Initial Treatment of HCV Infection

Initial treatment of HCV infection includes patients with chronic hepatitis C who have not been previously treated with interferon, peginterferon, ribavirin, or any HCV direct-acting antiviral (DAA) agent, whether experimental, investigational, or US Food and Drug Administration (FDA) approved.

The level of evidence available to inform the best regimen for each patient and the strength of the recommendation vary, and are rated accordingly (see Methods Table 2). In addition, specific recommendations are given when treatment differs for a particular group (eg, those infected with different genotypes). Recommended regimens are those that are favored for most patients in a given group, based on optimal efficacy, favorable tolerability and toxicity profiles, and treatment duration. Alternative regimens are those that are effective but, relative to recommended regimens, have potential disadvantages, limitations for use in certain patient populations, or less supporting data than recommended regimens. In certain situations, an alternative regimen may be an optimal regimen for an individual patient. Not recommended regimens are clearly inferior compared to recommended or alternative regimens based on factors such as lower efficacy, unfavorable tolerability and toxicity, longer treatment duration, and/or higher pill burden. Unless otherwise indicated, such regimens should not be administered to patients with HCV infection. Specific considerations for pediatric patients and persons with HIV/HCV coinfection, decompensated cirrhosis (moderate or severe hepatic impairment; Child-Turcotte-Pugh [CTP] class B or C), HCV infection post liver transplant, and severe renal impairment, end-stage renal disease (ESRD), or post kidney transplant are addressed in other sections of the guidance.

Simplification of the treatment regimen may expand the number of healthcare professionals who prescribe antiviral therapy and increase the number of persons treated. This would align with the National Academies of Science, Engineering, and Medicine strategy to reduce cases of chronic HCV infection by 90% by 2030 (NASEM, 2017).

Recommended and alternative regimens are listed in order of level of evidence. When several regimens are at the same recommendation level, they are listed in alphabetical order. Regimen choice should be determined based on patient-specific data, including drug-drug interactions. Patients receiving antiviral therapy require careful pretreatment assessment for comorbidities that may influence treatment response. All patients require careful monitoring during treatment, particularly for anemia if ribavirin is included in the regimen (see Monitoring section).

The following pages include guidance for management of treatment-naive patients.

Mixed Genotypes

Rarely, genotyping assays may indicate the presence of a mixed infection (eg, genotypes 1a and 2). Treatment data for mixed genotypes with DAAs are sparse but utilization of a pangenotypic regimen should be considered. When the correct combination or duration of treatment is unclear, expert consultation should be sought.

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Last update: 
September 21, 2017