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In Patients Who Clear HCV RNA At Week 12 (between week 8 and 12): SVR is Higher After 72 Weeks Than After 48 Weeks Treatment: Results of a Randomized Controlled Trial
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Reported by Jules Levin
EASL, April 11-15, 2007
Barcelona, Spain
Alessandra Mangia from Italy looked at genotype 1 patients and reported patients who did not achieve HCV-RNA negativity until week 12 had higher SVR rates with 72 weeks of therapy than with 48 weeks of therapy (63% [n=33] vs 37% [n=7]). She said the results approached statistical significance, p=0.06. She said the main reason for failure was the high relapse rate in the 48 week group. The relapse rate was lower for the patients receiving 72 weeks (13%) than for patients receiving 48 weeks (26%). She said the rate of drop out was comparable between the two groups. The discontinuation rate was higher for patients receiving 72 weeks (23%) vs those receiving 48 weeks (16%). Of note, she said "a slower response was observed in older patients". She also said treatment duration was the only independent predictor I think she said in both the univariate & multivariate analysis (p=0.06). This was a prospective study of 694 treatment-naive patients receiving "variable" duration of therapy-- 24, 48, or 72 weeks peginterferon plus ribavirin (1000-1200mg/day), to better define, among genotype 1 patients without RVR (Rapid Viral Response, week 4), those who benefit from extended duration of therapy. In the variable treatment arm patients with an RVR stopped treatment at week 24; patients who were HCV RNA positive (PCR by 50 Iu/mL) at week 4 continued until week 48; and patients who were positive at week 8 continued treatment until week 72. 459 patients received "variable" duration of therapy while 235 patients received standard 48 weeks therapy. Most study patients (60-65%) had fibrosis stage <3 and 75% < grade 3. In total 184 patients were HCV RNA negative at week 4, 122 in the variable group and 78% of these achieved SVR; 62 were HCV RNA negative at week 4 in the standard treatment group and 87% achieved SVR. 192 patients in total were HCV RNA negative at week week, 128 in the variable arm and 64 in the standard arm. 72% in the variable arm achieved SVR and 70% in the standard arm achieved SVR.
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