AASLD: Peg-Interferon and Ifn-Ribavirin Combo Keep HCV in Check Long Term

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AASLD: Peg-Interferon and Ifn-Ribavirin Combo Keep HCV in Check Long Term

By Neil Osterweil, Senior Associate Editor, MedPage Today

Reviewed by Zalman S. Agus, MD; Emeritus Professor at the University of

Pennsylvania School of Medicine.

November 16, 2005

MedPage Today Action Points

Inform patients that a combination of pegylated interferon alfa-2a and

ribavirin appears to be successful in a majority of patients with HCV

infection at keeping the virus in check long after treatment has ended.

This study was published as an abstract and presented orally at a

conference. These data and conclusions should be considered to be

preliminary as they have not yet been reviewed and published in a

peer-reviewed publication.

Review

MD President AASLD

SAN FRANCISCO, Nov. 16 - Treatment with pegylated interferon alfa-2a alone

or in combination with ribavirin (Copegus) produces durable sustained

virologic responses (SVR) in patients treated for hepatitis C infection,

according to a long-term follow-up.

A study of 901 patients treated with pegylated interferon alfa-2a (Pegasys),

or with the Copegus combination during phase III trials found that up to

five years out, 99.2% of patients have remained HCV RNA-negative.

So reported Mark G. Swain, M.D. of the University of Calgary in Alberta and

colleagues in Asia, North America, Australia, and France at the American

Society for the Study of Liver Diseases meeting here.

Overall, the Copegus combination has produced SVR rates up to 60% in

patients with HCV infection alone, and 40% in patients with HCV and HIV

co-infection. But how durable those response rates were has been uncertain.

" The durability of an SVR after interferon-based treatment for chronic

hepatitis C is an important question that can only be addressed by following

patients for a protracted period of time with periodic serum HCV RNA

testing, " the investigators said in a poster presentation.

That's what they did in an effort to quantify the long-term durability of

responses after treatment with Pegasys alone or in the Copegus regimen.

Patients in the study were those who took part in multicenter randomized

phase III trials of either Pegasys monotherapy or one of four studies of the

combination. These included one trial that was conducted in patients with

consistently normal alanine aminotransferase (ALT) levels and one including

only patients with HCV-HIV coinfection (the APRICOT trial).

As many as 20% of patients with HCV and normal ALT values may develop

fibrosis, and 10% may progress to advanced liver disease, other studies have

suggested.

Patients had to have achieved an SVR, defined as HCV RNA undetectable in

serum (50 IU/mL) at the end of a 24-week follow-up phase in all trials.

Patients could not have had any other therapy for hepatitis C following the

end of the trial.

All patients underwent annual HCV RNA testing with quantitative polymerase

chain reaction (PCR) assay.

A total of 901 patients were available for follow-up, 186 of whom had

received Pegasys monotherapy, and 715 of whom had received the combination.

The investigators found that 894 of the 901 patients (99.2%) have remained

HCV-RNA negative throughout the follow-up period, including all patients who

had been treated for 48 weeks with Pegasys plus standard dose ribavirin

(1,000 or 1,200 mg/day).

In addition, all patients with consistently normal ALT levels and all of

those co-infected with HCV and HIV continue to be HCV RNA negative, the

authors said.

" Our results demonstrate that SVR, as defined by a commercial HCV RNA assay,

is long lasting, and that clinical relapse is extremely rare in patients who

are 'cured' of chronic hepatitis C, " the authors said.

They said that it has not yet been determined whether the seven patients who

were found to be HCV RNA positive during follow-up had a relapse of the

original infection or were re-infected by a different strain.

Primary source: AASLD Annual Meeting

Source reference:

Swain MG et al. Sustained Virological Response (SVR) is Durable After

Treatment With Peginterferon Alfa-2a (40KD) (PEGASYS) Alone or in

Combination With Ribavirin (COPEGUS): Results of an Ongoing Long-term

Follow-up Study. Abstract 1148, presented Nov. 15.

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