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

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

This section provides guidance on monitoring patients with chronic hepatitis C virus (HCV) infection who are starting direct-acting antiviral (DAA) treatment, are on treatment, or have completed therapy and is divided into 4 parts: pretreatment and on-treatment monitoring; post-treatment follow-up for persons in whom treatment failed to clear the virus; post-treatment follow-up for those who achieve a sustained virologic response (SVR; virologic cure); and additional considerations if treatment includes ribavirin.

Pretreatment and On-Treatment Monitoring

Recommended Assessments Prior to Starting DAA Therapy

RECOMMENDED RATING

Staging of hepatic fibrosis is essential prior to HCV treatment (see Testing and Linkage to Care and see When and in Whom to Treat).
 

Assessment of potential drug-drug interactions with concomitant medications is recommended prior to starting DAA therapy and, when possible, an interacting co-medication should be stopped or switched to an alternative with less risk for potential interaction during HCV treatment. (See Table of Drug Interactions with Direct-Acting Antivirals and Selected Concomitant Medications below or use an online resource such as University of Liverpool interaction checker.
 

Patients should be educated about the proper administration of medications (eg, dose, frequency of medicines, food effect, missed doses, adverse effects, etc), the crucial importance of adherence, and the need to inform the healthcare provider about any changes to their medication regimen.
 

The following laboratory tests are recommended within 6 months prior to starting DAA therapy:
  • Complete blood count (CBC)
  • International normalized ratio (INR)
  • Hepatic function panel (ie, albumin, total and direct bilirubin, alanine aminotransferase [ALT], aspartate aminotransferase [AST], and alkaline phosphatase levels)
  • Calculated glomerular filtration rate (eGFR)
The following laboratory tests are recommended anytime prior to starting DAA therapy:
  • Quantitative HCV RNA (HCV viral load)
  • If a non-pan-genotypic DAA will be prescribed, then test for HCV genotype and subtype.
I, C

The safety of ribavirin-free DAA regimens in humans has not been established during pregnancy and for nursing mothers, so counseling should be offered to women of childbearing age before beginning HCV treatment. (See ribavirin pregnancy recommendations below.)

I, C
All patients initiating DAA therapy should be assessed for active hepatitis B virus (HBV) coinfection with HBV surface antigen (HBsAg) testing, and for evidence of prior infection with HBV core antibody (anti-HBc) and HBV surface antibody (anti-HBs) testing. IIa, B
Patients found or known to be HBsAg positive should be assessed for whether their HBV DNA level meets AASLD criteria for HBV treatment and initiation of antiviral therapy for HBV. Strong, Moderatea
All patients initiating DAA therapy should be assessed for HIV coinfection. IIa, B
Testing for the presence of resistance-associated substitutions (RASs) prior to starting treatment should be performed as recommended in the Initial Treatment and the Retreatment sections. Additional information about RAS testing can be found in the HCV Resistance Primer. IIb, B
Patients scheduled to receive an HCV NS3 protease inhibitor (ie, grazoprevir, voxilaprevir, glecaprevir) should be assessed for a history of decompensated liver disease and liver disease severity using the Child-Turcotte-Pugh (CTP) score (see third-party calculator).
  • Patients with current or prior history of decompensated liver disease or with a current CTP score ≥7 should not receive treatment with regimens that contain NS3 protease inhibitors due to increased blood levels and/or lack of safety data.
I, A
a Unlike the AASLD/IDSA HCV guidance, the AASLD guidelines for treatment of chronic hepatitis B uses the GRADE approach to rate recommendations; please see that document for further information about this rating system.

 

Recommended Monitoring During Antiviral Therapy

RECOMMENDED RATING
Clinic visits or telephone contact are recommended as clinically indicated during treatment to ensure medication adherence, and to monitor for adverse events and potential drug-drug interactions (see table of Drug Interactions with Direct-Acting Antivirals and Selected Concomitant Medications below), especially with newly prescribed medications. I, B
Inform patients taking diabetes medication of the potential for symptomatic hypoglycemia. On-treatment and post-treatment monitoring for hypoglycemia is recommended. I, C
Inform patients taking warfarin of the potential for changes in their anticoagulation status. On-treatment and post-treatment INR monitoring for subtherapeutic anticoagulation is recommended. I, C

Patients receiving elbasvir/grazoprevir should be monitored with a hepatic function panel at 8 weeks and again at 12 weeks if receiving 16 weeks of treatment.

