Hepatitis C

Ribavirin is FDA approved to be used in combination with different hepatitis C drugs for the treatment of HCV infections. Ribavirin may cause birth defects. If you are pregnant or your sexual partner is pregnant or plans to become pregnant, please let your doctor know immediately and do not take this medication. Ribavirin is also contraindicated in patients with hemoglobinopathies and patients using concomitant didanosine.

Ribavirin is dosed orally twice daily. The dose of ribavirin is individualized based on weight, genotype of the infection, and tolerability. The recommended treatment duration depends on the treatment regimen.

Use of ribavirin with a nucleoside analogue (e.g., zidovudine, lamivudine, efavirenz, and nevirapine) may increase the severity of current side effects. Concomitant use of azathioprine may increase the risk of azathioprine-related myelotoxicity. Concomitant use with any of these products should be carefully monitored. Tell your doctor about all medicines you take, including prescriptions and non-prescription medications, vitamins, and herbal supplements.

Peginterferon is FDA approved to be used in combination with Sovaldi® for the treatment of HCV genotype 1, 2, 3, or 4 infection. Peginterferon may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Monitor closely and tell your doctor immediately if symptoms of the above disorders become worse. Peginterferon is also contraindicated in patients with autoimmune hepatitis and decompensated cirrhosis.

Peginterferon is administered as a subcutaneous injection once weekly. The dose of peginterferon is individualized based on body surface area and tolerability. The recommended treatment duration depends on the treatment regimen.

Use of peginterferon with drugs that are metabolized by CYP1A2 (e.g., theophylline), methadone, and nucleoside analogues (e.g., zidovudine, lamivudine, efavirenz, and nevirapine) may increase the severity of current side effects. Concomitant use with any of these products should be carefully monitored. Tell your doctor about all medicines you take, including prescriptions and non-prescription medications, vitamins, and herbal supplements.

Fatigue/asthenia, dizziness, nausea/vomiting, diarrhea, abdominal pain, risk for infections, loss of appetite, joint pain, muscle pain, fever, rigors, hair loss, pruritus, insomnia, depression and headache.

Daklinza® is FDA approved for use in patients with HCV genotype 1 or genotype 3 infection. It must be used in combination with Sovaldi ® (sofosbuvir) and in more severe cases, ribavirin as well.

In genotype 1a patients with cirrhosis, testing for the presence of virus with NS5A resistance-associated polymorphisms is recommended.

The recommended dose for Daklinza® is one tablet (60mg) taken orally once daily.

• Patients who are taking a moderate CYP3A inducer (e.g., bosentan, dexamethasone, efavirenz, etravirine, modafinil, nafcillin, rifapentine) should receive Daklinza® 90mg daily.
• Patients who are taking a strong CYP3A inhibitor (e.g., atazanavir/ritonavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, saquinavir, telithromycin, voriconazole) should receive Daklinza® 30mg daily.

Sovaldi® is also dosed at one tablet (400mg) orally once daily. When ribavirin is indicated, the use of ribavirin is weight based and dosed orally twice daily. The recommended treatment duration is 12 weeks. However, in high risk patients, such as patients post-liver transplant or with cirrhosis, Daklinza® may be used for up to 24 weeks.

Daklinza® is contraindicated in patients who are also taking a strong CYP3A inducer (e.g., phenytoin, carbamazepine, rifampin, and St. John’s wort). Dose adjustments are necessary for patients who are taking a strong CYP3A inhibitor or moderate CYP3A inducer. Tell your doctor about all medicines you take, including prescriptions and non-prescription medications, vitamins, and herbal supplements.

Headache and fatigue.

Epclusa® is a fixed-dose combination that is FDA approved for use in patients with HCV genotype 1, 2, 3, 4, 5, or 6 infection. In patients with decompensated cirrhosis, Epclusa® is recommended to be used in combination with ribavirin.

The recommended dose for Epclusa® is one tablet (400mg of sofosbuvir and 100mg of velpatasvir) orally once daily. When ribavirin is indicated, the use of ribavirin is weight based and dosed orally twice daily. The recommended treatment duration is 12 weeks.

Concomitant use of Epclusa® and amiodarone may result in serious symptomatic bradycardia (slow heart rate). Use of Epclusa® with a P-gp inducer (e.g., rifampin, St. John’s wort) or a moderate to potent CYP inducer (e.g., bosentan, dexamethasone, efavirenz, etravirine, modafinil, nafcillin, rifapentine) may result in decreased efficacy of Epclusa®. Tell your doctor about all medicines you take, including prescriptions and non-prescription medications, vitamins, and herbal supplements.

Headache and fatigue.

Harvoni® is a fixed-dose combination that is FDA approved for use in patients with HCV genotype 1, 4, 5, or 6 infection. In certain patients with decompensated cirrhosis or post-liver transplant, Harvoni® may be recommended to be used in combination with ribavirin.

The recommended dose for Harvoni® is one tablet (400mg of sofosbuvir and 90mg of ledipasvir) orally once daily. When ribavirin is indicated, the use of ribavirin is weight based and dosed orally twice daily. The recommended treatment duration is varies between 8 and 24 weeks depending on viral load, previous treatments, and cirrhosis status.

Concomitant use of Harvoni® and amiodarone may result in serious symptomatic bradycardia. Use of Harvoni® with a P-gp inducer (e.g., rifampin, St. John’s wort) may result in decreased efficacy of Harvoni®. Tell your doctor about all medicines you take, including prescriptions and non-prescription medications, vitamins, and herbal supplements.

Headache, fatigue, and asthenia.

