Daclatasvir vs telaprevir plus peginterferon alfa/ribavirin for hepatitis C virus genotype 1

Table 2 Efficacy endpoints and failures in GT1b-infected patients

Outcome, n/n (%)	DCV + pegIFN/RBV	TVR + pegIFN/RBV
Efficacy
SVR12 (mITT)12	228/268 (85.1)	109/134 (81.3)
SVR12 on or after PT week 123	230/268 (85.8)	110/134 (82.1)
RVR (HCV-RNA undetectable at week 4)14	207/268 (77.2)	106/134 (79.1)
cEVR (HCV-RNA undetectable at week 12)14	243/268 (90.7)	121/134 (90.3)
eRVR (HCV-RNA undetectable at weeks 4 and 12)14	201/268 (75.0)	98/134 (73.1)
EOTR (HCV-RNA undetectable at EOT)	244/268 (91.0)	131/134 (97.8)
SVR2414	226/268 (84.3)	108/134 (80.6)
Failures
Non-SVR12	40/268 (14.9)	25/134 (18.7)
On-treatment failures	21/268 (7.8)	3/134 (2.2)
Virologic breakthrough	11/268 (4.1)	NA5
Treatment futility other than virologic breakthrough	3/268 (1.1)	0
HCV-RNA detectable at EOT	7/268 (2.6)	3/134 (2.2)
Posttreatment relapse6	12/244 (4.9)	20/131 (15.3)
HCV-RNA undetectable at EOT but missing PT week 12 data	7/244 (2.9)	2/131 (1.5)

¹Patients with missing data at posttreatment week 12 were considered failures;

²Difference, 4.3%; 95%CI: -3.3% to 11.9%; noninferior at the 5% significance level (lower bound of the 95%CI was > -12%);

³Patients with missing data at posttreatment week 12 were considered responders if the next available HCV-RNA value was < LLOQ;

⁴Differences and 95%CIs were as follows: RVR, -1.5% (-9.8% to 6.8%); cEVR, 0.6 (-5.5% to 6.6%); eRVR, 2.2% (-6.8% to 11.2%); SVR24, 4.4% (-3.5% to 12.2%);

⁵Not included in TVR futility criteria per prescribing information;

⁶Assessed in patients with undetectable HCV-RNA at EOT. cEVR: Complete early virologic response; DCV: Daclatasvir; EOT: End of treatment; EOTR: End of treatment response; eRVR: Early rapid virologic response; GT: Genotype; HCV: Hepatitis C virus; LLOQ: Lower limit of quantitation; mITT: Modified intent-to-treat; NA: Not applicable; pegIFN: Peginterferon alfa-2a; PT: Posttreatment; RBV: Ribavirin; SVR12: Sustained virologic response (HCV-RNA < LLOQ) at posttreatment week 12; RVR: Rapid virologic response; SVR24: Sustained virologic response at posttreatment week 24; TVR: Telaprevir.