Hepatitis C Drug Summary

Genotype 1a
Without cirrhosis: 12 weeks with Ribavirin 
With compensated cirrhosis: 24 weeks with Ribavirin 
Genotype 1b
With or without compensated cirrhosis:
12 weeks 

Adverse Reactions

• Monotherapy (without Ribavirin): Fatigue, headache
• In combination with Ribavirin: Fatigue, nausea, pruritus, insomnia
• Hepatic effects (hepatic decompensation, hepatic failure); Other effect (hypersensitivity reactions) 

• Test all patients for evidence of current or prior HBV infection before treatment initiation 
• Avoid use in patients with hypersensitivity to the components, moderate to severe hepatic impairment and concurrent use of moderate or strong inducers of CYP3A, strong inducers or inhibitors of CYP2C8 
• Use with caution in patients with severe renal impairment or ESRD requiring dialysis, post-liver transplant patients or patients with HCV/HBV coinfection
• Monitor LFTs during the first 4 weeks of treatment and when clinically indicated thereafter; monitor for signs and symptoms of hepatic decompensation

Genotype 1a and 4
Treatment-naive or PEG/RBV-experienced: 12 weeks
Treatment-naive or PEG/RBV-experienced with baseline NS5A polymorphisms: 16 weeks with Ribavirin 
Genotype 1b
Treatment-naive or PEG/RBV-experienced: 12 weeks
Treatment-naive without cirrhosis: 8 weeks
Genotype 1a or 1b
PEG/RBV/protease inhibitor-experienced: 12 weeks with Ribavirin
Genotype 3
Treatment-naive: 12 weeks with Sofosbuvir

Adverse Reactions

• GI effects (nausea/vomiting, dyspepsia); Other effects (anemia, decreased hemoglobin, insomnia, headache, dyspnea, pruritus, myalgia, fatigue, asthenia)

• Perform hepatic laboratory testing prior to therapy, at treatment week 8; additional testing at treatment week 12 in patients receiving 16 weeks therapy
• Avoid use in patients with moderate and severe hepatic impairment and taking organic anion transportation polypeptide 1B inhibitors or strong CYP3A inducers

Without prior HCV therapy with or without cirrhosis:
8 weeks
Genotype 1, 2, 4, 5, 6 treatment-experienced to PEG/RBV with or without Sofosbuvir, or Sofosbuvir with Ribavirin without cirrhosis: 8 weeks
Genotype 1, 2, 4, 5, 6 treatment-experienced to PEG/RBV with or without Sofosbuvir, or Sofosbuvir with Ribavirin with cirrhosis: 12 weeks
Genotype 3 treatment-experienced to PEG/RBV with or without Sofosbuvir, or Sofosbuvir with Ribavirin with or without cirrhosis:
16 weeks 

Adverse Reactions

• GI effects (nausea, diarrhea); Other effects (headache, fatigue, asthenia)

• Perform HBV screening before initiation of therapy due to risk of HBV reactivation in HBV/HCV coinfected patients during or after treatment
• Use with caution in patients with liver transplant history, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• Contraindicated in patients with moderate to severe hepatic impairment; concomitant use with Atazanavir-containing products, Atorvastatin, Simvastatin, Dabigatran etexilate, Ethinyl estradiol-containing products, strong P-glycoprotein (P-gp) and CYP3A inducers
• Not recommended for retreatment of patients with prior exposure to NS3/4A and/or NS5A inhibitors

Genotype 1
For treatment-naive patients without cirrhosis or with compensated cirrhosis and treatment-experienced patients without cirrhosis:
12 weks
Combination with Ribavirin for patients with Child-Pugh class B or C: 12 weeks
For treatment-experienced patients with compensated cirrhosis:
24 weeks
Genotype 4
For treatment-naive and treatment-experienced liver transplant recipients without cirrhosis or with compensated cirrhosis:
12 weeks
Combination with Ribavirin for patients with Child-Pugh class B or C: 12 weeks
May increase to 24 weeks for patients unable to tolerate Ribavirin 
Genotype 5 or 6
For treatment-naive and treatment-experienced patients without cirrhosis or with compensated cirrhosis: 12 weeks
Combination with Ribavirin for treatment-naive patients with Child-Pugh class B or C: 12 weeks
Combination with Ribavirin for treatment-experienced patients with Child-Pugh class B or C: 24 weeks 

