Type:Tablet
Generic Name:Sofosbuvir + Velpatasvir
Manufacturer:Julphar Bangladesh Ltd.
Price:৳0.00
Chronic Hepatitis C
May be taken with or without food
Oral Adult Chronic Hepatitis C Indicated for adults with chronic hepatitis C virus (HCV) infection genotypes 1, 2, 3, 4, 5, and 6 1 tablet (400 mg sofosbuvir/ 100 mg velpatasvir) qDay Patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Sofosbuvir/velpatasvir for 12 weeks Patients with decompensated cirrhosis (Child-Pugh B or C): Sofosbuvir/velpatasvir plus weight-based ribavirin with food for 12 weeks Hepatic impairment Mild, moderate, or severe (Child-Pugh A, B, or C): No dosage adjustment required
Safety and efficacy not established
Renal impairment Severe renal impairment (eGFR <30mL/min/1.73 m²) or ESRD: No dosage recommendation can be give owing to higher exposures (up to 20-fold) of the predominant sofosbuvir metabolite
Hypersensitivity.
Sofosbuvir: Inhibitor of HCV NS5B RNA-dependent polymerase; its inhibition, in turn, suppresses viral replication Velpatasvir: Pangenotypic HCV NS5A inhibitor; the NS5A protein is required for viral replication
Direct-acting antivirals (DDAs) may reactivate hepatitis B virus (HBV) in patients who have a current or previous HBV infection while being treated for hepatitis C virus In a few cases, HBV reactivation in patients treated with DAA medicines resulted in serious liver problems or death Patients should be screened for evidence of current or prior HBV infection before starting treatment with DAAs, and monitored for HBV flare-ups or reactivation during DAA treatment and posttreatment follow-up Serious symptomatic bradycardia may occur if sofosbuvir is coadministered with amiodarone in combination with another direct-acting antiviral (eg, daclatasvir, simeprevir) Lactation: Unknown if sofosbuvir, velpatasvir, or their metabolites are distributed in human breast milk
>10% Without cirrhosis or with compensated cirrhosis Headache (22%),Fatigue (15%) With decompensated cirrhosis Fatigue (32%),Anemia (26%),Hemoglobin <10 g/dL (23%),Nausea (15%),Headache 11%),Insomnia (11%) 1-10% Without cirrhosis or with compensated cirrhosis Nausea (9%),Asthenia (5%),Insomnia (5%),Lipase increase >3 x ULN (3%),Rash (2%),Depression (1%),Increased creatinine kinase >10 x ULN (1%) With decompensated cirrhosis Diarrhea (10%) Hemoglobin <3.5 g/dL (7%),Rash (5%),Increased creatinine kinase ≥10 x ULN (2%)
Coadministration with drugs that increase gastric pH are expected to decrease velpatasvir serum concentration
