5.6Laboratory Tests
HCV-RNA levels should be monitored at weeks 4 and 12 and as clinically indicated. Use of a sensitive real-time RT-PCR assay for monitoring HCV-RNA levels during treatment is recommended. The assay should have a lower limit of HCV-RNA quantification equal to or less than 25 IU/mL and a limit of HCV-RNA detection of approximately 10-15 IU/mL. For the purpose of assessing response-guided therapy eligibility, an "undetectable" HCV-RNA result is required; a confirmed "detectable but below limit of quantification" HCV-RNA result should not be considered equivalent to an "undetectable" HCV-RNA result.

Hematology eva luations (including white cell differential count) are recommended at weeks 2, 4, 8 and 12 or as clinically appropriate thereafter.

Chemistry eva luations (electrolytes, serum creatinine, uric acid, hepatic enzymes, bilirubin, and TSH) are recommended as frequently as the hematology eva luations or as clinically indicated [see Adverse Reactions (6)].

Refer to the prescribing information for peginterferon alfa and ribavirin, including pregnancy testing requirements.

5.7General
INCIVEK must not be administered as monotherapy and must only be prescribed with both peginterferon alfa and ribavirin. Therefore, the prescribing information for peginterferon alfa and ribavirin must be consulted before starting treatment with INCIVEK.

There are no clinical data on re-treating patients who have failed an HCV NS3/4A protease inhibitor-based treatment, nor are there data on repeated courses of INCIVEK [see Microbiology (12.4)].

5.8Hepatic Impairment
INCIVEK is not recommended for patients with moderate or severe hepatic impairment (Child-Pugh B or C, score greater than or equal to 7) or patients with decompensated liver disease. Refer to prescribing information for peginterferon alfa and ribavirin which must be co-administered with INCIVEK [see Use in Specific Populations: Hepatic Impairment (8.6)].

6 ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the label:

Pregnancy: Use with Ribavirin and Peginterferon alfa [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1), and Patient Counseling Information (17.1)]
Serious Skin Reactions/Rash [see Warnings and Precautions (5.2 and 5.3)]
Anemia [see Warnings and Precautions (5.4)]
INCIVEK must be administered with peginterferon alfa and ribavirin. Refer to their respective prescribing information for their associated adverse reactions.

6.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety assessment is based on data from pooled adequate and well-controlled clinical trials including 1797 subjects who received INCIVEK combination treatment and 493 who received peginterferon alfa and ribavirin.

Serious adverse drug reactions occurred in 3% of subjects who