However, if patients have no treatment alternatives, patients should have inpatient cardiac monitoring for the first 48 hours, followed by daily outpatient or self-monitoring of heart rate for at least the first 2 weeks of treatment. NS5A resistance-associated substitutions observed with administration of other NS5A inhibitors have been found to persist for longer than 1 year in most patients. It is more than 90% effective for hepatitis C genotypes one through six. For detailed description of trial design and recommended regimen and duration The ribavirin dosage was weight-based (1000 mg daily administered in two divided doses for subjects less than 75 kg and 1200 mg for those greater than or equal to 75 kg) and administered in two divided doses when used in combination with sofosbuvir in the ASTRAL-2 and ASTRAL-3 trials or in combination with sofosbuvir and velpatasvir in the ASTRAL-4 trial.
Of subjects receiving sofosbuvir and velpatasvir who experienced these adverse reactions, 79% had an adverse reaction of mild severity (Grade 1). Management: Avoid coadministration of BCRP/ABCG2 inhibitors and alpelisib due to the potential for increased alpelisib concentrations and toxicities. What constitutes a material change will be determined at our sole discretion. P-glycoprotein/ABCB1 Inducers: May decrease the serum concentration of Sofosbuvir.PHENobarbital: May decrease the serum concentration of Sofosbuvir.Primidone: May decrease the serum concentration of Sofosbuvir.Proton Pump Inhibitors: May decrease the serum concentration of Velpatasvir.Ranolazine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Ranolazine. dose of one or both drugs: combo may incr. The median age was 62 years (range: 45 to 81); 81% were male; 82% were White; 3% were Black; and 15% were Asian; 28% had a baseline body mass index at least 30 kg/mTrial 4062 was an open-label clinical trial that evaluated 12 weeks of treatment with sofosbuvir and velpatasvir tablets (400 mg/100 mg) in 59 HCV-infected adults with ESRD requiring dialysis. Management: Use an initial ubrogepant dose of 50 mg and second dose (at least 2 hours later if needed) of 50 mg when used with a P-gp inhibitor.Venetoclax: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Venetoclax. Those organizations are responsible for the information contained within their sites. Applies to: Renal DysfunctionThe safety and efficacy of sofosbuvir as a single agent have not been established in patients with severe renal impairment (eGFR less than 30 mL/min/1.73m2) or ESRD requiring hemodialysis.
Tenofovir Disoproxil Fumarate: Velpatasvir may increase the serum concentration of Tenofovir Disoproxil Fumarate. Management of hypoglycemia in these cases required either discontinuation or dose modification of concomitant medications used for diabetes treatment.Frequent monitoring of relevant laboratory parameters (e.g., International Normalized Ratio [INR] in patients taking warfarin, blood glucose levels in diabetic patients) or drug concentrations of concomitant medications such as cytochrome P450 substrates with a narrow therapeutic index (e.g., certain immunosuppressants) is recommended to ensure safe and effective use. Management: If combined, administer the P-gp inhibitor simultaneously with, or after, the dose of afatinib. For example, altered blood glucose control resulting in serious symptomatic hypoglycemia has been reported in diabetic patients in postmarketing case reports and published epidemiological studies. Ribavirin was permanently discontinued in 17% of subjects treated with sofosbuvir and velpatasvir with ribavirin for 12 weeks, due to adverse reactions.The following adverse reactions occurred in less than 5% of subjects without cirrhosis or with compensated cirrhosis treated with sofosbuvir and velpatasvir tablets (400 mg/100 mg) for 12 weeks and are included because of a potential causal relationship.The following adverse reactions occurred in less than 10% of subjects with decompensated cirrhosis (ASTRAL-4) treated with sofosbuvir and velpatasvir with ribavirin for 12 weeks and are included because of a potential causal relationship.In the Phase 3 trial of subjects with decompensated cirrhosis (ASTRAL-4), lipase was assessed when amylase values were greater than or equal to 1.5×ULN.
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