This version of the guidance has been updated to reflect several important developments in the identification and management of chronic hepatitis C. Where applicable, all regimens have been reordered by pan-genotypic activity, level of evidence, and alphabetically. Updated references have been provided throughout the guidance where appropriate. Sections of the guidance where key updates occurred are listed below.

Initial Treatment of Adults with HCV Infection & Patients With HIV/HCV Coinfection

• Removal of HIV as a contraindication to the simplified treatment approach.
• Addition of TDF containing regimen with eGFR <60 ml/min as an exclusion in HIV coinfection to simplified treatment approach.
• Removal of 12-week glecaprevir/pibrentasvir recommendation for HIV with cirrhosis.
• Re-ordering of all regimens by pan-genotypic activity, level of evidence, and alphabetically.

Monitoring Patients Who Are Starting HCV Treatment, Are on Treatment, or Have Completed Therapy

• Data about the minimal monitoring HCV study (MINMON) included to provide evidence to support the simplified HCV treatment monitoring algorithm.

Pediatrics:

• Addition of recommendations for sofosbuvir/velpatasvir as a treatment for DAA experienced children and adults.

This version of the guidance has been updated to reflect several important developments in the identification and management of chronic hepatitis C. Sections of the guidance where key updates occurred are listed below:

Monitoring

• This section has been updated to include guidance for patients with incomplete adherence.

Patients With HIV/HCV Coinfection:

• This section was updated with drug-drug interaction information for newer antiretroviral agents and ribavirin was removed.

Initial Treatment of Adults with HCV Infection:

• Elbasvir/grazoprevir was changed from recommended regimen to alternative regimen for genotype 1a, due to ribavirin use.
• Elbasvir/grazoprevir remains a recommended regimen for genotype 1b, as it does not require ribavirin.

Renal Impairment:

• Includes updated information based on FDA approval of sofosbuvir for patients with renal disease
• Section notes that acute interstitial nephritis has been associated with DAA use.
• Section on elbasvir/grazopervir was moved towards the end of the section as it is rarely used.

HCV in Children:

• Updated information based on FDA approval for DAA therapy in patients 3 years and older.

Updated references have been provided throughout the guidance where appropriate.

This version of the guidance has been updated to reflect several important developments in the identification and management of chronic hepatitis C. Sections of the guidance where key updates occurred are listed below:

Retreatment of Persons in Whom Prior Therapy Failed:

• The entire section was simplified with removal of less relevant sections such as treatment of interferon experienced patients.
• Focus was changed from a genotype-based approach to retreatment based on prior regimen failure. This change is in line with changes in other areas of the guidance where reliance on genotyping has been minimized or removed.
• A new section for re-treatment of multiple DAA regimen failures, including failure of sofobuvir/velpatasvir/voxilaprevir or sofosbuvir pluse glecaprevir/pibrentasvir was added.
• Supporting data and references were updated throughout; including one rating strength change based on an additional prospective, randomized study of retreatment with G/P for 16 weeks.

This version of the guidance has been updated to reflect several important developments in the identification and management of chronic hepatitis C. Sections of the guidance where key updates occurred are listed below:

HCV Testing and Linkage to Care

• Recommendations for one-time, routine and opt out testing included based on recent releases from CDC and USPSTF. Supporting text updated.

Monitoring Patients Who Are Starting HCV Treatment, Are on Treatment, or Have Completed Therapy

• New recommendation added stating that ribavirin should not be used during (or for 6 months before) pregnancy. The guidance implied this recommendation previously, but this version of the Monitoring section states it explicitly.

Initial Treatment of Adults with HCV Infection

• Introduction has been reorganized placing emphasis on the fact that although guidance is provided by genotype, most patients will fall into one of two simplified treatment algorithms.
• New real-world data on mixed infections included
• End Stage renal disease removed as a contraindication in the simplified treatment section for patients without cirrhosis.
• Real world data to support the use of glecaprevir (300mg)/pibrentasivr (120mg) for 8 weeks in cirrhotic patients added
• Daily fixed-dose combination of elbasvir (50 mg)/grazoprevir (100 mg) recommendation changed from IB to IA and supporting data included
• New integrated analysis for GT5/6 included 

Patients With HIV/HCV Coinfection

• Pharmacology and drug interaction data updated 

Patients With Decompensated Cirrhosis

• Data from TARGET long term study included
• Sentence added clearly stating that protease inhibitor-containing regimens are not recommended 

Patients Who Develop Recurrent HCV Infection Post Liver Transplantation

• Removed RBV from the box for ledipasvir/sofosbuvir in those with compensated liver disease (with or without cirrhosis). Summary of multicenter ANRS CO23 CUPILT study added to support this. 

