Unique Populations

Patients With HIV/HCV Coinfection

Recommendations Related to HCV Medication Interactions With HIV Antiretroviral Medications

RECOMMENDED RATING
Antiretroviral drug switches, when needed, should be done in collaboration with the HIV practitioner. For HIV antiretroviral and HCV direct-acting antiviral combinations not addressed below, expert consultation is recommended. I, A
Daily fixed-dose combination of elbasvir (50 mg)/grazoprevir (100 mg)
Elbasvir/grazoprevir should be used with antiretroviral drugs with which it does not have clinically significant interactions: abacavir, bictegravir, dolutegravir, doravirine, emtricitabine, lamivudine, maraviroc, raltegravir, rilpivirine, and tenofovir.
IIa, B
Daily fixed-dose combination of glecaprevir (300 mg)/pibrentasvir (120 mg)a
Glecaprevir/pibrentasvir should be used with antiretroviral drugs with which it does not have clinically significant interactions: abacavir, bictegravir, dolutegravir, doravirine, emtricitabine, lamivudine, maraviroc, raltegravir, rilpivirine, and tenofovir.

Given the increase in glecaprevir exposures and limited data on the safety of elvitegravir/cobicistat with glecaprevir/pibrentasvir, monitoring for hepatic toxicity is recommended until additional safety data are available in HIV/HCV-coinfected patients.
IIa, B
Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg)
Sofosbuvir/velpatasvir can be used with most antiretrovirals but not efavirenz, etravirine, or nevirapine. Because tenofovir levels, when given as tenofovir disoproxil fumarate, may increase with sofosbuvir/velpatasvir, concomitant use mandates consideration of renal function and should be avoided in those with an eGFR <60 mL/min.

Due to limited experience with this drug combination, renal monitoring is recommended in patients taking tenofovir disoproxil fumarate and cobicistat or ritonavir with sofosbuvir/velpatasvir. Tenofovir alafenamide may be an alternative to tenofovir disoproxil fumarate during sofosbuvir/velpatasvir treatment for patients who take cobicistat or ritonavir as part of their antiretroviral therapy.
IIa, B
Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg)
Ledipasvir/sofosbuvir can be used with most antiretrovirals. Because this therapy increases tenofovir levels when given as tenofovir disoproxil fumarate, concomitant use mandates consideration of renal function and should be avoided in those with an eGFR <60 mL/min.

Absolute tenofovir levels are highest and may exceed exposures for which there are established renal safety data when tenofovir disoproxil fumarate is administered with ritonavir- or cobicistat-containing regimens. Due to lack of sufficient safety data with this drug combination, consideration should be given to changing the antiretroviral regimen. If the combination is used, renal monitoring is recommended during the dosing period. Tenofovir alafenamide may be an alternative to tenofovir disoproxil fumarate during ledipasvir/sofosbuvir treatment for patients taking cobicistat or ritonavir as part of their antiretroviral therapy.
IIa, C
For combinations expected to increase tenofovir levels, baseline and ongoing assessment for tenofovir nephrotoxicity is recommended. IIa, C
Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg)/voxilaprevir (100 mg)
Sofosbuvir/velpatasvir/voxilaprevir should be used with antiretroviral drugs with which they do not have substantial interactions: abacavir, bictegravir, dolutegravir, doravirine, emtricitabine, lamivudine, maraviroc, raltegravir, rilpivirine, and tenofovir alafenamide.

Given increases in voxilaprevir AUC with darunavir/ritonavir or elvitegravir/cobicistat coadministration and lack of clinical safety data, monitoring for hepatic toxicity is recommended until additional safety data are available in HIV/HCV-coinfected patients.

Because this therapy has the potential to increase tenofovir levels when given as tenofovir disoproxil fumarate, concomitant use mandates consideration of renal function and should be avoided in those with an eGFR <60 mL/min. In patients concomitantly receiving sofosbuvir/velpatasvir/voxilaprevir and tenofovir disoproxil fumarate, renal monitoring is recommended during the dosing period.
IIa, B
a Dosing is 3 coformulated tablets (glecaprevir [100 mg]/pibrentasvir [40 mg]) taken once daily. Please refer to the prescribing information.