I, B

A 10-fold increase in ALT values (especially with signs or symptoms of liver inflammation or increasing conjugated bilirubin, alkaline phosphatase, or INR) at any time during treatment should prompt discontinuation of DAA therapy.
 

An increase in ALT <10-fold that is accompanied by any weakness, nausea, vomiting, jaundice, or significantly increased bilirubin, alkaline phosphatase, or INR should also prompt discontinuation of DAA therapy.
 

Asymptomatic increases in ALT <10-fold should be closely monitored with repeat testing at 2-week intervals. If levels remain persistently elevated, consideration should be given to discontinuation of DAA therapy.

I, B

Quantitative HCV viral load testing is recommended 12 or more weeks after completion of therapy to document SVR (cure).

I, B
For HBsAg-positive patients not already receiving HBV suppressive therapy because their baseline HBV DNA level does not meet treatment criteria, one of two approaches may be taken:
  • Initiate prophylactic HBV antiviral therapy for those with low or undetectable HBV DNA levels. If this course is elected, pending further data, prophylaxis should be continued until 12 weeks after completion of DAA therapy.
  • Monitor HBV DNA levels monthly during and immediately after DAA therapy. Antiviral treatment for HBV should be given in the event of a rise in HBV DNA >10-fold above baseline or to >1000 IU/mL in those with a previously undetectable or unquantifiable HBV DNA level.​
IIa, B

 

The recommended pretreatment testing assumes that a decision to treat with antiviral medications has already been made and that the testing involved in deciding to treat—including testing for HCV genotype and assessment of hepatic fibrosis—has already been completed (see When and in Whom to Initiate HCV Therapy).

Prior to starting treatment, patients should be evaluated for potential drug-drug interactions with selected antiviral medications by consulting the prescribing information and using other resources (eg, http://www.hep-druginteractions.org). The table below lists known drug-drug interactions between HCV DAAs and selected medications.
 

Table. Drug Interactions with Direct-Acting Antivirals and Selected Concomitant Medications
 

Concomitant Medications LDV/SOF EBR/GZR VEL/SOF GLE/PIB SOF/VEL/VOX
Acid-reducing agents Antacids
H2RA
PPI
  Antacids
H2RA
PPI
H2RA
PPI
Antacids
H2RA
PPI
Alpha-1 blockers Silodosin Prazosin
Silodosin
Prazosin
Silodosin
Prazosin
Silodosin
Prazosin
Silodosin
Antiarrhythmics Amiodarone
Dronedarone
Amiodarone
Dronedarone
Quinidine
Amiodarone
Dronedarone
Amiodarone
Dronedarone
Quinidine
Amiodarone
Dronedarone
Digoxin
Quinidine
Digoxin
Quinidine
Digoxin
Quinidine
Anticoagulant and antiplatelet agents Apixaban
Dabigatran
Edoxaban
Rivaroxaban
Ticagrelor
Warfarin
Apixaban
Dabigatran
Edoxaban
Rivaroxaban
Ticagrelor
Warfarin
Apixaban
Dabigatran
Edoxaban
Rivaroxaban
Ticagrelor
Warfarin
Dabigatran Dabigatran
Edoxaban
Apixaban
Edoxaban
Rivaroxaban
Ticagrelor
Warfarin
Apixaban
Rivaroxaban
Ticagrelor
Warfarin
Anticonvulsants and barbiturates Amobarbital
Carbamazepine
Eslicarbazine
Oxcarbazepine
Phenobarbital
Phenytoin
Primidone
Rufinamide
Amobarbital
Carbamazepine
Eslicarbazine
Oxcarbazepine
Phenobarbital
Phenytoin
Primidone
Amobarbital
Carbamazepine
Eslicarbazine
Oxcarbazepine
Phenobarbital
Phenytoin
Primidone
Rufinamide
Amobarbital
Carbamazepine
Eslicarbazine
Oxcarbazepine
Phenobarbital
Phenytoin
Primidone
Amobarbital
Carbamazepine
Eslicarbazine
Oxcarbazepine Phenobarbital
Phenytoin
Primidone
Rufinamide
Zonisamide Rufinamide Rufinamide
Antihypertensives Aliskiren
Amlodipine
Diltiazem
Eplerenone
Felodipine
Irbesartan
Isradipine
Eplerenone
Felodipine
Isradipine
Diltiazem Aliskiren Aliskiren
Enalapril
Irbesartan
Isradipine
Non-DHP CCB
Olmesartan
Telmisartan
Valsartan
Enalapril
Eplerenone
Irbesartan
Isradipine
Non-DHP CCB
Olmesartan
Telmisartan
Antipsychotics – first generation Pimozide Pimozide   Pimozide  
Droperidol
Thioridazine
Antipsychotics – second generation Paliperidone Aripiprazole
Quetiapine
  Aripiprazole
Clozapine
Paliperidone
Quetiapine
Paliperidone
Antiretrovirals See HIV/HCV Coinfection Section
Azole antifungals   Ketoconazole   Ketoconazole
Posaconazole
 
