genotype 1 patients; 82.0% (95% CI: 76.8‐86.5%), 76.3% (95% CI: 73.3‐79.1%), and 74.2% (95% CI: 71.3‐76.9%) among genotype 2 patients; 67.3% (95% CI: 61.1‐73.1%), 67.3% (95% CI: 64.2‐70.3%), and 63.8% (95% CI: 61.0‐66.6%) among genotype 3 patients; and 59.4% (95% CI: 40.6‐76.3%), 63.3% (95% CI: 54.3‐71.6%), and 54.3% (95% CI: 47.5‐60.9%) among genotype 4 patients. The absence of a VR by week 12 had the highest negative PV across all genotypes. Conclusion: A VR by week 2 or 4 had the highest positive PV for SVR24 and differed according to HCV genotype. (H EPATOLOGY 2012;56:2039–2050)