 

Regimens Not Recommended for Patients with HIV/HCV Coinfection

NOT RECOMMENDED RATING
Antiretroviral treatment interruption to allow HCV therapy is not recommended. III, A
Elbasvir/grazoprevir should not be used with cobicistat, efavirenz, etravirine, nevirapine, or any HIV protease inhibitor. III, B
Glecaprevir/pibrentasvir should not be used with atazanavir, efavirenz, etravirine, nevirapine, or ritonavir-containing antiretroviral regimens.   III, B
Sofosbuvir/velpatasvir should not be used with efavirenz, etravirine, or nevirapine. III, B
Sofosbuvir/velpatasvir/voxilaprevir should not be used with efavirenz, etravirine, nevirapine, ritonavir-boosted atazanavir, or ritonavir-boosted lopinavir. III, B
Sofosbuvir-based regimens should not be used with tipranavir. III, B
Ribavirin should not be used with didanosine, stavudine, or zidovudine. III, B

Table. Drug Interactions Between Direct-Acting Antivirals and Antiretroviral Drugs—Recommended Regimens

 

   
Ledipasvir/ Sofosbuvir

(LDV/SOF)

Sofosbuvir/ Velpatasvir

(SOF/VEL)

Elbasvir/ Grazoprevir

(ELB/GRZ)

Glecaprevir/ Pibrentasvir

(GLE/PIB)

Sofosbuvir/ Velpatasvir/ Voxilaprevir

(SOF/VEL/VOX)

Protease
Inhibitors
Boosted Atazanavir
A A      
Boosted Darunavir
A A      
Boosted Lopinavir
ND, A A     ND
NNRTIs
Doravirine
  ND   ND ND
Efavirenz
      ND ND
Rilpivirine
         
Etravirine
ND ND ND ND ND
Integrase
Inhibitors
Bictegravir
  ND ND ND  
Cobicistat-boosted elvitegravir
C C     C
Dolutegravir
        ND
Raltegravir
        ND
 
Maraviroc
ND ND ND ND ND
NRTIs
Abacavir
  ND ND   ND
Emtricitabine
         
Lamivudine
  ND ND   ND
Tenofovir disoproxil fumarate
B, C B, C     C, D
Tenofovir alafenamide
D D ND   D

Green indicates coadministration is safe; yellow indicates a dose change or additional monitoring is warranted; and red indicates the combination should be avoided.

ND: No data
A: Caution only with tenofovir disoproxil fumarate
​B: Increase in tenofovir depends on which additional concomitant antiretroviral agents are administered.
C: Avoid tenofovir disoproxil fumarate in patients with an eGFR <60 mL/min; tenofovir concentrations may exceed those with established renal safety data in individuals on ritonavir- or cobicistat-containing regimens.
D: Studied as part of fixed-dose combinations with ledipasvir/sofosbuvir or sofosbuvir/velpatasvir plus TAF, emtricitabine, elvitegravir, and cobicistat.

 

Treatment Recommendations for Patients With HIV/HCV Coinfection 

RECOMMENDED RATING

HIV/HCV-coinfected persons should be treated and retreated the same as persons without HIV infection, after recognizing and managing interactions with antiretroviral medications (see Initial Treatment of HCV Infection and Retreatment of Persons in Whom Prior Therapy Has Failed).

I, B

 

Last update: 
November 6, 2019

Patients With Decompensated Cirrhosis

Recommended for All Patients With HCV Infection Who Have Decompensated Cirrhosis 

RECOMMENDED RATING
Patients with HCV infection who have decompensated cirrhosis—moderate or severe hepatic impairment, ie, Child-Turcotte-Pugh (CTP) class B or class C—should be referred to a medical practitioner with expertise in that condition, ideally in a liver transplant center. I, C

Decompensated Cirrhosis Genotype 1-6

Recommended regimens listed by evidence level and alphabetically for:

Patients With Decompensated Cirrhosisa Who Have Genotype 1-6 and Are Ribavirin Eligible

RECOMMENDED DURATION RATING
Genotype 1, 4, 5, or 6 only: Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) with low initial dose of ribavirin (600 mg, increase as tolerated to weight-based dose)  12 weeks I, Ab
Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) with weight-based ribavirinc 12 weeks I, Ad
a Includes CTP class B and class C patients who may or may not be candidates for liver transplantation, including those with hepatocellular carcinoma.
​b Only available data for genotypes 5 and 6 are in a small number of patients with compensated cirrhosis.
​c Low initial dose of ribavirin (600 mg) is recommended for patients with CTP class C cirrhosis; increase as tolerated.
​d Only available data for genotype 6 are in patients with compensated cirrhosis.

