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Function and indication: This product is suitable for the treatment of chronic hepatitis C virus (HCV) infection in adults without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have previously received a regimen containing a direct antiviral (DAA).
Dosage and Administration:
One tablet orally once daily, taken with food, see the instructions for details.
Adverse Reactions:
Because clinical trials are conducted under a variety of different conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared with the incidence in clinical trials of another drug, and may not reflect the incidence observed in practice. Adverse Reactions in HCV-Infected Subjects Without Cirrhosis or Compensated Cirrhosis The adverse reaction data of Sofosvivo tablets are from two Phase 3 clinical trials (POLARIS-1 and POLARIS-4) that evaluated a total of 445 subjects infected with HCV genotype 1, 2, 3, 4, 5, or 6, without cirrhosis or compensated cirrhosis (Child-Pugh A) who received VOSEVI for 12 weeks. VOSEVI was studied in placebo- and active-controlled (sofosbuvir/velpatasvir) trials (see Clinical Trials). For subjects treated with sofosbuvir tablets for 12 weeks, the proportion of subjects who permanently discontinued treatment due to adverse events was 0.2%. The most common adverse reactions (adverse events assessed by the investigator as causally related and occurring in at least 10% of subjects) in subjects treated with sofosbuvir tablets for 12 weeks were headache, fatigue, diarrhea, and nausea.
This product is contraindicated in patients with hypersensitivity to the active ingredients or any of the excipients contained in this product. Concomitant use with potent P-glycoprotein (P-gp) and/or potent cytochrome P450 (CYP) inducers (e.g., rifampin, rifabutin, St. John’s wort) is contraindicated.

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