jects with undetectable HCV-RNA at End of Treatment (EOT) and detectable HCV-RNA (≥ 25 IU/mL) at End of Follow-up (EOF) among subjects who were undetectable at EOT and not missing End of Follow-up (EOF) data.
§Includes subjects with missing baseline data regarding cirrhosis as diagnosed by liver biopsy.
In subjects with cirrhosis at baseline, sustained virologic response was higher in those who received treatment with the combination of VICTRELIS with PegIntron and REBETOL for 44 weeks after lead-in therapy with PegIntron and REBETOL (10/24, 42%) compared to those who received RGT (5/16 , 31%).
Sustained Virologic Response (SVR) Based on TW 8 HCV-RNA Results
Table 11 presents sustained virologic response based on TW 8 HCV-RNA results in previously untreated subjects. Fifty-seven percent (208/368) of subjects in the VICTRELIS-RGT arm and 56% (204/366) of subjects in the VICTRELIS-PR48 arm had undetectable HCV-RNA at TW8 (early responders) compared with 17% (60/363) of subjects in the PR48 arm.
Table 11 Sustained Virologic Response (SVR) by HCV-RNA Detectability at TW8 in Previously Untreated Subjects in the Combined Cohort VICTRELIS-RGT VICTRELIS-PR48 PR48
SVR by TW8 Detectability, % (n/N)* N=337 N=335 N=331
Undetectable 88 (184/208) 90 (184/204) 85 (51/60)
Detectable 36 (46/129) 40 (52/131) 30 (82/271)
*Denominator included only subjects with HCV-RNA results at TW8.
Among subjects with detectable HCV-RNA at TW 8 who had attained undetectable HCV-RNA at TW 24 and completed at least 28 weeks of treatment, the SVR rates were 66% (45/68) in VICTRELIS-RGT arm (4 weeks of PegIntron and REBETOL then 24 weeks of VICTRELIS with PegIntron and REBETOL followed by 20 weeks of PegIntron and REBETOL alone) and 75% (55/73) in VICTRELIS-PR48 arms (4 weeks of PegIntron and REBETOL then 44 weeks of VICTRELIS with PegIntron and REBETOL).
Subjects Who Failed Previous Therapy with Peginterferon Alfa and Ribavirin
RESPOND-2 was a randomized, parallel-group, double-blind study comparing two therapeutic regimens of VICTRELIS 800 mg orally three times daily in combination with PR [PegIntron 1.5 µg/kg/week subcutaneously and weight-based ribavirin (600–1400 mg/day orally divided twice daily)] compared to PR alone in adult subjects with chronic hepatitis C (HCV genotype 1) infection with demonstrated interferon responsiveness (as defined historically by a decrease in HCV-RNA viral load greater than or equal to 2-log10 by Week 12, but never achieved SVR [partial responders] or undetectable HCV-RNA at end of prior treatment with a subsequent detectable HCV-RNA in plasma [relapsers]). Subjects with less than 2-log10 decrease in HCV-RNA by week 12 of previous treatment (prior null responders) were not eligible for enrollment in this trial. Subjects were randomized in a 1:2:2 ratio and stratified based on response to their previous qualifying regimen (relapsers vs. partial responders) and by HCV subtype (1a vs. 1b) to one of the following treatment arms:
•PegIntron + REBETOL for 48 weeks (PR48)
•PegIntron + REBETOL for 4 weeks followed by VICTRELIS 800 mg three times daily + PegIntron + REBETOL for 32 weeks. The subjects were then continued on different treatment regimens based on TW8 and TW12 response-guided therapy (VICTRELIS-RGT). All subjects in this treatment arm were limited to 32 weeks of VICTRELIS.
•Subjects with undetectable HCV-RNA at TW 8 (early responders) and TW 12 completed therapy at TW36 |