Adverse Reactions

• GI effects (nausea, diarrhea); Other effects (fatigue, insomnia, headache)

• Avoid use in patients with hypersensitivity to components of the drug and concomitant use of potent P-gp inducers and Rosuvastatin 
• Patients taking beta-blockers or those with underlying cardiac comorbidities and/or advanced liver disease may be at increased risk for symptomatic bradycardia with co-administration of Amiodarone

• Fatigue, nausea, headache

• Use with caution in patients with severe bradycardia and heart block
• Concomitant use with moderate P-gp or CYP inducers is not recommended
• No dose adjustment required in patients with hepatic impairment or mild or moderate renal impairment

• CNS effects (headache, insomnia, asthenia); Other effects (fatigue, GI upset, back pain, HBV reactivation, symptomatic bradycardia, increased lipase, CK or bilirubin)

• Use with caution in patients with moderate-severe hepatic impairment and severe renal impairment
• Other precautions include HBV reactivation; symptomatic bradycardia when Sofosbuvir is co-administered with Amiodarone and another HCV DAA; use with potent inducers of P-gp and/or moderate to potent inducers of CYP 
• Contraindicated with concomitant Rifampicin and Rosuvastatin

12 months


3 months

9 months

• Influenza-like symptoms (fatigue, fever, headache, myalgia, arthralgia); CNS effects (depression, mood swings, irritability, somnolence); Hematologic effects (granulocytopenia, thrombocytopenia); CV effects (chest pain, edema, hypertension); Other effects (pain at injection site, dyspepsia, alopecia, thyroid function abnormalities)
• May cause or aggravate fatal or life-threatening infectious or ischemic disorders

• Contraindicated in patients with decompensated liver disease, autoimmune hepatitis
• Use with caution in patients with hepatic or renal impairment, depression or psychiatric disorders, CVD, arrhythmias, hypertension, pre-existing thyroid disease
• Maintain adequate hydration during treatment
• Withdraw drug if jaundice occurs
• Monitor LFTs

• Hemolytic anemia, fatigue, itching rash, sinusitis, gout, birth defects

• Do not give to patients with conditions that may be exacerbated by Ribavirin-induced hemolysis
• Use with caution in patients with hepatic or renal impairment
• Contraindicated in pregnancy and in patients who may become pregnant
• Low initial dose of Ribavirin (600 mg) is recommended for patients with Child-Turcotte-Pugh class C

Genotype 1 or 4:
12 months

Genotype 2 or 3: 6 months

Genotype 1 without cirrhosis: Plus Sofosbuvir x 12 weeks 
Genotype 1 with compensated cirrhosis: Plus Sofosbuvir x 24 weeks
Genotype 3 without cirrhosis:
Plus Sofosbuvir x 12-24 weeks
Genotype 3 with compensated cirrhosis:
Plus Sofosbuvir (with or without Ribavirin) x 16 weeks
Genotype 4: Plus Sofosbuvir and Peginterferon alfa x 24 weeks

Adverse Reactions

• Daclatasvir + Sofosbuvir: Fatigue, headache, nausea 

• Use with caution in patients with decompensated liver disease, pregnancy and contraception requirement, pre-, peri- or post-liver transplant, HCV/HIV, HBV coinfection, rare hereditary problems
• Dose may be increased or decreased when used concomitantly with cytochrome P450 3A/4 inducers and inhibitors
  • Avoid co-administration with strong inducers of CYP3A4

In combination with Sofosbuvir
Patient without cirrhosis:
12 weeks
Patient with cirrhosis: 
24 weeks

