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Generic Name and Formulations:
Ledipasvir, sofosbuvir; 90mg/400mg; tabs.
Gilead Sciences, Inc.
Indications for HARVONI:
Chronic hepatitis C virus (HCV) infection in patients with: genotype 1, 4, 5, or 6 without cirrhosis or with compensated cirrhosis; genotype 1 with decompensated cirrhosis, in combination with ribavirin; or genotype 1 or 4 who are liver transplant recipients without cirrhosis or with compensated cirrhosis, in combination with ribavirin.
Test for HBV infection prior to initiation. 1 tab once daily. Genotype 1: Treatment-naïve without cirrhosis or with compensated cirrhosis (Child-Pugh A), or treatment-experienced without cirrhosis: treat for 12 weeks; treatment-naïve without cirrhosis who have pre-treatment HCV RNA <6 million IU/mL: can be considered for 8 weeks. Treatment-experienced with compensated cirrhosis: treat for 24 weeks; can be considered for 12 weeks with concomitant ribavirin (if eligible). Treatment-naïve and -experienced with decompensated cirrhosis (Child-Pugh B or C): treat for 12 weeks with ribavirin (see full labeling). Genotype 1 or 4: Treatment-naïve and -experienced liver transplant recipients without cirrhosis or with compensated cirrhosis: treat for 12 weeks with ribavirin. Genotype 4, 5, 6: Treatment-naïve and -experienced without cirrhosis or with compensated cirrhosis: treat for 12 weeks. HCV/HIV-1 co-infection: follow same dosage schedule. See full labeling.
<12yrs and <35kg: not established. Test for HBV infection prior to initiation. ≥12yrs or ≥35kg: 1 tab once daily. Genotype 1: Treatment-naïve without cirrhosis or with compensated cirrhosis (Child-Pugh A), or treatment-experienced without cirrhosis: treat for 12 weeks. Treatment-experienced with compensated cirrhosis: treat for 24 weeks. Genotype 4, 5, 6: Treatment-naïve and -experienced without cirrhosis or with compensated cirrhosis: treat for 12 weeks. HCV/HIV-1 co-infection: follow same dosage schedule. See full labeling.
When co-administered with ribavirin, its contraindication also apply to this combination regimen (eg, Pregnancy Cat.X).
Risk of HBV reactivation in patients coinfected with HCV/HBV. Test all patients for HBV infection by measuring HBsAg and anti-HBc; if positive serologic evidence, monitor for hepatitis flare or HBV reactivation during and at post-treatment follow-up; treat if clinically indicated. Increased risk of symptomatic bradycardia when concomitant amiodarone esp. patients also taking beta blockers or with cardiac comorbidities and/or advanced liver disease. Severe renal impairment (eGFR <30mL/min/1.73m2) or ESRD requiring hemodialysis. Decompensated cirrhosis. Pregnancy. Nursing mothers.
HCV NS5A inhibitor + HCV NS5B polymerase inhibitor.
Concomitant certain immunosuppressants or chemotherapeutic agents: may increase risk of HBV reactivation. Concomitant amiodarone: not recommended; if no alternatives, monitor cardiac function (see full labeling). May increase absorption of concomitant P-gp and BCRP substrates. Concomitant P-gp inducers (eg, rifampin, St. John’s wort), other sofosbuvir-containing products, anticonvulsants (eg, carbamazepine, phenytoin, phenobarbital, oxcarbazepine), rifabutin, rifapentine, elvitegravir, cobicistat, emtricitabine, tenofovir DF, tipranavir/ritonavir, simeprevir, or rosuvastatin: not recommended. Separate dosing of antacids by 4hrs. May give H2-antagonists simultaneously or 12hrs apart (comparable to max famotidine 40mg twice daily). May give PPI doses (comparable to omeprazole ≤20mg) simultaneously under fasted conditions. May potentiate digoxin, atorvastatin (myopathy); monitor. Concomitant tenofovir DF regimens without a HIV protease inhibitor/ritonavir or cobicistat; monitor. Concomitant atazanavir/ritonavir or cobicistat + emtricitabine/tenofovir DF, darunavir/ritonavir or cobicistat + emtricitabine/tenofovir DF, or lopinavir/ritonavir + emtricitabine/tenofovir DF: consider alternatives; or if coadmin necessary, monitor. Monitor INR with warfarin.
Fatigue, headache, asthenia, nausea, diarrhea, insomnia.
For ribavirin specific dosing and safety information, refer to the full prescribing information.