Recommended DAA Regimens for Adults

HCV Guideline Committee, updated August 2020

All regimens listed in this guideline were available as of August 2020.

These recommendations on treatment of chronic HCV in adults aged 18 and older were developed by the NYSDOH AI HCV Guideline Committee to guide primary care providers and other clinicians in NYS in treating patients with chronic HCV infection. Treatment guidelines for patients aged 17 years and younger are available at the American Association of the Study of Liver Diseases/Infectious Disease Society of America (AASLD/IDSA) HCV Guidance.

HIV/HCV coinfection: Recommendations for treatment of chronic HCV infection in patients with HIV are the same as those for patients who do not have HIV, but attention to potential drug-drug interactions between direct-acting antivirals (DAAs) and antiretrovirals is needed (see the Drug-Drug Interactions > Drug-Drug Interactions Between DAAs and ARVs section of this guideline). Clinicians are encouraged to consult a specialist in treatment of liver disease or viral hepatitis and an experienced HIV care provider as needed.

KEY POINTS: CHOOSING AN ANTI-HCV TREATMENT REGIMEN
  • Treatment regimen recommendations are organized according to HCV genotype and subtype, the presence or absence of compensated cirrhosis, and HCV treatment history.
  • The recommended regimens within each list are in alphabetical order, not in order of preference.
  • No single regimen is recommended over another within each list of options; data on direct comparisons of treatment regimens have not been published.
  • The choice of regimen should be based on individual pretreatment assessment findings, the general considerations detailed above, and insurance coverage.
  • The regimens recommended for retreatment are for patients who have been treated previously with DAAs or pegylated interferon (PEG-IFN) plus ribavirin (RBV).

Undetectable or indeterminate genotype: Rarely, laboratories report the results of an HCV genotype test as “undetectable” or “indeterminate” for a patient with detectable HCV viral load [Germer et al., 2011]. These HCV genotype reports are consistent with active HCV infection. The laboratory may be able to clarify the specific reason for the result; for example, an “undetectable” result may be due to the lower sensitivity of the genotype test compared with the HCV RNA test or a level of HCV RNA that is too low to perform the assay for genotype.

Data on treating patients with HCV who have an undetectable or indeterminate genotype are limited. All patients should be assessed for the degree of fibrosis. In terms of HCV treatment, one option is to repeat the genotype and HCV viral load tests in 3 months and then make a determination regarding the initiation of therapy. A second option is to offer these patients DAA therapy with a pangenotypic regimen such as glecaprevir/pibrentasvir or sofosbuvir/velpatasvir at the same dose and duration recommended for treatment-naive patients with genotype 3 HCV infection, taking into consideration the degree of fibrosis (see Tables 19 and 20 > Genotype 3 in this guideline). At present, there are not sufficient data to offer ribavirin to these patients.

Recommended oral DAAs are listed in Table 7, below. All regimens listed in drug regimen tables for all HCV genotypes refer to oral medications.

Table 7: Recommended Oral Direct-Acting Antiviral Drugs and Drug Regimens for Adults [a] With Chronic HCV (August 2020)
Drug/Combination Trade Name
Glecaprevir/pibrentasvir Mavyret [b]
Ledipasvir/sofosbuvir Multiple brands [b]
Sofosbuvir/velpatasvir Multiple brands
Sofosbuvir/velpatasvir/voxilaprevir Vosevi
  1. Aged 18 years and older.
  2. Glecaprevir/pibrentasvir (GLE/PIB; Mavyret) is indicated for individuals 12 years of age and older or weighing ≥45 kg with chronic HCV genotype 1, 2, 3, 4, 5, or 6; ledipasvir/sofosbuvir (LED/SOF; multiple brands) is indicated for individuals 3 years of age and older with chronic HCV genotype 1, 4, 5, or 6. See prescribing information for full indications and information.
Reference

Germer J, Mandrekar J, Bendel J, et al. Hepatitis C virus genotypes in clinical specimens tested at a national reference testing laboratory in the United States. J Clin Microbiol 2011;49:3040-3043. [PMID: 21613437]