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Sofosbuvir/Velpatasvir/Voxilaprevir,SOF/VEL/VOX)

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.
Contraindications:
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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