12 Weeks of Peginterferon Alfa-2b (PegIntron) and Ribavirin Combination Therapy Shown as Effective as 24 Weeks of Treatment in HCV Patients with Genotype 2 or 3 Virus Who Had an Early Virological Response to Therapy

Results of a new Italian study published in the current issue of the New England Journal of Medicine show that a shorter, 12-week course of therapy with peginterferon alfa-2b (PegIntron) and ribavirin combination therapy was as effective as a 24-week course for patients with hepatitis C virus (HCV) genotype 2 or 3 who had an early virological (EVR) to treatment.

“Early Virologocal Response” is defined as HCV RNA undetectable (negative) after  4 weeks of therapy.

The shorter regimen was not only highly effective in these patients, with 85 percent achieving a sustained virological response (SVR), but it also was associated with fewer side effects and, consequently, less frequent withdrawals from therapy.

In addition, patients assigned to 12 weeks of treatment were less likely to require a dose reduction. Maintaining the therapeutic dose is important for achieving a sustained virological response.

This open-label clinical trial was conducted in 14 centers in Italy as an investigator-sponsored study without financial support from industry.

“Our findings suggest that patients with chronic hepatitis C genotype 2 or 3 infection who have undetectable virus after 4 weeks of treatment with peginterferon alfa-2b and ribavirin achieve high response rates with only 12 weeks of therapy and do not require 24 weeks of treatment,” said Alessandra Mangia, M.D., Gastroenterology Unit, IRCCS Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo.

“Tailoring treatment so that those with an early response are given a shorter course may make therapy more appealing to patients, sparing the expense and inconvenience of extended treatment, without adversely affecting outcomes,” noted Dr. Mangia.

Most patients treated today for chronic HCV genotype 2 or 3 receive 24 or 48 weeks of therapy. Although these schedules are effective, side effects increase with the length of treatment.

Abstract from the NEJM Article:

Researchers hypothesized that in patients with hepatitis C virus (HCV) genotype 2 or 3 in whom HCV RNA is not detectable after 4 weeks of therapy, 12 weeks of treatment is as effective as 24 weeks.

A total of 283 patients were randomly assigned to a standard 24-week regimen of peginterferon alfa-2b at a dose of 1.0 µg per kilogram weekly plus ribavirin at a dose of 1000 mg or 1200 mg daily, on the basis of body weight.

Of these, 70 patients were assigned to the 24-week regimen (standard-duration group) and 213 patients to a variable regimen (variable-duration group) of 12 or 24 weeks, depending on whether tests for HCV RNA were negative or positive at week 4.

The primary end point was HCV that was not detectable by polymerase-chain-reaction (PCR) assay 24 weeks after the completion of therapy.

Results

·  In the standard-duration group, 45 (64 percent) patients had HCV that was not detectable by PCR assay at week 4, as compared with 133 (62 percent) in the variable-duration group (difference [the rate in the standard-duration group minus that in the variable-duration group], 2 percent; 95 percent confidence interval, –11 to 15 percent).

·  Fifty-three patients (76 percent) in the standard-duration group and 164 patients (77 percent) in the variable-duration group had a sustained virologic response (difference, –1 percent; 95 percent confidence interval, –13 to 10 percent).

· Fewer patients in the variable-duration group receiving the 12-week regimen had adverse events and withdrew than in the group receiving the 24-week regimen (P=0.045).

· The rate of relapse (defined as HCV not detectable at the end of treatment but detectable at the end of follow-up) was 3.6 percent in the standard-duration group and 8.9 percent in the variable-duration group (P=0.16).

· Overall, the rate of sustained virologic response was 80 percent among patients with HCV genotype 2 and 66 percent among those with genotype 3 (P<0.001).

In conclusion, the authors write, “A shorter course of therapy over 12 weeks with peginterferon alfa-2b and ribavirin is as effective as a 24-week course for patients with HCV genotype 2 or 3 who have a response to treatment at 4 weeks.”

06/24/05

Reference
A Mangia and others. Peginterferon Alfa-2b and Ribavirin for 12 vs. 24 Weeks in HCV Genotype 2 or 3. The New England Journal of Medicine 352(25): 2609-2617. June 23, 2005.

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