Human Genome Sciences, Inc. today announced the final results of a Phase 2b clinical trial of the investigational drug, Albuferon (albinterferon alfa-2b), in combination with ribavirin in therapy-naive patients with genotype 1 chronic hepatitis C. This Phase 2b study demonstrated that, with half as a number of injections as Pegasys (peginterferon alfa 2a), Albuferon was just as effective in achieving sustained virologic response (SVR) an undetectable amount of virus in the blood at 24 weeks following the end of therapy with comparable safety and less impairment of health-related quality of life on therapy. Albuferon is administered every two weeks, while peginterferon alfa-2a requires administration every week.

The final Phase 2b data are being presented this week at the 58 th AASLD Annual Meeting in Boston. In two additional press releases also issued by HGS today, the Company announced the full presentations at AASLD of quality-of-life data from the Phase 2b trial, and results from the Phase 2 trial of Albuferon in combination with ribavirin in patients with chronic hepatitis C who had not responded to prior interferon-based therapy regimens.

The final Phase 2b results suggest that the every-two-week dosing regimen of Albuferon halves the number of injections that are mandatory with peginterferon alfa-2a, while providing at least comparable efficacy, comparable safety and the potential for less impairment of quality of life and daily activity, said Stefan Zeuzem, M.D., Professor of Medicine and Chief, Department of Medicine, J.W. Goethe University Hospital, Frankfurt, Gera number of. We are continuing the evaluation of the 900-mcg and 1200-mcg doses of Albuferon in larger populations in Phase 3 trials. We also conclude that monthly dosing of Albuferon deserves further evaluation.

In the open-label, multi-center, active-controlled Phase 2b trial, 458 therapy-naive patients with genotype 1 chronic hepatitis C were randomized to four therapy groups: Albuferon 900 mcg every two weeks, Albuferon 1200 mcg every two weeks, Albuferon 1200 mcg every four weeks, and peginterferon alfa-2a 180 mcg once a week. All patients received weight-based oral ribavirin daily. The trial included 48 weeks of therapy, and the primary efficacy endpoint was SVR, defined as undetectable viral load (HCV RNA<10 IU/mL) at 24 weeks following completion of therapy.

Assuming that the Phase 2 results are confirmed in Phase 3, we think that Albuferon could become the interferon of choice in combination regimens for the therapy of chronic hepatitis C, said David C. Stump, M.D., Executive Vice President, Research and Development, HGS. Both of our Phase 3 trials have completed enrollment ahead of schedule, and we expect to have Phase 3 data available by spring 2009 to support the filing of global marketing authorization applications by fall 2009.

Key Findings from the Phase 2b Study
Albuferon requires half the number of injections as peginterferon alfa-2a, and the final results of the Phase 2b study demonstrated that Albuferon provided at least comparable efficacy and comparable safety vs. peginterferon alfa-2a (ITT analysis), with less impairment of quality of life on therapy and fewer lost days of work.

The final Phase 2b results include the following SVR rates and other findings:
Albuferon 900-mcg Every Two Weeks (Albuferon 900 Q2w).

Based on an intention-to-treat ( ITT) analysis, 58.5% of patients in the Albuferon 900 Q2w therapy group achieved SVR, vs. 57.9% for peginterferon alfa-2a administered every week.

In heavier patients (>75 kg) who were therapy-adherent, 74.2% of those in the Albuferon 900 Q2w therapy group achie ved SVR , versus 53.3% for peginterferon alfa-2a.

Among all therapy-adherent patients in the Albuferon 900 Q2w therapy group , 72.3% achieved SVR, versus 66.7% for peginterferon alfa-2a.

Based on the SF-36 Health Survey, patients in the Albuferon 900 Q2w therapy group reported less impairment of health-related quality of life, compared with patients in the peginterferon alfa-2a therapy group, as measured by both physical component and mental component SF-36 summary measures at all time-points throughout the 48-week therapy period.

Significantly fewer working patients in the Albuferon 900 Q2w therapy group reported missing 7 days or more of work during the month previous to their visits at Weeks 12 and 24, vs. the peginterferon alfa-2a group (p<.05; Week 12: 4.2% for Albuferon 900 Q2w vs. 18.1% for peginterferon alfa-2a; Week 24: 5.3% for Albuferon 900 Q2w, vs. 20.3% for peginterferon alfa-2a).

The rate of discontinuations due to adverse events was 9.3% in the Albuferon 900 Q2w therapy group, vs. 6.1% in the peginterferon alfa-2a group. Adverse events observed were those typically expected with interferon treatment.

Albuferon 1200-mcg Every Two Weeks (Albuferon 1200 Q2w)
ITT analysis shows that 55.5% of patients in the Albuferon 1200 Q2w therapy group achieved SVR, vs. 57.9% for peginterferon alfa-2a administered every week.

In heavier patients (>75 kg) who were therapy-adherent, 67.9% of those in the Albuferon 1200 Q2w therapy group achie ved SVR, versus 53.3% for peginterferon alfa-2a every week.

Among all therapy-adherent patients in the Albuferon 1200 Q2w therapy group , 70.6% achieved SVR , versus 66.7% for peginterferon alfa-2a.

ITT analysis shows that the Albuferon 1200 Q2w therapy group exhibited a robust early antiviral response (reduction in hepatitis C RNA viral load to below the level of quantitation): 74.5% for Albuferon 1200 Q2w at Week 12, vs. 65.8% for peginterferon alfa-2a. The Albuferon 1200 Q2w therapy group also had the most rapid time to HCV RNA negativity.

The rate of discontinuations due to adverse events was 18.2% in the Albuferon 1200 Q2w therapy group, vs. 6.1% in the peginterferon alfa-2a group. Adverse events observed were those typically expected with interferon treatment. Dose reductions were attempted in only 24.4% of Albuferon subjects previous to discontinuation, versus 42.9% for peginterferon alfa-2a. Adverse events observed were those typically expected with interferon treatment.

In the Albuferon Phase 3 trials, we are strongly encouraging titration of dose where necessary to increase tolerability, reduce the rate of discontinuations, and maximize the therapeutic benefit of the robust early antiviral response offered by the 1200-microgram dose on a two-week administration schedule, said Dr. Stump.

Albuferon 1200-mcg Monthly (Albuferon 1200 Q4w)
ITT analysis shows that 50.9% of patients in the Albuferon 1200 Q4w therapy group achieved SVR, vs. 57.9% for peginterferon alfa-2a administered every week.

In heavier patients (>75 kg) who were therapy-adherent, 61.0% of those in the Albuferon 1200 Q4w therapy group achie ved SVR, versus 53.3% for peginterferon alfa-2a administered once every week.

Among all therapy-adherent patients in the Albuferon 1200 Q4w therapy group, 62.0% achieved SVR, versus 66.7% for peginterferon alfa-2a.

The rate of discontinuations due to adverse events was 12.1% in the Albuferon 1200 Q4w therapy group, vs. 6.1% in the peginterferon alfa-2a group. Adverse events observed were those typically expected with interferon treatment.

The number of patients experiencing severe hematologic adverse events was significantly lower in the Albuferon 1200 Q4w therapy group (10.3%, vs. 20.2% for peginterferon alfa-2a, p<0.05).

Higher doses of Albuferon administered every four weeks, in combination with ribavirin, will be explored in a separate Phase 2b trial conducted by Novartis, which is expected to begin by year-end 2007.


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