Patients in Europe with chronic hepatitis C who are not responding to therapy may soon have access to another treatment option, after European regulators recommended Schering-Plough’s PegIntron/Rebetol combination for retreating patients who have previously failed to achieve a response.

Specifically, the European Medicines Agency’s Committee for Medicinal Products for Human Use has given the thumbs up for approval of the PegIntron (peginterferon alfa-2b) and Rebetol (ribavirin) combo for retreating adult patients whose prior therapy with interferon alpha and ribavirin or interferon alpha monotherapy did not result in a sustained response.

If the European Commission follows the CHMP’s advice and issues a green light, then the combination will be the only available hepatitis C therapy in the European Union indicated for retreatment of prior treatment failures, Schering-Plough claims.

“A large and growing number of patients whose previous hepatitis C therapy did not result in a sustained response are in need of viable treatment options today," commented Robert Spiegel, chief medical officer and senior vice president of the Schering-Plough Research Institute. “Upon EU approval of this new indication, PegIntron combination therapy will help address this serious unmet medical need,” he stressed.

EPIC data

The CHMP’s positive opinion is based on clinical data from an ongoing study (EPIC3) in which 1,336 patients who failed previous therapy were retreated with PegIntron combination therapy. Importantly, virological response at week 12 of treatment was shown to be an important predictor for achieving a sustained virological response, with 57% of patients who had undetectable virus levels at week 12 going on to achieve SVR with a 48-week course of therapy, the company said.

“The ability with PEGINTRON to help predict efficacy of retreatment early in the course of therapy would assist physicians in managing this hard-to- treat patient population," said Thierry Poynard, professor of medicine, University of Paris VI, Hopital Pitie-Salpetriere, Paris, and a lead investigator of the trial. "Patients with undetectable virus at week 12 have an even chance of success regardless of whether they failed previous therapy with pegylated or non-pegylated interferon and are motivated to continue treatment, and those patients who fail to achieve an early response can have their therapy stopped with confidence," he explained.

PegIntron and Rebetol combination therapy is currently approved in the EU for treatment naïve chronic hepatitis C patients, including those with clinically stable HIV coinfection.