 

Recommended regimens listed by evidence level and alphabetically for:

Patients With Decompensated Cirrhosisa Who Have Genotype 1-6 and Are Ribavirin Ineligible

RECOMMENDED DURATION RATING
Genotype 1, 4, 5, or 6 only: Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) 24 weeks I, Ab
Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) 24 weeks I, Ac
a Includes CTP class B and class C patients who may or may not be candidates for liver transplantation, including those with hepatocellular carcinoma.
​b Only available data for genotypes 5 and 6 are in a small number of patients with compensated cirrhosis.
​c Only available data for genotype 6 are in patients with compensated cirrhosis.

 

Recommended regimens listed by evidence level and alphabetically for:

Patients With Decompensated Cirrhosisa and Genotype 1-6 Infection in Whom Prior Sofosbuvir- or NS5A Inhibitor-Based Treatment Failed

RECOMMENDED DURATION RATING
Prior sofosbuvir-based treatment failure, genotype 1, 4, 5, or 6 only: Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) with low initial dose of ribavirin (600 mg; increase as tolerated) 24 weeks II, Cb
Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) with weight-based ribavirinc 24 weeks II, Cd

a Includes CTP class B and class C patients who may or may not be candidates for liver transplantation, including those with hepatocellular carcinoma.
b Only available data for genotype 6 are in patients with compensated cirrhosis.
c Low initial dose of ribavirin (600 mg) is recommended for patients with CTP class C cirrhosis.
d Only available data for genotypes 5 and 6 are in a small number of patients with compensated cirrhosis.

 

Regimens not recommended for:

Patients With Decompensated Cirrhosis (Moderate or Severe Hepatic Impairment; Child-Turcotte-Pugh Class B or C)

NOT RECOMMENDED RATING
Any protease inhibitor-containing regimen (eg, glecaprevir, grazoprevir, paritaprevir, simeprevir, and voxilaprevir). III, B
Interferon-based regimens III, B

 

Last update: 
November 6, 2019

Patients Who Develop Recurrent HCV Infection Post Liver Transplantation

Post Liver Transplantation: Genotype 1-6​

Recommended regimens listed by evidence level and alphabetically for:

Treatment-Naive and -Experienced Patients With Genotype 1-6 Infection in the Allograft Without Cirrhosis

RECOMMENDED DURATION RATING
Daily fixed-dose combination of glecaprevir (300 mg)/pibrentasvir (120 mg)a 12 weeks I, B
Genotype 1, 4, 5, or 6 only: Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) 12 weeks I, B
Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) 12 weeks I, B
a Dosing is 3 coformulated tablets (glecaprevir [100 mg]/pibrentasvir [40 mg]) taken once daily. Please refer to the prescribing information.

 

Recommended regimens listed by evidence level and alphabetically for:

Treatment-Naive and -Experienced Patients With Genotype 1-6 Infection in the Allograft With Compensated Cirrhosis

RECOMMENDED DURATION RATING
Genotype 1, 4, 5, or 6 only: Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) with ribavirin starting at 600 mg and increased as tolerated to weight-based dosea 12 weeks I, A
Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg)a 12 weeks I, B
Daily fixed-dose combination of glecaprevir (300 mg)/pibrentasvir (120 mg)a,b 12 weeks I, C
a Ribavirin was only studied with ledipasvir/sofosbuvir, however, for patients with multiple negative baseline characteristics, consideration should be given to adding ribavirin. The starting dose of ribavirin should be 600 mg/d and increased or decreased as tolerated. If renal dysfunction is present, a lower starting dose is recommended. Maximum ribavirin dose is 1000 mg/d if <75 kg and 1200 mg/d if ≥75 kg body weight.
b Dosing is 3 coformulated tablets (glecaprevir [100 mg]/pibrentasvir [40 mg]) taken once daily. Please refer to the prescribing information.

 

Recommended regimens listed by evidence level and alphabetically for:

Treatment-Naive and -Experienced Patients With Genotype 1-6 Infection in the Allograft and Decompensated Cirrhosisa

RECOMMENDED DURATION RATING
Genotype 1, 4, 5, or 6 only: Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) with low initial dose of ribavirin (600 mg, increase as tolerated)b 12 to 24 weeksc I, B
Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) starting at 600 mg and increased as toleratedb 12 to 24 weeksc I, B
a Includes CTP class B and class C patients.
b The starting dose of ribavirin should be 600 mg/d and increased or decreased as tolerated. If renal dysfunction is present, a lower starting dose is recommended. Maximum ribavirin dose is 1000 mg/d if <75 kg and 1200 mg/d if ≥75 kg body weight.
c 24-week treatment duration is recommended if treatment experienced.

