Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DUAL · 1 trial · 4 indications
Change in raw expression in interferon stimulated genes at week 2 or 4 compared to baseline is obtained by subtracting either 2 or 4 week measurement from baseline measurement. Negative values reflect a decrease in expression and positive values reflect an increase in expression. The raw gene expression data was normalized using quantile normalization based on all the genes in the microarray.
| Arm | Type | Description |
|---|---|---|
| Hepatitis C Virus Genotype 1A with QUAD | EXPERIMENTAL | Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks. |
| Hepatitis C Virus Genotype 1B with DUAL | EXPERIMENTAL | Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks and undergo paired liver biopsies, pre-treatment and either at 2 or 4 weeks after starting therapy. |
| Name | Type | Description |
|---|---|---|
| DUAL | DRUG | Asunaprevir and Daclatsvir |
| QUAD | DRUG | Asunaprevir, daclatsvir, peginterferon and ribavirin |
-INCLUSION CRITERIA: INCLUSION CRITERIA FOR BOTH GENOTYPES 1a and 1b: 1. Adults, ages 18 and above 2. Chronic hepatitis C (HCV RNA in serum for more than 6 months) 3. HCV Genotype 1 4. HCV RNA in serum above 10,000 IU/mL 5. Non-response to previous therapy with peginterferon and ribavirin categori...