Benzodiazepines Midazolam Midazolam      
Bronchodilators       Theophylline  
Buprenorphine/ naloxone          
Calcineurin inhibitors   Cyclosporine  

Cyclosporine
Tacrolimus

Cyclosporine
Tacrolimus Tacrolimus
Cholesterol-lowering agents Rosuvastatin Atorvastatin
Fluvastatin
Gemfibrozil
Lovastatin
Rosuvastatin
Simvastatin
Atorvastatin
Fluvastatin
Lovastatin
Pitavastatin
Rosuvastatin
Simvastatin
Atorvastatin
Lovastatin
Simvastatin
Rosuvastatin
Pitavastatin
Atorvastatin
Fluvastatin
Lovastatin
Pitavastatin
Pravastatin
Simvastatin
Ezetimibe
Fluvastatin
Gemfibrozil
Pitavastatin
Pravastatin
Rosuvastatin
Pravastatin
Atorvastatin
Fluvastatin
Lovastatin
Simvastatin
Cisapride          
Ergot derivatives          
Ethinyl estradiol containing products          
Glucocorticoids   Dexamethasone   Dexamethasone Dexamethasone
Heart failure agents   Bosentan Bosentan Bosentan Bosentan
Ambrisentan Ambrisentan Ambrisentan
Herbals St. John’s wort St. John’s wort St. John’s wort St. John’s wort St. John’s wort
Loop diuretics          
Macrolide antimicrobials Telithromycin Telithromycin   Erythromycin
Telithromycin
Erythromycin
Telithromycin
Phosphodiesterase-5 inhibitors          
Rifamycin antimicrobials Rifabutin
Rifampicin
Rifapentine
Rifabutin
Rifampicin
Rifapentine
Rifabutin
Rifampicin
Rifapentine

Rifabutin
Rifampicin
Rifapentine

Rifabutin
Rifampin
Rifapentine
Rifaximin Rifaximin Rifaximin

H2RA=Histamine H2 Antagonist; PPI=proton pump inhibitor; DHP CCB=dihydropyridine calcium channel blocker; Non-DHP CCB=non dihydropyridine calcium channel blocker

Green indicates coadministration is safe; yellow indicates a dose change or additional monitoring is warranted; and red indicates the combination should be avoided. Specific concomitant medications or medication classes with actual or theoretical potential for interaction are listed in the box.