 

Recommended regimen for:

DAA-Experienced Patients With Genotype 1-6 Infection in the Allograft, With or Without Compensated Cirrhosisa

RECOMMENDED DURATION RATING
Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg)/voxilaprevir (100 mg)b 12 weeks I, C
a Excludes CTP class B and class C patients.
b For patients with cirrhosis plus multiple negative baseline characteristic, consideration should be given to adding ribavirin. The starting dose of ribavirin should be 600 mg/d and increased or decreased as tolerated. If renal dysfunction is present, a lower starting dose is recommended. Maximum ribavirin dose is 1000 mg/d if <75 kg and 1200 mg/d if ≥75 kg body weight.

 

Table. DAA Interactions With Calcineurin Inhibitors
 

 

Cyclosporine (CSA)

Tacrolimus (TAC)

Sofosbuvir (SOF) 4.5-fold ↑ in SOF AUC, but GS-331007 metabolite unchanged; no a priori dose adjustment No interaction observed; no a priori dose adjustment
Ledipasvir No data; no a priori dose adjustment No data; no a priori dose adjustment
Elbasvir / grazoprevir (EBR/GZR) 15-fold ↑ in GZR AUC and 2-fold ↑ in EBR AUC; combination is not recommended 43% ↑ in TAC; no a priori dose adjustment
Velpatasvir No interaction observed; no a priori dose adjustment No data; no a priori dose adjustment
Glecaprevir / pibrentasvir (GLE/PIB) 5-fold ↑ in GLE AUC with higher doses (400 mg) of CSA; not recommended in patients requiring stable CSA doses >100 mg/day 1.45-fold ↑ in TAC AUC; no a priori dose adjustment; monitor TAC levels and titrate TAC dose as needed
Sofosbuvir / velpatasvir / voxilaprevir (SOF/VEL/VOX) 9.4-fold ↑ in VOX AUC; combination is not recommended No data; no a priori dose adjustment
AUC=area under the curve

 

Last update: 
November 6, 2019

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

Recommendations When Considering Use of HCV-Viremic Donor Organs in HCV-Uninfected Recipients

RECOMMENDED RATING

Informed consent should include the following elements:

  • Risk of transmission from an HCV-viremic donor (and with a PHS-defined increased risk donor, the potential risks for other viral infections)
  • Risk of liver disease if HCV treatment is not available or treatment is unsuccessful
  • Benefits, specifically reduced waiting time and possibly lower waiting list mortality
  • Unknown long-term consequences (hepatic and extrahepatic) of HCV exposure (even if cure is attained)
  • Risk of graft failure
  • Risk of HCV transmission to partner
I, C
Transplant programs should have a programmatic strategy to:
  • Document informed consent
  • Assure access to HCV treatment and retreatment(s), as necessary
  • Ensure long-term follow-up of recipients (beyond SVR12)
I, C

Recommendations Regarding Timing of DAA Therapy

RECOMMENDED RATING
Prophylactic/preemptive treatmenta with a pangenotyic DAA regimen is recommended. II, B
ALTERNATIVE RATING
Treatment with a pangenotypic DAA regimen within the first week after transplantation, is a reasonable alternative. A genotype-specific regimen may be used if genotype information from the donor or recipient is available to guide therapy. II, B
a Prior to HCV RNA results, typically day 0 to 1 post-transplant

 

Recommended and alternativea regimens listed by evidence level and alphabetically for:

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

RECOMMENDED DURATION RATING
Daily fixed-dose combination of glecaprevir (300 mg)/pibrentasvir (120 mg)b 8 weeks I, C
Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) 12 weeks I, C
ALTERNATIVE DURATION RATING
Genotype 1 and 4 only: Daily fixed-dose combination of elbasvir (50 mg)/grazoprevir (100 mg) for patients without baseline NS5A RASsc for elbasvir 12 weeks I, C
Genotype 1, 4, 5, or 6 only: Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) 12 weeks I, C
a Other considerations in selection of the DAA regimen:
  • Presence of liver dysfunction (eg, elevated bilirubin) as protease inhibitors should be avoided
  • Specific drugs that are contraindicated or not recommended with specific DAA agents, including but not limited to:
    • High-dose antacid therapy (eg, twice daily proton pump inhibitor)
    • Amiodarone (contraindicated with sofosbuvir-inclusive regimens; see prescribing information)
    • Specific statins (eg, atorvastatin)
  • Consideration of immunosuppressive drugs and DAA interactions (see below)

b Dosing is 3 coformulated tablets (glecaprevir [100 mg]/pibrentasvir [40 mg]) taken once daily. Please refer to the prescribing information.​
c Includes genotype 1a resistance-associated substitutions at amino acid positions 28, 30, 31, or 93 known to confer antiviral resistance.

