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HCV Genotype 1 Patients with High Viral Load Do Better with 48 vs 24 Weeks of Treatment, despite Rapid Virological Response

By Liz Highleyman

In an effort to reduce the side effects and cost of interferon-based therapy for chronic hepatitis C virus (HCV) infection, researchers have explored different dosing regimens and treatment durations.

Current standard-of-care therapy consists of pegylated interferon (Pegasys or PegIntron) plus weight-based ribavirin for 48 weeks in patients with hard-to-treat HCV genotype 1, or 24 weeks in those with genotypes 2 or 3.

Several studies have shown that individuals who experience rapid virological response (RVR) - or undetectable HCV RNA after 4 weeks of therapy - are much more likely to go on to achieve sustained virological response (SVR), leading some investigators to suggest that shorter treatment might be sufficient for rapid responders.

In the current study, researchers from Taiwan assessed whether a treatment duration of 24 weeks would be as effective as a standard 48-week course for genotype 1 patients with RVR.

The study included 200 genotype 1 chronic hepatitis C patients who were randomly assigned (1:1) to receive 180 mcg/week pegylated interferon alfa-2a (Pegasys) plus 1000-1200 mg/day weight-based ribavirin for either 24 or 48 weeks. The primary endpoint was SVR, or continued undetectable HCV RNA 24 weeks after completion of therapy -- generally regarded as a "cure."

Results

Overall, the 48-week treatment arm had a significantly higher SVR rate compared with the 24-week arm (79% vs 59%; P = 0.002).

For 87 patients (43.5%) who achieved RVR, the 48-week arm also had a higher SVR rate than the 24-week arm (100% vs 88.9%; P = 0.056).

For 52 patients with low baseline HCV RNA viremia (< 400,000 IU/mL) and RVR, however, the 24-week arm had an SVR rate of 96.4%, which was comparable to the 100% rate seen in the 48-week arm.

Stated another way, relapse rates after completion of treatment were statistically similar in the low baseline viral load group, whether they were treated for 24 weeks (3.6%) or 48 weeks (0%).

Multivariate analysis of all patients showed that RVR was the strongest independent predictor of SVR, followed by treatment duration, mean weight-based exposure to ribavirin, and baseline HCV viral load.

Based on these findings, the study authors concluded that, "HCV[genotype]-1 patients derive a significantly better SVR from 48 weeks versus 24 weeks of peginterferon/ribavirin even if they attain an RVR."

They added, however, that, "Both 24 and 48 weeks of therapy can achieve high SVR rates (> 96%) in HCV[genotype]-1 patients with low viral loads and an RVR."

Kaohsiung Medical University Hospital, Kaohsiung, Taiwan; Kaohsiung Municipal Hsiao-Kang Hospital, Kaohsiung, Taiwan; Paochien Hospital, Pintung, Taiwan.

7/04/08

Reference
ML Yu, CY Dai, JF Huang, and others. Rapid virological response and treatment duration for chronic hepatitis C genotype 1 patients: a randomized trial. Hepatology 47(6): 1884-1893. June 2008. [ Abstract ]

 

 

 

 







 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


FDA-approved Combination Therapies for Chronic HCV Infection

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PEG-Intron + Rebetol
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