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HCV genotype 1 infection: Interferon-free treatment with Faldaprevir in combination with Deleobuvir plus Ribavirin


Interferon-free regimens would be a major advance in the treatment of patients with chronic hepatitis C virus ( HCV ) infection.

In the phase 2b, randomized, open-label trial of Faldaprevir ( a protease inhibitor ) and Deleobuvir ( a nonnucleoside polymerase inhibitor ), investigators randomly assigned 362 previously untreated patients with HCV genotype 1 infection to one of five groups: Faldaprevir at a dose of 120 mg once daily and Deleobuvir at a dose of 600 mg three times daily, plus Ribavirin, for 16, 28, or 40 weeks ( TID16W, TID28W, or TID40W, respectively ); Faldaprevir at a dose of 120 mg once daily and Deleobuvir at a dose of 600 mg twice daily, plus Ribavirin, for 28 weeks ( BID28W ); or Faldaprevir at a dose of 120 mg once daily and Deleobuvir at a dose of 600 mg three times daily, without Ribavirin, for 28 weeks ( TID28W-NR ).

The primary end point was a sustained virologic response 12 weeks after the completion of therapy.

The primary end point was met in 59% of patients in the TID16W group, 59% of patients in the TID28W group, 52% of patients in the TID40W group, 69% of patients in the BID28W group, and 39% of patients in the TID28W-NR group.

The sustained virologic response 12 weeks after the completion of therapy did not differ significantly according to treatment duration or dosage among Ribavirin-containing regimens.
This response was significantly higher with TID28W than with TID28W-NR ( P=0.03 ).

Rates of a sustained virologic response 12 weeks after the completion of therapy were 56 to 85% among patients with genotype 1b infection versus 11 to 47% among patients with genotype 1a infection and 58 to 84% among patients with IL28B CC versus 33 to 64% with non-CC genotypes.

Rash, photosensitivity, nausea, vomiting, and diarrhea were the most common adverse events.

In conclusion, the rate of a sustained virologic response 12 weeks after the completion of therapy was 52 to 69% among patients who received Interferon-free treatment with Faldaprevir in combination with Deleobuvir plus Ribavirin. ( Xagena )

Zeuzem S et al, N Engl J Med 2013; 369:630-639

XagenaMedicine_2013



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