Recommendations: Start Zepatier. Generic: Elbasvir 50mg/grazoprevir100mg single –combination tablet PO daily for a duration of 12 weeks with orwithout food. Administer HBV and HAV vaccines possibly in combination asTwinrix 1 mL IM x 3 doses at 0, 1, and 6 months.
Complete testing for NS5A resistance-associated polymorphisms (at amino acid positions 28, 30, 31 or 93) as soon asavailable to ensure more effective and complete dosage regimen and duration. ContinueOmeprazole 40mg Capsule PO Daily. Melatonin 5mg tablet PO at bedtime. Amiodarone200mg tablet PO daily. Warfarin 2.5mg PO Daily. Conduct hepatic laboratorytesting at treatment week 8 and as clinically indicated as there is anincreased risk of ALT elevations. Counsel patient on the significant importanceof maintaining compliance with Zepatier and to take every day at the regularlyscheduled time with or without food.
Inform patient to not miss or skip dosesand to take Zepatier for the duration that is recommended by their healthcareprovider. Advise on maintaining good overall health, smoking cessation andavoidance of alcohol or illicit drugs. Advise patient to contact prescriberwithout delay if early warning signs of liver inflammation occur such asfatigue, weakness, loss of appetite, nausea and vomiting as well as later signssuch as jaundice and discolored feces. Counsel patient on importance ofseparating and not sharing wife’s toothbrush or razors. Follow-up withprescriber for frequent monitoring of INR values during treatment and posttreatment as fluctuations in INR may occur. Rationale: Per AASLD/IDSA HCV Guidance: Recommendationsfor Testing, Managing and Treating Hepatitis C in Treatment –Naïve Genotype 1aWithout Cirrhosis the recommendationof a daily fixed-dose combination of elbasvir (50mg)/ grazoprevir (100mg) forpatients without baseline NS5A RASs for elbasvir with a duration of 12 weeks. Accordingto the C-WORTHY trial in which the sustained virologic response rate at 12weeks (SVR12) rate was 92% among genotype 1a treatment naïve, noncirrhoticpatients who received 12 weeks of elbasvir/grazoprevir without ribavirin(Sulkowski,2015).
According to the package insert, elbasvir is a hepatitis Cvirus NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor, and isindicated for treatment of chronic HCV genotype 1 or 4 infection in adults. Goalfor patient MG is a reduction from baseline in Hepatitis C virus RNS viral loadindicating treatment efficacy and effectiveness. Based on Zepatier’s packageinsert no dosage adjustment is recommended for geriatric patients 65 years orolder nor is there a clinically significant interaction with the medicationspatient MG is currently taking.