Adverse Reactions

• Ravidasvir + Sofosbuvir: CNS effects (headache, dizziness, insomnia, somnolence); GI effects (nausea, vomiting, diarrhea, constipation, dyspepsia, abdominal pain); Dermatologic effects (pruritus, rash, dermatitis); Other effects (fatigue, increased AST) 

• Avoid co-administration with potent Pg-p inducers (eg Carbamazepine, Phenobarbital, Phenytoin, Rifampicin, St John's wort)
• Must not to be used as monotherapy
• Use with caution in patients with renal impairment, HCV/HBV coinfection, patients with genotypes 2, 4, 5 and 6 HCV infection; patients with DM, renal impairment, severe hepatic impairment, post-liver transplant

In combination with Ribavirin
Genotype 1, 4, 5 or 6:
24 weeks
Genotype 2: 12 weeks
Genotype 3: 24 weeks
In combination with Ribavirin and Peginterferon alfa
Genotype 1, 4, 5 or 6:
12 weeks 
Genotype 3: 12 weeks

Adverse Reactions

• CNS effects (headache, insomnia, irritability); Dermatologic effects (pruritus, skin rash); GI effects (nausea, diarrhea, decreased appetite); Hematologic effects (anemia, neutropenia); Other effects (fatigue, fever, flu-like symptoms, chills, myalgia)

• Avoid use in patients with hypersensitivity to Sofosbuvir, during pregnancy and concomitant use with Amiodarone and potent P-gp inducers
• Use with caution in patients with renal impairment, HCV/HBV coinfection, treatment-experienced patients with genotype 1, 4, 5 and 6 HCV infection; patients with genotype 5 and 6 HCV infection; interferon-free regimens for patients with genotype 1, 4, 5 and 6 HCV infection; concomitant with other DAAs against HCV

• In combination with Daclatasvir, Peginterferon alfa and Ribavirin: CNS effects (headache, asthenia, insomnia); GI effects (diarrhea, nausea); Other effects (rash, dry skin, alopecia, anemia, cough, irritability, pyrexia, fatigue, pruritus, flu-like illness, myalgia)

• Must not be used as monotherapy
• Monitor liver enzymes and bilirubin levels at least once every 2 weeks for the initial 12 weeks of treatment, and every 4 weeks thereafter until completion of therapy; more frequent monitoring for any upward trend in ALT or AST levels
• Avoid in patients with moderate or severe hepatic impairment and with decompensated liver disease
• Avoid co-administration with Thioridazine, moderate or strong CYP3A inducers or inhibitors, strong OATP 1B1 inhibitors

• GI effects (nausea, taste disturbance, decreased appetite); Dermatologic effects (rashes, pruritus, dry skin); Other effects (headache, fatigue, blood dyscrasias, metabolic disturbances, palpitations, cough)

• Should be taken with meals
• Must not be used as monotherapy, used in combination with Peginterferon alfa and Ribavirin
• Use with caution in patients at risk for prolongation of QT interval
• Contraindicated in patients with autoimmune hepatitis and concurrent use of drugs that are inducers of or metabolized by cytochrome P450 isoenzymes

• GI effects (nausea, constipation); Dermatologic effects (rashes, pruritus); Other effects (dyspnea, increased blood bilirubin, photosensitivity reaction)

• Should be administered with other medicinal products (eg Sofosbuvir, Peginterferon α, Ribavirin)
• Avoid use in patients with hypersensitivity to Simeprevir, moderate or severe hepatic impairment and concomitant use w/ CYP34A inducers or inhibitors 
• Use with caution in patients with hepatic decompensation and hepatic failure

• Discomfort at injection site, redness, polyarthralgia with hand edema and rash

• Use with caution in pregnant and lactating women
• Monitor liver functions regularly
• Contraindicated in patients with hypersensitivity to Thymosin alpha-1 and those immunosuppressed following transplantation