 

The education of patients and caregivers about potential adverse effects of DAA therapy and their management is an integral component of treatment and is important for a successful outcome in all patient populations. During DAA treatment, individuals should be followed at clinically appropriate intervals to ensure medication adherence, assess adverse events and potential drug-drug interactions, and monitor blood test results necessary for patient safety. This includes on-treatment and post-treatment monitoring for hypoglycemia or subtherapeutic INR levels among patients taking diabetes medicines or warfarin, respectively. Real-world data indicate an association between DAA therapy and related changes in hepatic function and alterations in dose-response relationships with these medications (Drazilova, 2018); (Abdel Alem, 2017); (Rindone, 2017); (Pavone, 2016); (DeCarolis, 2016); (Soriano, 2016). Inform patients on these medications about the potential for these developments; make dose adjustments as needed. The frequency and type of contact (eg, clinic visit, phone call, etc) are variable but need to be sufficient to assess patient safety and response to treatment, as outlined above.

Routine testing for HCV RNA during treatment is not recommended unless the ALT level fails to decline (when elevated) or there are concerns regarding patient adherence with DAA treatment. There are no data to support stopping treatment based on detectable HCV RNA during the first 4 weeks of treatment, or that detectable HCV RNA at this time point signifies medication nonadherence.

It is essential to test for HCV RNA 12 weeks (or longer) after treatment completion. Undetectable or unquantifiable HCV RNA 12 weeks or longer after treatment completion is defined as a sustained virologic response (SVR), which is consistent with cure of HCV infection. Virologic relapse is rare 12 weeks or longer after treatment completion (Simmons, 2016); (Sarrazin, 2017). Nevertheless, repeat quantitative HCV RNA testing can be considered at 24 or more weeks after completing treatment for patients in whom ALT increases to above the upper limit of normal.

During clinical trials with elbasvir/grazoprevir, with or without ribavirin, 1% of subjects experienced ALT elevations from normal levels to >5 times the upper limit of normal, generally at or after treatment week 8. ALT elevations were typically asymptomatic and most resolved with ongoing therapy or completion of therapy. Higher rates of late ALT elevations occurred in females, those of Asian descent, and patients aged ≥65 years. Hepatic laboratory testing should be performed prior to therapy, at treatment week 8, and as clinically indicated. For patients receiving 16 weeks of therapy, additional hepatic laboratory testing should be performed at treatment week 12 (Zepatier Package Insert, 2017).

Patients being treated with amiodarone should not receive sofosbuvir-based regimens due to risk of life-threatening arrhythmias. Because of its long half-life, it is advised that persons should be off amiodarone for at least 6 months before initiating sofosbuvir. If the decision is made to start sofosbuvir in this setting, continued vigilance for bradycardia should be exercised.

Pregnancy and Nursing Mothers

No adequate and well-controlled human studies are available to establish whether DAAs pose a risk to pregnancy outcomes or whether DAAs and their metabolites are present in breastmilk. Clinicians should discuss with female patients that DAAs should be used during pregnancy only if the potential benefit of DAA therapy justifies the potential risk of harm to the fetus. The health benefits of DAA therapy for nursing mothers should be weighed against the health benefits of breast feeding and the possible adverse effects of the DAA regimen on the breastfed child. Given the relatively short duration of treatment and the potential to use ribavirin-free regimens in most patients, the potential risk of harms and benefits of delaying pregnancy until HCV DAA therapy is completed should be considered. For additional information about HCV and pregnancy, click here.

Reactivation of HBV

Cases of HBV reactivation, occasionally fulminant, during or after DAA therapy have been reported in HBV/HCV coinfected patients who were not receiving HBV suppressive therapy (Chen, 2017); (Bersoff-Matcha, 2017); (Mücke, 2018). Therefore, all patients initiating HCV DAA therapy should be assessed for HBV coinfection with HBsAg testing, and for evidence of prior infection with anti-HBc and anti-HBs testing. HBV vaccination is recommended for all susceptible individuals. Testing for HBV DNA should be performed prior to DAA therapy in patients who are HBsAg positive. HBsAg positivity does not represent a contraindication to HCV DAA therapy. Patients meeting criteria for treatment of active HBV infection should be started on therapy at the same time (or before) HCV DAA therapy is initiated (Terrault, 2015).

