The results below are from a study of faldaprevir
(HCV protease inhibitor (QD=once-a-day)) plus deleobuvir (HCV
polymerase inhibitor (TID=three times a day)). There were 5 different
treatment arms: 4 groups that included ribavirin along with the study
drugs and one group with the study drugs, but without ribavirin.
Treatment duration was 16, 28, or 40 weeks.
The SVR12 rates were similar
between the groups except there was a higher rate of SVR12 in the
groups that received ribavirin compared to the group that did not
But when you breakdown the SVR12 results by HCV genotype subtype:
—a significant difference in SVR12 results between subtypes.
Side effects: rash, photosensitivity (sensitive to light), nausea, vomiting, and diarrhea
This interferon-free regime had
impressive results for HCV genotype 1a. However, HCV genotype 1b SVR 12
rates were much lower. Unfortunately, ribavirin will still be part
of the mix in this treatment regime.
This combination (with ribavirin)
is now in phase 3 clinical trials and it was announced last week that
the phase 3 trial had been completely enrolled. -AF
N Engl J Med.
2013 Aug 15;369(7):630-9. doi: 10.1056/NEJMoa1213557.
Faldaprevir and deleobuvir for HCV genotype 1 infection.
Zeuzem S, Soriano V, Asselah T, Bronowicki JP,
Lohse AW, Müllhaupt B, Schuchmann M, Bourlière M, Buti M, Roberts SK,
Gane EJ, Stern JO, Vinisko R, Kukolj G, Gallivan JP, Böcher WO, Mensa
Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany. firstname.lastname@example.org
Interferon-free regimens would be a major advance
in the treatment of patients with chronic hepatitis C virus (HCV)
In this phase 2b, randomized, open-label trial of
faldaprevir (a protease inhibitor) and deleobuvir (a nonnucleoside
polymerase inhibitor), we 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.
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. (Funded by Boehringer Ingelheim; SOUND-C2
ClinicalTrials.gov number, NCT01132313.).
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