AASLD: Consensus Interferon Plus Ribavirin Gives HCV Patients Second Chance

[Guest guest]

AASLD: Consensus Interferon Plus Ribavirin Gives HCV Patients Second Chance

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

Explain to interested patients that these preliminary studies suggest that

many patients with chronic HCV infection who fail to benefit from therapy

with a pegylated interferon and ribavirin may benefit from consensus

interferon plus ribavirin.

These studies were published as abstracts 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

SAN FRANCISCO, Nov. 16 - Patients with hepatitis C infection who are

refractory to pegylated interferon plus ribavirin or who relapse, may

benefit from additional therapy with consensus interferon plus ribavirin,

two studies suggest.

This don't-give-up message emerged at the meeting of the American

Association for the Study of Liver Disease here from treatment centers in

Dallas and Chicago. Consensus interferon is a non-natural recombinant

interferon that was developed by scanning subtypes of alpha interferon and

assigning the most frequently observed amino acid at each position to form a

consensus molecule.

Investigators found that a majority of non-responding and relapsing patients

achieve early and sustained viral responses (SVR) when treated with daily

consensus interferon (interferon alfacon-1, or Infergen) and ribavirin.

In an all-comers study of patients with any HCV genotype who were

non-responders or relapsers on pegylated interferon (peg-IFN) plus ribavirin

therapy, the Dallas researchers found that following therapy with consensus

interferon plus weight-based ribavirin, 65% of non-responders and 95% of

relapsers had early virologic response rates.

These response rates were as measured by a greater than 2-log decrease in

HCV RNA at 12 weeks, according to Reem Ghalib, M.D., and colleagues at the

Methodist Dallas Medical Center.

" These patients deserve another chance, and this is certainly a good chance

for a lot of them, " said Cheryl Levine, Ph.D., an epidemiologist and nurse

practitioner at Methodist, in an interview. " I'm at a transplant center, and

these patients, if they're not on the transplant list, are cirrhotic and

getting close to that, and this is a chance to be free of virus before their

livers fail. "

In the Methodist study, the researchers conducted a retrospective analysis

of patients who were being treated at their clinic, or had been treated

there previously, with consensus interferon plus ribavirin.

The study looked at all patients who had at least 12 weeks of Peg-IFN plus

ribavirin therapy, began treatment with consensus interferon plus ribavirin,

and who either discontinued therapy or completed at least 24 weeks.

The patients received consensus interferon at 15 mcg daily plus ribavirin at

11 mg/kg/day, with treatment planned to last for 48 weeks.

At the 24-week interim analysis, 33% of non-responders and 79% of relapsers

had undetectable viral levels. At the same time, 57% of the non-responders

had a > 2 log decrease in HCV RNA, as did 89% of the relapsers.

The therapy was well tolerated, with 71% continuing treatment beyond 24

weeks.

In the other study, researchers at Loyola University in Chicago found

similar results among patients who were non-responders to therapy with

either standard or pegylated interferon alfa and ribavirin.

Nikunj Shah, M.D., and colleagues looked at 76 patients with chronic HCV who

had failed to respond to therapy with interferon alfa or pegylated

interferon plus ribavirin.

Non-response was defined as a failure to clear HCV RNA. These patients

received consensus interferon at a starting dose of 15 mcg daily, plus

weight-based ribavirin (800-1,200 mg/day) for at least 48 weeks.

All patients had a pretreatment liver biopsy and were evaluated for HCV

genotyping and viral load. The patients were followed for at least 24 weeks

after the last treatment to determine sustained virologic responses.

The authors found that 72% of patients had an end-of-treatment response, and

50% had a sustained virologic response at last follow-up.

The data suggest that consensus interferon plus weight-based ribavirin is a

potential alternative to pegylated IFN plus ribavirin.

" In addition, non-responder patients with advanced disease [fibrosis scores

of 3 or 4] tolerated this therapy well and should be candidates for

retreatment with IFN-alfacon-1 and ribavirin, " the investigators said.

There is an ongoing, phase III multicenter trial (the Direct Trial) that is

evaluating daily subcutaneous interferon alfacon-1 plus ribavirin versus no

treatment in HCV patients who have not responded to previous combination

therapy with pegylated interferon alfa plus ribavirin.

Primary source: 2005 AASLD Meeting

Source reference:

Ghalib R et al. Early Viral Response to Consensus Interferon plus Ribavirin

Therapy in Patients who are Nonresponders or Relapsers to Prior PEG IFN plus

Ribavirin Therapy. Abstract 1242, presented Nov. 14.

Additional source: 2005 AASLD Meeting

Source reference:

Chen K et al. Consensus interferon and ribavirin in patients with chronic

hepatitis C who were nonresponders to prior therapy with either interferon

alfa and ribavirin or pegylated interferon and ribavirin. Abstract 1203

presented Nov. 15.

_________________________________________________________________

Don’t just search. Find. Check out the new MSN Search!

http://search.msn.click-url.com/go/onm00200636ave/direct/01/