 

Last update: 
December 11, 2019

Patients with Renal Impairment

Recommendation for Patients With CKD Stagea

RECOMMENDED RATING
No dose adjustment in direct-acting antivirals is required when using recommended regimens.b I, A or IIa, Bc
a Chronic kidney disease (CKD) stages: 1 = normal (eGFR >90 mL/min); 2 = mild CKD (eGFR 60-89 mL/min); 3 = moderate CKD (eGFR 30-59 mL/min); 4 = severe CKD (eGFR 15-29 mL/min); 5 = end-stage CKD (eGFR <15 mL/min)
b A ribavirin dose reduction may be required for patients with CKD stage 3, 4, or 5; see prescribing information for details.
c The rating is I, A for patients with CKD stage 1, 2, or 3 and IIa, B for those with CKD stage 4 or 5.

 

Last update: 
December 10, 2019

Kidney Transplant Patients

Post Kidney Transplantation: Genotype 1-6

Recommended and alternative regimens listed by evidence level and alphabetically for:

Treatment-Naive and Non-DAA-Experienced Kidney Transplant Patients With Genotype 1-6 Infection, With or Without Compensated Cirrhosis

RECOMMENDED DURATION RATING
Daily fixed-dose combination of glecaprevir (300 mg)/pibrentasvir (120 mg)b 12 weeks I, Ac
IIa, Cd
Genotype 1, 4, 5, or 6 only: Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) 12 weeks I, A
Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) 12 weeks IIa, C
ALTERNATIVE DURATION RATING
Genotype 1 or 4 only: Daily fixed-dose combination of elbasvir (50 mg)/ grazoprevir (100 mg) for patients without baseline NS5A RASse for elbasvir 12 weeks I, B
a For decompensated cirrhosis, please refer to the appropriate section.
b Dosing is 3 coformulated tablets (glecaprevir [100 mg]/pibrentasvir [40 mg]) taken once daily. Please refer to the prescribing information.​
c Based on evidence for patients without cirrhosis.
d Based on evidence for patients with compensated cirrhosis.
e Includes genotype 1a resistance-associated substitutions at amino acid positions 28, 30, 31, or 93 known to confer antiviral resistance.

 

Recommended regimen for:

DAA-Experienced Kidney Transplant Patients With Genotype 1-6 Infection, With or Without Compensated Cirrhosisa

RECOMMENDED DURATION RATING

Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg)/voxilaprevir (100 mg), with or without ribavirinb

12 weeks IIa, C
a Excludes CTP class B and class C patients. For decompensated cirrhosis, please refer to the appropriate section.
b For patients with cirrhosis and multiple negative baseline characteristic, consideration should be given to adding ribavirin. If renal dysfunction is present, a lower starting dose is recommended. Maximum ribavirin dose is 1000 mg/d for patients who weigh <75 kg and 1200 mg/d for those who weigh ≥75 kg.

For additional information on treatment of DAA failures post transplant, treatment of decompensated cirrhosis following transplantation, treatment of transplant recipients from HCV-positive donors, and post-transplant drug-drug interactions, please see Patients Who Develop Recurrent HCV Infection Post Liver Transplantation.

Last update: 
December 10, 2019

Management of Acute HCV Infection

Diagnosis of Acute HCV

Recommended Testing for Diagnosing Acute HCV Infection

RECOMMENDED RATING
HCV antibody and HCV RNA testing are recommended when acute HCV infection is suspected due to exposure, clinical presentation, or elevated aminotransferase levels (see Testing Algorithm figure). I, C

 

Pharmacologic Prophylaxis

Pharmacologic Prophylaxis Not Recommended

NOT RECOMMENDED RATING
Pre-exposure or post-exposure prophylaxis with antiviral therapy is not recommended. III, C

Medical Management and Monitoring of Acute HCV Infection

Recommendations for Medical Management and Monitoring of Acute HCV Infection

RECOMMENDED RATING
After the initial diagnosis of acute HCV with viremia (defined as quantifiable RNA), HCV treatment should be initiated without awaiting spontaneous resolution. I, B
Counseling is recommended for patients with acute HCV infection to avoid hepatotoxic insults, including hepatotoxic drugs (eg, acetaminophen) and alcohol consumption, and to reduce the risk of HCV transmission to others. I, C
Referral to an addiction medicine specialist is recommended for patients with acute HCV infection related to substance use. I, B

