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New Pegasys Study data: 43% of non-responders have histological improvement
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Reported by Jules Levin
Bangkok International AIDS Conference
July 11-16, 2004
At today's Pegasys satellite symposium, Roche presented for the first time histological results on patients from the APRICOT study. The APRICOT study was the largest and only international registration coinfection treatment study (750 patients), in which patients were randomized to receive Pegasys plus ribavirin 800 mg daily (Copegus), interferon plus ribavirin (Copegus) or Pegasys plus placebo. Patients were treated for 48 weeks and there was a 24-week followup period.
The sustained viral response (SVR) was 40% for patients receiving Pegasys plusribavirin; for patients with genotype 1, 29% (Pegasys+Copegus) versus 7% (interferon+Copegus) had SVR. For genotype 2/3 62% (Pegasys+Copegus) vs 20% had SVR. Overall SVR was significantly higher for patients receiving Pegasys monotherapy compared to patients receiving interferon plus Copegus (20% vs 12%). Pegasys monotherapy may be used in patients who cannot tolerate ribavirin. The relapse rate was low in patients treated with Pegasys plus Copegus. (<15%). 40% SVR is the highest of any reported study in HCV/HIV coinfection.
Biopsies were obtained 15 months or less prior to treatment in APRICOT and 56 or more days post-treatment. The biopsies were evaluated by local pathologist using the Ishak Modified Histological Activity Index (HAI) Scoring System. Cirrhotic category includes: F6 (probable or definite cirrhosis); F5 or F4 (incomplete cirrhosis, marked bridging (>3 bridges) and/or nodules. Histologic response = 2-point or more decrease in HAI score.
HISTOLOGIC RESPONSE
Interferon plus Copegus- 47%
Pegasys plus placebo - 39%
Pegasys plus Copegus- 57%
CORRELATION BETWEEN HISTOLOGICAL RESPONSE AND VIROLOGIC RESPONSE
Pegasys plus Copegus:
--69% of patients with SVR had histologic response
--43% of non-responders had histologic response
Pegasys plus placebo:
--30% of non-responders had histologic response
--62% with SVR had histologic response
interferon plus Copegus:
--74% with SVR had histologic response
--32% of non-responders had histologic response
CHANGE IN HISTOLOGIC DISEASE STAGE IN VIROLOGIC NON-RESPONDERS
Pegasys plus Copegus:
--43% showed histologic improvement
--34% showed no change
--23% worsened
Pegasys plus placebo:
--30% showed improvement
--36% showed no change
--34% worsened
interferon plus Copegus:
--32% showed improvement
--43% showed no change
--25% worsened
Using a multiple logistical regression analysis, two factors predicted sustained viral response: genotype non-1; HCV RNA <800,000 IU/ml
98%-100% of co-infected patients who did not have an early virologic response by week 12 (2 log reduction in HCV RNA or undetectable) did not achieve SVR (Negative Predictive Value). Overall, 56% of patients with EVR by week 12 after initiating Pegasys plus RBV achieved SVR (Positive Predictive Value). For genotype 1, PPV was 45% for patients with EVR by week 12; for genotype 2/3, PPV was 70% for patients with EVR by week 12.
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