Positive Interim Results Of Phase 2b Trial Of Albuferon

Armen Hareyan's picture
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Human Genome Sciences Inc. reported results at Week 12 following the completion of therapy in a Phase 2b clinical trial of Albuferon in combination with ribavirin in patients with genotype 1 chronic hepatitis C who are naive to interferon alpha-based treatment regimens.

The results were presented over the weekend in Barcelona at the 42nd Annual Meeting of the European Association for the Study of the Liver (EASL).

"The interim data presented at EASL suggest that Albuferon may offer efficacy at least comparable to peginterferon alfa-2a, with half the injections and the potential for less impairment of quality of life," said Stefan Zeuzem, M.D., Professor of Medicine and Chief, Department of Medicine, J.W. Goethe University Hospital (Frankfurt, Germany), and a clinical investigator in the Phase 2b trial. "We look forward to continuing the evaluation of Albuferon in larger populations in Phase 3 trials."

The interim results of the Phase 2b trial demonstrated that Albuferon provided at least comparable efficacy vs. Pegasys. The treatment group receiving Albuferon 900-mcg doses every two weeks achieved a 59% rate of sustained virologic response at 12 weeks following completion of therapy (SVR12), vs. 54% for Pegasys administered once every week (ITT analysis). This Albuferon treatment group also had more favorable health-related quality- of-life scores than the Pegasys treatment group. All Albuferon doses provided efficacy at least comparable to Pegasys. Among treatment-adherent patients, 73% of those in the combined groups receiving Albuferon every two weeks achieved SVR12, versus 63% for patients receiving Pegasys once a week.

The interim results of the Phase 2b trial at Week 12 following the completion of therapy include the following virologic response rates (SVR12) and other findings:

Albuferon 900-mcg Every Two Weeks(Albuferon 900 Q2)

-- Based on an intention-to-treat (ITT) analysis, 59% of patients in the Albuferon 900 Q2 treatment group achieved SVR12, vs. 54% for Pegasys administered every week.

-- Among treatment-adherent patients, 74% of those in the Albuferon 900 Q2 treatment group achieved SVR12, versus 63% for Pegasys.

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-- In heavier patients (greater than or equal to 75 kg) who were treatment-adherent, 81% of those in the Albuferon 900 Q2 treatment group achieved SVR12, versus 57% for Pegasys.

-- Based on the SF-36 Heath Survey, patients in the Albuferon 900 Q2 treatment group reported less impairment of health-related quality of life, compared with patients in the Pegasys treatment group, as measured by both physical component and mental component SF-36 summary measures at all time-points throughout the 48-week treatment period.

-- At Weeks 12 and 24, fewer working patients in the Albuferon 900 Q2 treatment group reported missing 7 days or more of work during the previous month, vs. the Pegasys group (Week 12: 4% for Albuferon 900 Q2 vs. 17% for Pegasys; Week 24: 5% for Albuferon 900 Q2, vs. 22% for Pegasys).

-- The rate of discontinuations due to adverse events was 9% in the Albuferon 900 Q2 treatment group, vs. 6% in the Pegasys group.

"The 900-mcg Albuferon dose has the potential to offer patients an attractive therapeutic option, given the favorable antiviral response data, more favorable quality of life effects, and half as many injections," said David C. Stump, M.D., Executive Vice President, Research and Development, HGS.

Albuferon 1200-mcg Every Two Weeks (Albuferon 1200 Q2)

-- ITT analysis shows that 56% of patients in the Albuferon 1200 Q2 treatment group achieved SVR12, vs. 54% for Pegasys administered every week.

-- Among treatment-adherent patients, 72% of those in the Albuferon 1200 Q2 treatment group achieved SVR12, versus 63% for Pegasys.

-- In heavier patients (greater than or equal to 75 kg) who were treatment-adherent, 70% of those in the Albuferon 1200 Q2 treatment group achieved SVR12, versus 57% for Pegasys every week.

-- ITT analysis shows that the Albuferon 1200 Q2 treatment group exhibited a robust early antiviral response (reduction in hepatitis C RNA viral load to below the level of quantitation): 75% for Albuferon 1200 Q2 at Week 12, vs. 66% for Pegasys.

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