 

Antiviral Therapy

Recommended Regimens for Patients With Acute HCV Infection

RECOMMENDED RATING
Owing to high efficacy and safety, the same regimens that are recommended for chronic HCV infection are recommended for acute infection. IIa, C

 

Last update: 
November 6, 2019

HCV in Pregnancy

Testing

Recommendation for Universal Hepatitis C Screening in Pregnancy

RECOMMENDED RATING
As part of prenatal care, all pregnant women should be tested for HCV infection, ideally at the initial visit. (See Recommendations for Initial HCV Testing and Follow-Up.) IIb, C

Whom to Treat

Recommendation Regarding HCV Treatment and Pregnancy

RECOMMENDED RATING
For women of reproductive age with known HCV infection, antiviral therapy is recommended before considering pregnancy, whenever practical and feasible, to reduce the risk of HCV transmission to future offspring. I, B

 

Monitoring During Pregnancy

Recommendations for Monitoring HCV-Infected Women During Pregnancy

RECOMMENDED RATING
HCV RNA and routine liver function tests are recommended at initiation of prenatal care for HCV-antibody–positive pregnant women to assess the risk of mother-to-child transmission (MTCT) and degree of liver disease.  I, B
All pregnant women with HCV infection should receive prenatal and intrapartum care that is appropriate for their individual obstetric risk(s) as there is no currently known intervention to reduce MTCT. I, B
In HCV-infected pregnant women with pruritus or jaundice, there should be a high index of suspicion for intrahepatic cholestasis of pregnancy (ICP) with subsequent assessment of alanine aminotransferase (ALT), aspartate aminotransferase (AST), and serum bile acids. I, B
HCV-infected women with cirrhosis should be counseled about the increased risk of adverse maternal and perinatal outcomes. Antenatal and perinatal care should be coordinated with a maternal-fetal medicine (ie, high-risk pregnancy) obstetrician. I, B

 

Postpartum Issues

Recommendations Regarding Breastfeeding and Postpartum Care for HCV-Infected Women

RECOMMENDED RATING
Breastfeeding is not contraindicated in women with HCV infection, except when the mother has cracked, damaged, or bleeding nipples, or in the context of HIV coinfection. I, B
Women with HCV infection should have their HCV RNA reevaluated after delivery to assess for spontaneous clearance. I, B

 

Last update: 
November 6, 2019

HCV in Children

Testing

Recommendations for HCV Testing of Perinatally Exposed Children and Siblings of Children With HCV Infection

RECOMMENDED RATING
All children born to HCV-infected women should be tested for HCV infection. Testing is recommended using an antibody-based test at or after 18 months of age. I, A
Testing with an HCV-RNA assay can be considered in the first year of life, but the optimal timing of such testing is unknown. IIa, C
Testing with an HCV-RNA assay can be considered as early as 2 months of age. IIa, B
Repetitive HCV RNA testing prior to 18 months of age is not recommended. III, A
Children who are anti-HCV positive after 18 months of age should be tested with an HCV-RNA assay after age 3 to confirm chronic hepatitis C infection. I, A
The siblings of children with vertically-acquired chronic HCV should be tested for HCV infection, if born from the same mother. I, C

 

Transmission and Prevention

Recommendations for Counseling Parents Regarding Transmission and Prevention in Children with HCV Infection

RECOMMENDED RATING
Parents should be informed that hepatitis C is not transmitted by casual contact and, as such, children with HCV infection do not pose a risk to other children and can participate in school, sports, and athletic activities, and engage in all other regular childhood activities without restrictions. I, B
Parents should be informed that universal precautions should be followed at school and in the home of children with HCV infection. Educate families and children about the risk and routes of HCV transmission, and the techniques for avoiding blood exposure, such as avoiding the sharing of toothbrushes, razors, and nail clippers, and the use of gloves and dilute bleach to clean up blood. I, B

 

Monitoring and Medical Management

Recommendations for Monitoring and Medical Management of Children With HCV Infection