Treatment of HCV-Uninfected Transplant Recipients Receiving Organs From HCV-Viremic Donors

• New study included regarding immediate administration of antiviral therapy after transplantation of hepatitis C‐infected solid organs (livers excluded) into uninfected recipients
• Recommendation tables updated
• New study included regarding short term duration 

Renal Impairment

• Updated final results of C-SURFER study (elbasvir/grazoprevir for renal insufficiency), VA study on elbasvir/grazoprevir in renal failure (real-world), EXPEDITION 5 (G/P for renal insufficiency), and use of sofosbuvir for renal insufficiency.
• Potential for colchicine toxicity in patients receiving G/P or LDV/SOF

HCV in Pregnancy

• Recommendation for Universal Hepatitis C Screening in Pregnancy has been updated following USPSTF and CDC updated screening recommendations

HCV in Children

• Recommendations updated to include FDA approval of (sofosbuvir/velpatasvir) for Children Ages 6 and Older or Weighing at Least 17 kg
• Regimens reordered based on age rather than level of evidence. This arrangement will make it easier for the reader to determine which regimen is for what age group. Weight-based dosing tables rearranged accordingly.

Updated references have been provided throughout the guidance where appropriate.

This version of the guidance has been updated to reflect several important developments in the identification and management of chronic hepatitis C. All treatment sections have been updated; less efficacious, complex, alternative regimens and those no longer available in the U.S. have been removed.

• Initial Treatment of HCV Infection: Shortened G/P regimen for use in compensated cirrhosis
• New Simplified HCV Treatment for Treatment-naive Patients Without Cirrhosis
• Retreatment of Persons in Whom Prior Therapy Failed: Update on SOF/VEL/VOX and G/P failures
• HCV Testing and Linkage to Care: Universal screening for adults
• HCV in Children: New treatment regimens for children aged 3 to 11 years
• Management of Acute HCV Infection: New recommendation for initiating treatment without waiting period
• Kidney Transplant Patients: Updated treatment recommendations
• Liver Transplantation: New information about transplantation of organs from HCV-infected donors
   

Updated references have been provided throughout the guidance where appropriate.

This version of the guidance has been updated to reflect new testing and management recommendations for pregnant women, people who inject drugs, men who have sex with men, and people who are incarcerated.

The following new sections for management of patients with HCV in key populations have been added to the guidance:

• Key Populations: Identification and Management of HCV in People Who Inject Drugs
• HCV in Key Populations: Men Who Have Sex With Men
• HCV Testing and Treatment in Correctional Settings
   

Updated references have been provided throughout the guidance where appropriate.

This version of the guidance has been updated to reflect several important developments, including the recent approvals of glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir. Updated recommendations reflecting these approvals are provided throughout the guidance.

In addition to updates to all the sections, the following new sections have been added to the guidance:

• HCV Resistance Primer
• Kidney Transplant Patients
• HCV in Pregnancy
• HCV in Children
   

Updated references have been provided throughout the guidance.

In addition to updates for all relevant sections in response to the new approvals, the following new sections will be released soon:

• HCV in Children
• HCV in Pregnancy
• HCV Resistance Primer

FDA announcements:

• https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm570038.htm
• https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm567467.htm

This version of the Guidance has been updated to reflect several key developments as indicated below. Updated references have been provided throughout the Guidance. 

Global Changes Occurring throughout the document:

• RAV changed to RAS
• Standardized renal function parameter from CrCI to eGFR

Initial Treatment:

• Includes new recommendation to shorten the duration of ledipasvir (90 mg)/sofosbuvir (400 mg) in patients without cirrhosis to 8 weeks for non-black, HIV-uninfected, and whose HCV RNA is <6 million IU/mL
• Updated grading of sofosbuvir/velpatasvir for genotypes 5 and 6
• Language added related to recent data regarding 8 weeks of PrOD for genotype 1b with early stage fibrosis

Retreatment:

• Updated recommendations in Genotype 3 sections

Decompensated:

• Extrapolation of data from patients with compensated cirrhosis to patients with decompensated cirrhosis in genotypes 5 and 6

Renal:

• Genotype 1 elbasvir/grazoprevir class rating changed from Class II to Class I

Upcoming Updates:

• Guidance will be forthcoming regarding treatment of adolescents living with chronic HCV given recent FDA-approvals

The HCV Guidance Panel has reviewed new information that highlights the risk of HBV infection reactivation in patients who are coinfected and who clear HCV with DAAs. They have therefore chosen to alert providers. The updated information can be found in the Monitoring Patients Who Are Starting Hepatitis C Treatment, Are On Treatment, or Have Completed Therapy section of the Guidance.

Click here to read the press release.