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Standard versus higher induction doses of peginterferon alfa-2a (40KD) and/or higher ribavirin (RBV) in HCV G1 patients with high viral load and body weight ≥85 kg: Final results of the PROGRESS study
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Reported by Jules Levin
AASLD Oct 30-Nov3 2009, Boston, MA
K. Rajender Reddy*, Mitchell L. Shiffman, Maribel Rodriguez-Torres, Djamal Abdurakhmanov, Igor Bakulin, Giovanni Faria Silva, Hugo Cheinquer, Michael Rabbia, Jean Depamphilis, Michael McKenna, Stephen A. Harrison
*Division of Gastroenterology, University of Pennsylvania, Philadelphia, PA, USA
from Jules: this study did not find high dose induction Pegasys+ribavirin provided higher SVR rates except ir did in patients with steatosis (NAS score>/=3) and for patients over 95 kg in body weight. After the oral presentation Jay Hoofnagle went to the microphone and said these results put to bed any notion that high dose pegINF can improve SVR rates in difficult to treat patients. I totally disagree. This study does not settle the question. This study did not report adherence data, perhaps patients who completely adhered to regimen would have had better responses, since we know side effects can be worse at higher dose. The concept of high dose peginf is an important one for nonresponders and difficult to treat patients and deserves a better study. Several years ago early studies on this question suggested better responses using higher doses so this study should have been better designed to address the adherence question. My feeling is that with good adherence higher dose peg/RBV would provide better SVR rates.
RVR = rapid virologic response (<15 IU/mL HCV RNA at week 4)
cEVR = complete early virologic response (<15 IU/mL HCV RNA at week 12)
EOT = end-of-treatment (<15 IU/mL HCV RNA at week 48)
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