RECOMMENDED RATING
Routine liver biochemistries at initial diagnosis and at least annually thereafter are recommended to assess for disease progression. I, C
Appropriate vaccinations are recommended for children with HCV infection who are not immune to hepatitis B virus and/or hepatitis A virus to prevent these infections. I, C
Disease severity assessment via routine laboratory testing and physical examination, as well as use of evolving noninvasive modalities (ie, elastography, imaging, or serum fibrosis markers) is recommended for all children with chronic HCV. I, B
Children with cirrhosis should undergo hepatocellular carcinoma (HCC) surveillance and endoscopic surveillance for varices per standard recommendations. I, B
Hepatotoxic drugs should be used with caution in children with chronic hepatitis C after assessment of potential risks versus benefits of treatment. Use of corticosteroids, cytotoxic chemotherapy, and/or therapeutic doses of acetaminophen are not contraindicated in children with chronic hepatitis C. II, C
Solid organ transplantation and bone marrow transplantation are not contraindicated in children with chronic hepatitis C. II, C
Anticipatory guidance about the potential risks of ethanol for progression of liver disease is recommended for adolescents with chronic HCV infection and their families. Abstinence from alcohol and interventions to facilitate cessation of alcohol consumption, when appropriate, are advised for all persons with chronic HCV infection. I, C

 

Whom and When to Treat Among Children and Adolescents With HCV Infection

Recommendations for Whom and When to Treat Among Children and Adolescents With HCV Infection

RECOMMENDED RATING
Direct-acting antiviral (DAA) treatment with an approved regimen is recommended for all children and adolescents with HCV infection aged ≥3 years as they will benefit from antiviral therapy, regardless of disease severity. I, B
The presence of extrahepatic manifestations—such as cryoglobulinemia, rashes, and glomerulonephritis—as well as advanced fibrosis should lead to early antiviral therapy to minimize future morbidity and mortality. I, C

 

HCV Antiviral Therapy for Children and Adolescents,
Without Cirrhosis or With Compensated Cirrhosis (Child-Pugh A)

Recommended regimens listed by evidence level and alphabetically for:

Treatment-Naive or Interferon-Experienced Children and Adolescents Without Cirrhosis or With Compensated Cirrhosisa

RECOMMENDED DURATION RATING
Daily fixed-dose combination of glecaprevir (300 mg)/pibrentasvir (120 mg) for treatment-naive adolescents aged ≥12 years or weighing ≥45 kg with any genotype, without cirrhosis or with compensated cirrhosisa 8 weeks I, B
Combination ledipasvir/sofosbuvir (weight-based dosing; see table 1) for treatment-naive or interferon-experienced children aged ≥3 years with genotype 1, 4, 5, or 6, without cirrhosis or with compensated cirrhosisa 12 weeks I, B
a Child-Pugh A

 

Recommended regimens listed by evidence level and alphabetically for:

DAA-Experienced Children and Adolescents, Without Cirrhosis or With Compensated Cirrhosisa

RECOMMENDED DURATION RATING
Genotype 1, 2, 4, 5, or 6: Daily fixed-dose combination of glecaprevir (300 mg)/pibrentasvir (120 mg) for adolescents aged ≥12 years or weighing ≥45 kg with prior exposure to an interferon-based regimen (± ribavirin) and/or sofosbuvir but no exposure to NS3/4A or NS5A protease inhibitors, without cirrhosis 8 weeks I, C
Genotype 1, 2, 4, 5, or 6: Daily fixed-dose combination of glecaprevir (300 mg)/pibrentasvir (120 mg) for adolescents aged ≥12 years or weighing ≥45 kg with prior exposure to an interferon-based regimen (± ribavirin) and/or sofosbuvir but no exposure to NS3/4A or NS5A protease inhibitors, with compensated cirrhosisa 12 weeks I, C
Genotype 3: Daily fixed-dose combination of glecaprevir (300 mg)/pibrentasvir (120 mg) for adolescents aged ≥12 years or weighing ≥45 kg with prior exposure to an interferon-based regimen (± ribavirin) and/or sofosbuvir but no exposure to NS3/4A or NS5A protease inhibitors, without cirrhosis or with compensated cirrhosisa 16 weeks I, C
Genotype 1: Daily fixed-dose combination of glecaprevir (300 mg/pibrentasvir (120 mg) for adolescents aged ≥12 years or weighing ≥45 kg with prior exposure to NS3/4A protease inhibitors but no NS5A inhibitor exposure, without cirrhosis or with compensated cirrhosisa 12 weeks I, C
Genotype 1: Daily fixed-dose combination of glecaprevir (300 mg)/pibrentasvir (120 mg) for adolescents aged ≥12 years or weighing ≥45 kg with prior exposure to an NS5A inhibitor but no NS3/4A protease inhibitor exposure, without cirrhosis or with compensated cirrhosisa 16 weeks I, C
Genotype 1: Combination ledipasvir/sofosbuvir (weight-based dosing; see table 1) for children and adolescents aged ≥3 years with prior exposure to an interferon (± ribavirin) plus an HCV protease inhibitor regimen, without cirrhosis 12 weeks I, C
Genotype 1: Combination ledipasvir/sofosbuvir (weight-based dosing; see table 1) for children and adolescents aged ≥3 years with prior exposure to an interferon (± ribavirin) plus an HCV protease inhibitor regimen, with compensated cirrhosisa 24 weeks I, C
Genotype 4, 5, or 6: Combination ledipasvir/sofosbuvir (weight-based dosing; see table 1) for children and adolescents aged ≥3 years with prior exposure to an interferon (± ribavirin) plus an HCV protease inhibitor regimen, without cirrhosis or with compensated cirrhosisa 12 weeks I, C
a Child-Pugh A