Patients with a low or undetectable HBV DNA level can either receive prophylactic HBV treatment for the duration of DAA treatment until assessment for SVR12, or be monitored at regular intervals (usually not more frequently than every 4 weeks) for HBV reactivation with HBV DNA testing. If monitoring is elected, HBV treatment should be started if the HBV DNA level increases >10-fold or is >1000 IU/mL in a patient with undetectable or unquantifiable HBV DNA prior to DAA treatment. There are insufficient data to provide clear recommendations for the monitoring of HBV DNA among patients testing positive either for anti-HBc alone (isolated anti-HBc) or for anti-HBc and anti-HBs (resolved infection). However, the possibility of HBV reactivation should be considered in these patients in the event of an unexplained increase in liver enzymes during and/or after completion of DAA therapy.

Post-Treatment Follow-Up for Patients in Whom Treatment Failed

Recommended Monitoring for Patients in Whom Treatment Failed to Achieve a Sustained Virologic Response

RECOMMENDED RATING
Retreatment for chronic HCV should be considered utilizing the regimens recommended in the Retreatment section. I, C
Disease progression assessment every 6 to 12 months with a hepatic function panel, complete blood count (CBC), and international normalized ratio (INR) is recommended. I, C
Surveillance for hepatocellular carcinoma with liver ultrasound examination, with or without alpha fetoprotein (AFP), every 6 months is recommended for patients with cirrhosisa in accordance with the AASLD guidance on the diagnosis, staging, and management of hepatocellular carcinoma. Low, Conditionalb
For patients with cirrhosis, endoscopic surveillance for varices should be performed in accordance with the AASLD guidance on portal hypertension bleeding in cirrhosis. Guidanceb
a For decompensated cirrhosis, please refer to the appropriate section.
b Unlike the AASLD/IDSA HCV guidance, the AASLD guidelines for treatment of chronic hepatitis B uses the GRADE approach to rate recommendations; please see that document for further information about this rating system.

 

The Following Monitoring Is Not Recommended During or After Therapy

NOT RECOMMENDED RATING
Monitoring for HCV drug resistance-associated substitutions (RASs) during or after therapy is not recommended unless retreatment will be performed and RAS testing is recommended in advance of this therapy. See the Retreatment section for recommendations regarding RAS testing prior to retreatment. Additional information about RAS testing can be found in the HCV Resistance Primer. IIb, C

 

Patients who do not achieve SVR retain the possibility of continued liver injury, progression of hepatic fibrosis, and the potential to transmit HCV to others. Such patients should be considered for retreatment per the Retreatment of Persons in Whom Prior Therapy Has Failed section.

Given that persons in whom treatment failed remain at risk for ongoing liver injury and liver fibrosis progression (Dienstag, 2011), these patients should be monitored for signs and symptoms of cirrhosis. Patients in whom antiviral therapy failed may harbor viruses that are resistant to 1 or more of the antivirals at the time of virologic breakthrough (Lawitz, 2014a); (Schneider, 2014). There is no evidence to date, however, that the presence of RASs results in more progressive liver injury than would have occurred if the patient did not have resistant viruses. Additional information about RASs and RAS testing can be found in the HCV Resistance Primer section. If there remains uncertainty regarding the applicability of RAS testing, consultation with an expert in the treatment of HCV infection may be useful.

Post-Treatment Follow-Up for Patients Who Achieved a Sustained Virologic Response

Recommended Follow-Up for Patients Who Achieved a Sustained Virologic Response (SVR)

RECOMMENDED RATING
For noncirrhotic patients, recommended follow-up is the same as if they were never infected with HCV. I, B
Assessment for HCV recurrence is recommended only if the patient develops unexplained hepatic dysfunction, or annual assessment if the patient has ongoing risk factors for HCV infection. In such cases, a quantitative HCV RNA test, rather than an HCV antibody test, is recommended to assess for HCV recurrence. I, A
Surveillance for hepatocellular carcinoma is recommended for patients with cirrhosisa, in accordance with the AASLD guidance on the diagnosis, staging, and management of hepatocellular carcinoma. Strong, Moderateb
For cirrhotic patients, upper endoscopic surveillance is recommended in accordance with the AASLD guidance on portal hypertension bleeding in cirrhosis. Guidanceb
Assessment for other causes of liver disease is recommended for patients who develop persistently abnormal liver tests after achieving SVR. I, C
a For decompensated cirrhosis, please refer to the appropriate section.
b Unlike the AASLD/IDSA HCV guidance, the AASLD guidelines for treatment of chronic hepatitis B uses the GRADE approach to rate recommendations; please see that document for further information about this rating system.

