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Table 4 Comparison of therapies and key clinical decisions using hepatitis C virus RNA VL

From: Molecular diagnostics in the management of chronic hepatitis C: key considerations in the era of new antiviral therapies

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

  1. * Fixed duration regimen, HCV RNA VL ≥25 IU/mL is a stopping rule.
  2. ** with a 4 week lead-in (PEGα/RBV)
  3. † The test used was the COBAS® TaqMan® for Use with the High Pure System (LLOQ = 25 IU/mL, overall LOD = 20 IU/mL)
  4. 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.