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Early Clearance of HCV RNA in HCV Genotype 1 Treatment-na•ve Patients Treated with Telaprevir, Peginterferon and Ribavirin:
Pooled Analysis of the Phase 3 Trials ADVANCE and ILLUMINATE
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Reported by Jules Levin
CROI 2011 March 2 Boston
KE Sherman1, GT Everson2, IM Jacobson3, AM Di Bisceglie4, DR Nelson5, L Bengtsson6, N Adda6, RS Kauffman6, CI Wright6, and S Zeuzem7
1University of Cincinnati College of Medicine, Cincinnati, OH, USA; 2University of Colorado Denver, Aurora, CO, USA; 3Weill Cornell Medical College, New York, NY, USA; 4Saint Louis University School of Medicine, Saint Louis, MO, USA; 5University of Florida, Gainesville, FL, USA;
6Vertex Pharmaceuticals Incorporated, Cambridge, MA, USA; 7Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany
"6%, 22%, and 20% of T12PR patients had undetectable HCV RNA at Week 1, Week 2, and Week 4, respectively, compared to 2%, 3%, and 3% of patients in PR, respectively (Figure 2A)."
"70%, 63% and 73% of T12PR patients achieved RVR, eRVR, and SVR compared to 9%, 8%, and 44% of PR patients, respectively (Figure 2B)." (from Jules: In ADVANCE 75% with 12 weeks telaprevir achieved SVR & 69% who took 8 weeks telaprevir)
"Patients treated with a telaprevir-based regimen, who had early
HCV RNA undetectability, had higher sustained viral response rates
ÐÐ 90% of patients, with undetectable HCV RNA at Week 1,
achieved a sustained viral response rate compared to 83%
and 77% in Week 2 and Week 4 first undetectable HCV RNA
patients."
"A majority of patients treated with a telaprevir-based regimen received 24 weeks of total treatment while all patients treated
with peginterferon alfa-2a/ribavirin alone received 48 weeks of total treatment"
"Overall 7% (66/903) of T12PR patients experienced virologic failure versus 32% (115/361) of PR patients."
"Overall 8% (64/903) of T12PR patients experienced relapse versus 28% (64/361) of PR patients (Table 2)."
"Most common adverse events reported in T12PR patients ³10% difference from PR patients were pruritus, nausea, anemia, and rash (in bold, Table 3)."
"During the telaprevir treatment phase, 7% and 4% of T12PR and PR patients discontinued all study drugs including 1% and 1% of T12PR and 0% and 1% of PR patients due to rash and anemia events, respectively."
"During the overall treatment phase, 14% and 7% of T12PR and PR patients discontinued all study drugs including 2% and 2% of T12PR and 0% and 1% of PR patients due to rash and anemia events, respectively."
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