 

Patients who have undetectable HCV RNA in the serum, as assessed by a sensitive polymerase chain reaction (PCR) assay, ≥12 weeks after treatment completion are deemed to have achieved SVR (cure). The likelihood of achieving SVR with DAA therapy among adherent, immunologically competent, treatment-naive patients with compensated liver disease generally exceeds 95%. Among patients who achieved SVR with peginterferon/ribavirin treatment, more than 99% have remained free of HCV infection when followed for 5 years after treatment completion (Manns, 2013). Thus, achieving SVR is considered a virologic cure of HCV infection. SVR typically aborts progression of liver injury with regression of liver fibrosis in most, but not all, treated patients (Morisco, 2013); (Morgan, 2010); (George, 2009); (Morgan, 2013); (Singal, 2010). Liver fibrosis and liver function test results improve in most patients who achieve SVR (Morisco, 2013); (Morgan, 2010); (George, 2009); (Morgan, 2013); (Singal, 2010). Because of lack of progression, noncirrhotic patients who achieve SVR should receive standard medical care that is recommended for patients who were never infected with HCV unless they remain at risk for non-HCV-related liver disease, such as nonalcoholic fatty liver disease or alcoholic liver disease.

Among cirrhotic patients who achieve SVR, decompensated liver disease (with the exception of HCC) rarely develops during follow-up, and overall survival is prolonged (Morisco, 2013); (Morgan, 2010); (George, 2009); (Morgan, 2013); (Singal, 2010). Bleeding from esophageal varices is rare after SVR (Morisco, 2013); (Morgan, 2010); (George, 2009); (Morgan, 2013); (Singal, 2010). Cirrhotic patients should undergo surveillance endoscopy every 2 years if known to have small varices and every 3 years in the absence of known varices in accordance with AASLD guidance on portal hypertension bleeding (Garcia-Tsao, 2017).

Importantly, cirrhotic patients remain at risk for developing hepatocellular carcinoma (HCC) and should, therefore, undergo surveillance every 6 months for HCC utilizing ultrasound (with or without AFP testing) despite the lowered risk that results after viral eradication (Marrero, 2018). Although multiple studies of cirrhotic patients who achieved SVR with peginterferon/ribavirin reported a reduction in the risk of developing HCC (Morisco, 2013); (Morgan, 2010); (George, 2009); (Morgan, 2013); (Singal, 2010) and a meta-analysis of persons achieving SVR with DAAs found that the risk of HCC did not exceed that seen in patients who experienced SVR with interferon-based treatment after adjustment for baseline risk factors for HCC (Waziry, 2017), one report found a higher than expected frequency of HCC in patients with HCV-related cirrhosis despite successful DAA treatment (Reig, 2016). However, a prospective observational study of 3045 cirrhotic patients found an adjusted hazard ratio for HCC of 0.57 (95% CI 0.40 to 0.81) following DAA-based therapy, implying a 43% reduction in HCC incidence (Carrat, 2019).

Bleeding from esophageal varices is uncommon after SVR (Morisco, 2013); (Morgan, 2010); (George, 2009); (Morgan, 2013); (Singal, 2010). Nevertheless, patients with compensated cirrhosis who achieve SVR should continue to receive endoscopic surveillance for esophageal varices, in accordance with the AASLD guidance on portal hypertension bleeding (Garcia-Tsao, 2017). Current AASLD recommendations for patients with compensated cirrhosis without known varices is surveillance endoscopy every 2 years if there is evidence of ongoing liver injury from associated conditions, such as obesity or alcohol use, and every 3 years if liver injury is quiescent, such as after alcohol abstinence. Patients with compensated cirrhosis and known varices should undergo surveillance endoscopy annually if there is evidence of ongoing liver injury from associated conditions, such as obesity or alcohol use, and every 2 years if liver injury is quiescent, such as after alcohol abstinence.

