| Albuferon Demonstrates
Promising Antiviral Activity in Prior Non-Responders David
Nelson, MD, of Human Genome Sciences presented safety and efficacy date for high-dose
albumin interferon alfa-2b (Albuferon) in prior treatment non-responders at the
Digestive Disease Week 2006 conference in May. Albuferon is a novel recombinant
protein consisting of interferon alfa fused to human albumin.
In this
ongoing Phase II dose-ranging study, 115 prior non-responders to therapy with
either conventional or pegylated interferon (defined as failure to achieve early
virological response, that is, undetectable HCV viral load or at least a 2 log
reduction in HCV RNA after 12 weeks of therapy) were randomly assigned to receive
the following doses of Albuferon by subcutaneous injection, in combination with
1000-1200 mg daily ribavirin:
 | 900
mcg once every two weeks | |
1200 mcg once every two weeks | | 1200
mcg once every four weeks
| | After
safety data were evaluated for these groups, two higher-dose cohorts were enrolled: | | 1500
mcg once every two weeks | | 1800
mcg once every two weeks |
|
Results
48-week
data were available for the 3 lower-dose groups, 24-week data for the 1500 mcg
group, and 12-week data for the 1800 mcg group.
| After
12 weeks, virological response was greatest in the 1800 mcg cohort (HCV RNA decrease
of 3.7 logs), despite this group having a larger proportion of prior pegylated
interferon/ribavirin nonresponders. | | Among
genotype 1 pegylated interferon/ribavirin nonresponders, the slope of 4-12 week
decline in HCV RNA was significantly more rapid for the 1800 mcg cohort compared
with the 900-1500 mcg cohorts (P < 0.01). | | The
proportions of patients with early virological response at 12 weeks ranged from
41% to 59%. | |
Virological response rates at week 24 were comparable across the 900-1500 mcg
groups (25% to 39%). | | Most
patients who had undetectable HCV RNA at week 24 remained negative at week 48
(25% to 35% in the 900-1200 mcg cohorts). | | Virological
response at week 12 and week 24 predicted 48-week end-of-treatment response in
the 900-1200 mcg cohorts. | | Response
rates and magnitude of HCV RNA decline were similar in the 1200 once every two
weeks and once every four weeks cohorts. |
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