Olysio® is FDA approved for use in patients with HCV genotype 1 in combination with Sovaldi®.

In patients with genotype 1a infection, screening for the presence of virus with the NS3 Q80K polymorphism is strongly recommended and alternative therapy should be considered if Q80K is detected.

The recommended dose for Olysio® is one capsule (150mg) taken orally once daily with food.

Sovaldi® is also dosed at one tablet (400mg) orally once daily. The recommended treatment duration is 12 weeks in patients without cirrhosis and 24 weeks in patients with cirrhosis.

When used in combination with Sovaldi®, concomitant use with amiodarone may result in serious symptomatic bradycardia. Use of Olysio® with a moderate or strong inducer (e.g., bosentan, dexamethasone, efavirenz, etravirine, modafinil, nafcillin, rifapentine) may result in decreased efficacy of Olysio®. Concomitant use with an inhibitor of CYP3A (e.g., atazanavir/ritonavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, saquinavir, telithromycin, voriconazole) may result in increased toxicity. Tell your doctor about all medicines you take, including prescriptions and non-prescription medications, vitamins, and herbal supplements.

Fatigue, headache and nausea.

Sovaldi® is FDA approved for use in patients with HCV genotype 1, 2, 3, or 4 infection. Sovaldi® is recommended to be used in combination with ribavirin and, in certain cases, peginterferon as well.

The recommended dose for Sovaldi® is one tablet (400mg) orally once daily. When used in combination with ribavirin, the use of ribavirin is weight based and dosed orally twice daily. When peginterferon is indicated, the use of peginterferon is weight based and dosed once weekly as a subcutaneous injection. The recommended treatment duration is varies between 12 and 48 weeks depending on tolerability to interferon, genotype, and comorbidities.

Concomitant use of Sovaldi® and amiodarone may result in serious symptomatic bradycardia. Use of Sovaldi® with a P-gp inducer (e.g., rifampin, St. John’s wort) may result in decreased efficacy of Sovaldi®. Tell your doctor about all medicines you take, including prescriptions and non-prescription medications, vitamins, and herbal supplements.

Fatigue and headache.

Technivie® is FDA approved for use in patients with HCV genotype 4 infection without cirrhosis in combination with ribavirin. In patients who are treatment naïve and cannot tolerate ribavirin, Technivie® may be used as monotherapy.

Technivie® is available in daily dose pack that contains two tablets each. The recommended dose for Technivie® is 1 pack (2 tablets) taken orally once daily in the morning with food. When ribavirin is indicated, the use of ribavirin is weight based and dosed orally twice daily. The recommended treatment duration is 12 weeks.

Use of Technivie® is contraindicated with concomitant use of a moderate or strong inducer of CYP3A (e.g., phenytoin, carbamazepine, rifampin, St. John’s wort, bosentan, dexamethasone, efavirenz, etravirine,modafinil, nafcillin, rifapentine). Tell your doctor about all medicines you take, including prescriptions and non-prescription medications, vitamins, and herbal supplements.

Fatigue/weakness, nausea and insomnia

Viekira XR® is FDA approved for use in patients with HCV genotype 1 infection. In patients with genotype 1a infection, it is recommended to be used in combination with ribavirin.

Viekira XR® is available in daily dose pack that contains three tablets each. The recommended dose for Viekira XR® is 1 pack (3 tablets) taken orally once daily with food. When ribavirin is indicated, the use of ribavirin is weight based and dosed orally twice daily. The recommended treatment duration is 12 weeks in patients with genotype 1b infection and in patients with genotype 1a infection without cirrhosis. Depending on response to previous treatments, treatment duration may be extended to 24 weeks in patients with genotype 1a infection who also have cirrhosis.

Use of Viekira XR® is contraindicated with concomitant use of a moderate or strong inducer of CYP3A (e.g., phenytoin, carbamazepine, rifampin, St. John’s wort, bosentan, dexamethasone, efavirenz, etravirine,modafinil, nafcillin, rifapentine) or strong inducer of CYP2C8 (e.g., rifampin), and strong inhibitor of CYP2C8 (e.g., gemfibrozil). Tell your doctor about all medicines you take, including prescriptions and non-prescription medications, vitamins, and herbal supplements.

Fatigue, nausea, itchy skin, other skin reactions, insomnia and weakness.

Zepatier® is a fixed-dose combination that is FDA approved for use in patients with HCV genotype 1 and 4 infection. In certain patients with a baseline NS5A polymorphism or are treatment experienced, Zepatier® may be recommended to be used in combination with ribavirin.

In genotype 1a patients, testing for the presence of virus with NS5A resistance-associated polymorphisms is recommended.

The recommended dose for Zepatier® is one tablet (50mg elbasvir and 100mg grazoprevir) orally once daily. When ribavirin is indicated, the use of ribavirin is weight based and dosed orally twice daily. The recommended treatment duration varies between 12 and 16 weeks depending on genotype, previous treatment status and baseline polymorphism.

Use of Zepatier® with a strong CYP3A inducer (e.g., phenytoin, carbamazepine, rifampin, and St. John’s wort), and efavirenz is contraindicated. Concomitant use of Zepatier® with a moderate CYP3A inducer (e.g., bosentan, dexamethasone, efavirenz, etravirine, modafinil, nafcillin, rifapentine) may result in decreased efficacy of Zepatier®. Concomitant use with an inhibitor of CYP3A (e.g., atazanavir/ritonavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, saquinavir, telithromycin, voriconazole) may result in increased toxicity. Tell your doctor about all medicines you take, including prescriptions and non-prescription medications, vitamins, and herbal supplements.

Fatigue, headache, and nausea.