Patients in whom SVR is achieved but who have another potential cause of liver disease (eg, excessive alcohol use, metabolic syndrome with or without proven fatty liver disease, or iron overload) remain at risk for hepatic fibrosis progression. It is recommended that such patients be educated about the risk of liver disease and monitored for liver disease progression with periodic physical examination, blood tests, and potentially, tests for liver fibrosis by a liver disease specialist.

Patients who achieve SVR can have HCV recurrence due to reinfection or late relapse (Simmons, 2016); (Sarrazin, 2017). A systematic review suggests 5-year recurrence risks of 1%, 11%, and 15% in monoinfected low risk HCV, monoinfected high risk HCV (ie, people who currently or formerly injected drugs, imprisonment, or men who have sex with men [MSM]), and HIV/HCV coinfected patients, respectively (Simmons, 2016). At least annual testing for HCV reinfection among patients with ongoing risk for HCV infection (eg, injection drug use or high-risk sexual exposure) is recommended. A flare in liver enzyme levels should prompt immediate evaluation for HCV reinfection (see Management of Acute HCV Infection). Because HCV antibody remains positive in most patients following SVR, testing for HCV recurrence using an assay that detects HCV RNA (ie, a quantitative HCV RNA test) is recommended.

Monitoring for HCV During Chemotherapy and Immunosuppression

NOT RECOMMENDED RATING
Prospective monitoring for HCV recurrence among patients who achieved SVR and are receiving immunosuppressive drug therapy (eg, systemic corticosteroids, antimetabolites, chemotherapy, biologics agents, etc) is not routinely recommended. III, C

 

Acute liver injury is common among patients receiving chemotherapy or immunosuppressive agents. Testing for hepatitis viruses should be included in the laboratory assessment of the cause of liver injury in these patients. Approximately 23% of patients with active HCV infection—especially those with a hematologic malignancy—have a flare in their HCV RNA level (>10-fold) during chemotherapy. An ALT level increase is less common and clinical symptoms of hepatitis are uncommon (Torres, 2018). Among patients who have recovered from HCV infection, either spontaneously or with DAA treatment, reactivation of HCV (ie, detectable HCV RNA) during chemotherapy is distinctly uncommon and is not anticipated to occur since there is no residual reservoir for the virus. Thus, in this latter group, routine testing for HCV RNA during immunosuppressive treatment or prophylactic administration of antivirals during immunosuppressive treatment is not recommended.

Additional Considerations If Treatment Includes Ribavirin

Recommended Monitoring During Antiviral Therapy That Includes Ribavirin

RECOMMENDED RATING
More frequent assessment for drug-related adverse effects (ie, CBC for patients receiving ribavirin) is recommended as clinically indicated. I, C

Recommended Monitoring for Pregnancy-Related Issues Prior to and During Antiviral Therapy That Includes Ribavirin

RECOMMENDED RATING
Women of childbearing age should be counseled not to become pregnant while receiving a ribavirin-containing antiviral regimen, and for at least 6 months after stopping the regimen. I, C
Male partners of women of childbearing age should be cautioned to prevent pregnancy while they are receiving a ribavirin-containing antiviral regimen, and for up to 6 months after stopping the regimen. I, C
Serum pregnancy testing is recommended for women of childbearing age prior to beginning treatment with a regimen that includes ribavirin. I, C
Assessment of contraceptive use and of possible pregnancy is recommended at appropriate intervals during (and for 6 months after) ribavirin treatment for women of childbearing potential, and for female partners of men who receive ribavirin treatment. I, C

 

Ribavirin causes fetal death and fetal abnormalities in animals. Thus, it is imperative for persons of childbearing potential who receive ribavirin to use at least 2 reliable forms of effective contraception during treatment and for a period of 6 months thereafter. It is recommended that the healthcare practitioner document the discussion of the potential teratogenic effects of ribavirin in the patient’s medical record.

Last update: 
November 6, 2019

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