Abstract | BACKGROUND: The aim of this study was to document in real life the characteristics and management of hepatitis C patients treated with pegylated interferon-α2a and ribavirin, and the efficacy of treatment (sustained virological response [SVR]). METHODS: This observational study enrolled hepatitis C patients initiating pegylated interferon-α2a and ribavirin treatment. RESULTS: A total of 2,066 patients were included, of which 70% were treatment-naive, 53% had genotype (G) 1 and 38% G2 or G3 infection, and 35% had an F3-F4 Metavir score. In total, 18% of patients treated for 24 weeks and 39% of patients treated for 48 weeks prematurely stopped treatment, mainly because of side effects. The SVR rate (intent-to-treat population) was 39%: 43% in naive patients and 31% in treatment-failure patients. In the complete case analysis population, this was 49%: 54% in naive patients and 37% in treatment-failure patients. Among naive patients, the SVR rate was 42% in G1 carriers and 69% in G2 or G3 carriers. The SVR rate was 69% in naive G1 patients without fibrosis (F0; versus 44% in F1-F2 versus 31% in F3-F4; P<0.001). In naive patients, G2 or G3, low viral load (<800,000 IU/ml) and age ≤40 years were predictive factors for SVR. In treatment-failure patients, low viral load, no or low fibrosis stage (F0-F1) and no treatment modification were predictive factors of SVR. CONCLUSIONS: In patients treated in a real-life setting, adherence to therapy, SVR rates, predictive factors of SVR and safety results were close to those observed in randomized trials. A high SVR in G1 naive patients with no fibrosis warrants further study and might suggest earlier treatment.
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Authors | Marc Bourlière, Denis Ouzan, Michel Rosenheim, Michel Doffoël, Patrick Marcellin, Jean-Michel Pawlotsky, Laurence Salomon, Francis Fagnani, Stéphanie Rouanet, Alexandrina Pinta, Muriel Vray |
Journal | Antiviral therapy
(Antivir Ther)
Vol. 17
Issue 1
Pg. 101-10
( 2012)
ISSN: 2040-2058 [Electronic] England |
PMID | 22267474
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antiviral Agents
- Biomarkers, Pharmacological
- Interferon-alpha
- RNA, Viral
- Recombinant Proteins
- Polyethylene Glycols
- Ribavirin
- peginterferon alfa-2a
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Topics |
- Adult
- Age Factors
- Antiviral Agents
(administration & dosage, adverse effects)
- Biomarkers, Pharmacological
(analysis)
- Cohort Studies
- Female
- France
- Genotype
- Hepacivirus
(drug effects, genetics)
- Hepatitis C, Chronic
(drug therapy, pathology, virology)
- Humans
- Interferon-alpha
(administration & dosage, adverse effects)
- Male
- Middle Aged
- Observation
- Polyethylene Glycols
(administration & dosage, adverse effects)
- RNA, Viral
(biosynthesis)
- Recombinant Proteins
(administration & dosage, adverse effects)
- Ribavirin
(administration & dosage, adverse effects)
- Treatment Outcome
- Viral Load
(drug effects)
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