 

Table 1. Weight-Based Dosing of Ledipasvir/Sofosbuvir for Children Aged ≥3 Years

Body Weight

Once Daily Dose of Ledipasvir/Sofosbuvir

<17 kg 33.75 mg/150 mg
17 to <35 kg 45 mg/200 mg
≥35 kg 90 mg/400 mg per day

 

 

Table 2. Weight-Based Dosing of Sofosbuvir in Combination With Ribavirin for Children Aged ≥3 Years

Body Weight

Once Daily Dose of Sofosbuvir

<17 kg 150 mg
17 to <35 kg 200 mg
≥35 kg 400 mg

 

Table 3. Weight-Based Dosing of Ribavirin for Children Aged ≥3 Years

Body Weight

Daily Dose of Ribavirin (divided AM and PM)

<47 kg 15 mg/kg
47 to 49 kg 600 mg
50 to 65 kg 800 mg
66 to 80 kg 1000 mg
>80 kg 1200 mg

 

Last update: 
December 10, 2019

Key Populations: Identification and Management of HCV in People Who Inject Drugs

Recommendations for Screening and Treatment of HCV Infection in People Who Inject Drugs (PWID)

RECOMMENDED RATING
Annual HCV testing is recommended for PWID with no prior testing, or past negative testing and subsequent injection drug use. Depending on the level of risk, more frequent testing may be indicated. IIa, C
Substance use disorder treatment programs and needle/syringe exchange programs should offer routine, opt-out HCV-antibody testing with reflexive or immediate confirmatory HCV-RNA testing and linkage to care for those who are infected. IIa, C
PWID should be counseled about measures to reduce the risk of HCV transmission to others. I, C
PWID should be offered linkage to harm reduction services including intranasal naloxone, needle/syringe service programs, medications for opioid use disorder, and other substance use disorder treatment programs. I, B
Active or recent drug use or a concern for reinfection is not a contraindication to HCV treatment. IIa, B

 

Recommendation for Testing for Reinfection in People Who Inject Drugs (PWID) 

RECOMMENDED RATING
At least annual HCV-RNA testing is recommended for PWID with recent injection drug use after they have spontaneously cleared HCV infection or have been successfully treated. IIa, C

 

Last update: 
November 6, 2019

HCV in Key Populations: Men Who Have Sex With Men

 

Testing

Recommendations for Testing and Prevention of HCV Infection in Men Who Have Sex With Men (MSM)

RECOMMENDED RATING
Annual HCV testing is recommended for sexually active HIV-infected adolescent and adult MSM. Depending on the presence of high-risk sexual or drug use practices, more frequent testing may be warranted. IIa, C
HCV testing at HIV pre-exposure prophylaxis (PrEP) initiation and at least annually thereafter (while on PrEP) is recommended in HIV-uninfected MSM. Depending on sexual or drug use risk practices, more frequent testing may be warranted. IIa, C
All MSM should be counseled about the risk of sexual HCV transmission with high-risk sexual and drug use practices, and educated about measures to prevent HCV infection or transmission. IIa, C

 

Treatment

Recommendation on Treatment of HCV in Men Who Have Sex With Men (MSM)

RECOMMENDED RATING
Antiviral treatment for HCV-infected MSM should be coupled with ongoing counseling about the risk of HCV reinfection, and education about methods to reduce HCV reinfection risk after cure. I, B

 

Testing for HCV Reinfection

Recommendation on Prevention of HCV Reinfection in Men Who Have Sex With Men (MSM)

RECOMMENDED RATING
At least annual (and risk-based, if indicated) HCV testing with HCV RNA is recommended for sexually active MSM after successful treatment or spontaneous clearance of HCV infection. IIa, C

 

Last update: 
November 6, 2019
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