Telaprevir with peginterferon and ribavirin for treatment-naive patients chronically infected with HCV of genotype 1 in Japan.

Abstract

BACKGROUND & AIMS:

To evaluate the efficacy and safety of telaprevir in combination with peginterferon-α2b (PEG-IFN) and ribavirin (RBV) in patients with chronic hepatitis C.

METHODS:

In a multi-center randomized clinical trial in Japan, on patients infected with HCV of genotype 1, 126 patients were assigned to telaprevir for 12 weeks along with PEG-IFN and RBV for 24 weeks (Group A), while 63 to PEG-IFN and RBV for 48 weeks (Group B).

RESULTS:

HCV RNA disappeared more swiftly in patients in Group A than B, and the frequency of patients without detectable HCV RNA at week 4 (rapid virological response (RVR)) was higher in Group A than B (84.0% vs. 4.8%, p <0.0001). Grade 3 and 4 skin disorders, including Stevens-Johnson syndrome and drug rashes with eosinophilia and systemic symptoms, as well as Grade 3 anemia (<8.0 g/dl), occurred more frequently in Group A than B (skin disorders, 11.9% vs. 4.8%; anemia, 11.1% vs. 0.0%). The total RBV dose was smaller in Group A than B (47.0% vs. 77.7% of the target, p <0.0001). Despite these drawbacks, sustained virological response (SVR) was achieved more frequently in Group A than B (73.0% vs. 49.2%, p=0.0020).

CONCLUSIONS:

Although the triple therapy with telaprevir-based regimen for 24 weeks resulted in more adverse events and less total RBV dose than PEG-IFN and RBV for 48 weeks, it was able to achieve higher SVR within shorter duration by carefully monitoring adverse events and modifying the RBV dose as required.

• Authors: Hiromitsu Kumada, Joji Toyota, Takeshi Okanoue, Kazuaki Chayama, Hirohito Tsubouchi, Norio Hayashi
• Journal: Journal of hepatology (J Hepatol) Vol. 56 Issue 1 Pg. 78-84 (Jan 2012) ISSN: 1600-0641 [Electronic] Netherlands
• PMID: 21827730 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2011. Published by Elsevier B.V.

Chemical References

• Antiviral Agents
• Interferon alpha-2
• Interferon-alpha
• Oligopeptides
• RNA, Viral
• Recombinant Proteins
• Polyethylene Glycols
• Ribavirin
• telaprevir
• peginterferon alfa-2b

Topics

• Adult
• Aged
• Antiviral Agents (administration & dosage, adverse effects)
• Cohort Studies
• Drug Eruptions (etiology)
• Drug Therapy, Combination
• Female
• Genotype
• Hematologic Diseases (chemically induced)
• Hepacivirus (genetics)
• Hepatitis C, Chronic (drug therapy, virology)
• Humans
• Interferon alpha-2
• Interferon-alpha (administration & dosage, adverse effects)
• Japan
• Male
• Middle Aged
• Oligopeptides (administration & dosage, adverse effects)
• Polyethylene Glycols (administration & dosage, adverse effects)
• Prospective Studies
• RNA, Viral (metabolism)
• Recombinant Proteins (administration & dosage, adverse effects)
• Ribavirin (administration & dosage, adverse effects)
• Treatment Outcome
• Young Adult