Correction: Re: Durability of Pegasys in previous nonresponders - 2/3 yr follow up

[Guest guest]

The CORRECT title should have been Durability of

Pegasys - 2/3 year follow-up of those previously

treated with Pegasys - NOT non-responders! A big

difference!

C

--- claudine intexas <claudineintexas@...>

wrote:

> NATAP - www.natap.org

> ----------------------

>

> AASLD

> Dallas, Nov 9-13

> Reported by Jules Levin

>

> Abstract 633. LONG-LASTING SUSTAINED VIROLOGICAL

> RESPONSE IN CHRONIC HEPATITIS C PATIENTS PREVIOUSLY

> TREATED WITH 40 KDA PEGINTERFERON ALFA-2A (PEGASYS)

>

> Mark Swain, Univ of Calgary, Calgary, AB Canada; E J

> Heathcote, Toronto Western Hosp, Toronto, ON Canada;

> Ming-Yang Lai, National Taiwan Univ Hosp, Taipei

> Taiwan; Bain, Univ of Alberta Hosp,

> Edmonton,

> AB Canada; Victor Feinman, Univ of Toronto, Toronto,

> ON Canada; Sherman, Toronto Gen Hosp,

> Toronto,

> ON Canada; D Kaita, Univ of Manitoba,

> Winnipeg,

> MB Canada; Gane, Auckland Hosp, Auckland New

> Zealand; Kevork Peltekian, Queen Hosp,

> Halifax, NS Canada; , Univ of Southern

> CA, Los Angeles, CA; ph Hoffman, Brunda,

> Hoffmann-La Roche, Nutley, NJ

>

> Background: Treatment of chronic hepatitis C (CHC)

> patients with 40 kDa peginterferon alfa-2a (PEGASYS)

> results in superior antiviral efficacy compared to

> patients treated with interferon alfa-2a (IFN a-2a)

> in

> both a general CHC population and in a population of

> CHC patients with cirrhosis (Zeuzem S et al. N Engl

> J

> Med. 2000;343:1666-1672; Heathcote EJ et al. N Engl

> J

> Med. 2000;343:1673-1680; Pockros PJ et al.

> Hepatology.

> 2000;32(suppl):442A). In these studies, the

> sustained

> virological response was determined at the end of a

> 24-week treatment-free follow-up period. With other

> anti-HCV therapies, long-term virological responses

> have been reported at time points beyond 24 weeks of

> follow-up. To date there has been no long-term

> follow-up on patients who were treated in studies

> evaluating the effects of 40 kDa peginterferon

> alfa-2a.

>

> Objective: To investigate the long-term virological

> effects of treatment with 40 kDa peginterferon

> alfa-2a

> in patients with CHC.

>

> Methods: CHC patients who previously participated in

> one of 3 phase III studies comparing the safety and

> efficacy of 40 kDa peginterferon alfa-2a and IFN

> a-2a

> were included in this study if they had completed

> the

> 24 week follow-up period in the original study.

> Patients could not be on any anti-HCV therapy

> subsequent to their original treatment and were

> tested

> yearly for HCV RNA. All patients were off original

> therapy for 2 to 3 years. HCV RNA was measured using

> AMPLICOR HCV‰ Test v 2.0, with a lower limit of

> detection of 50 IU/mL.

>

> Results: To date, over 300 patients have been

> enrolled

> into the study. Study enrollment and data collection

> are ongoing. Approximately two-thirds of the

> patients

> were originally infected with HCV genotype 1 and 25%

> were cirrhotic. Seventy percent of patients entering

> this trial were treated with 40 kDa peginterferon

> alfa-2a. Patients were evenly divided, with

> approximately 50% of patients being HCV RNA negative

> and 50% HCV RNA positive at the last assessment in

> the

> original protocol.

>

> --Of the patients who were originally HCV RNA

> negative, > 99% remained HCV RNA negative 2 to 3

> years

> after the end of their original therapy.

>

> --In this population, all patients who were of HCV

> genotype 1 or cirrhotic remained HCV RNA negative.

>

> In the patient population that was HCV RNA positive

> at

> the end of follow-up of the original study, all but

> one patient remained HCV RNA positive.

> Interestingly,

> the one patient who became HCV RNA negative was a

> virological responder until week 24 of follow-up in

> the original trial. No HCV RNA could be quantified

> in

> this patient, consistent with the possibility of a

> false positive HCV RNA test at the last evaluation

> in

> the original study.

>

> Conclusions: The sustained virological response

> achieved with 40 kDa peginterferon alfa-2a results

> in

> a durable response in all patients, including those

> with more difficult-to-treat disease (genotype 1 and

> patients with cirrhosis). The data demonstrate that

> CHC patients originally treated with 40 kDa

> peginterferon alfa-2a and were HCV RNA negative at

> the

> end of 24 weeks of treatment-free follow-up remain

> HCV

> RNA negative 2 to 3 years after the end of

> treatment.

> Future evaluations of this patient population will

> determine the long-term effects of 40 kDa

> peginterferon alfa-2a on virological response.

>

>

>

> __________________________________________________

>