Antiviral therapy
|
Geno-type
|
Response guided therapy
|
Definition of "undetectable" HCV RNA result to assess SVR (IU/mL)
|
---|
| |
On-therapy decision?
|
Responder time point (weeks)
|
HCV RNA result considered "undetectable" †
|
Treatment duration (weeks)
| |
---|
PEGα/RBV
|
1-6
|
YES
|
4 or 12
|
week 4, (RVR) <50 IU/mL or week 12, (partial responder) 2 log10 drop
|
24, 48, or 72
|
< 50
|
PEGα/RBV +TVR
|
1
|
YES
|
4 and 12
|
TND, both RGT timepoints
|
24 or 48
|
< 25
|
PEGα/RBV +BOC
|
1
|
YES
|
8 and 16**
|
TND, both RGT timepoints
|
28, 36, or 48
|
< 25
|
PEGα/RBV +SIM
|
1
|
YES*
|
12
|
< 25 IU/mL
|
24 or 48
|
< 25
|
PEGα/RBV +SOF
|
1
|
N/A
|
N/A
|
N/A
|
12
|
< 25
|
SOF/RBV
|
2, 3
|
N/A
|
N/A
|
N/A
|
12 or 24
|
< 25
|
- * Fixed duration regimen, HCV RNA VL ≥25 IU/mL is a stopping rule.
- ** with a 4 week lead-in (PEGα/RBV)
- † The test used was the COBAS® TaqMan® for Use with the High Pure System (LLOQ = 25 IU/mL, overall LOD = 20 IU/mL)
- HCV: Hepatitis C virus. SVR: Sustained virologic response. PEGα: Pegylated interferon alpha. RBV: ribavirin. RVR: Rapid virological response. TVR: Telaprevir. TND: Target not detected. RGT: Response guided therapy. BOC: boceprevir. SIM: Simeprevir. SOF: Sofosbuvir.