Brand Name : RESOF Total Tablets
Contents : Velpatasvir and Sofosbuvir
Marketed by : Dr. Reddy's Laboratories Limited
Form : Tablets
Strength : Velpatasvir 100mg and Sofosbuvir 400 mg
Packing : Pack of 28 tablets
FDA approved the single-tablet regimen of SOF/VEL (400 mg/100 mg) for the treatment of
11 following patient populations:
* Patients with chronic HCV genotype 1 to 6
* Patients with or without compensated cirrhosis
* Patients with decompensated cirrhosis with ribavirin
Treatment regimen recommendation and duration based on patient population
|Treatment regimen recommendation and duration based on patient population|
|Patient Population||Treatment Regimen||Duration|
|HCV genotype 1 to 6 with or without compensated cirrhosis||Orally,once daily with or without food of SOF 400 mg/ VEL 100 mg||12 weeks|
|Decompensated cirrhosis||SOF 400 mg /VEL 100 mg plus a ribavirin||12 weeks|
|* When administered with SOF/VEL, the recommended dosage of ribavirin is based on weight (administered with food): 1000 mg per day for patients less than 75 kg and 1200 mg for those weighing at least 75 kg, divided and administered twice daily. The starting dosage and on-treatment dosage of ribavirin can be decreased based on hemoglobin and creatinine clearance. For ribavirin dosage modifications, refer to the ribavirin prescribing information.|
SOF/VEL combination with ribavirin should not be administered in patients to whom ribavirin is 20 contraindicated.
Studies revealed no clinically significant drug–drug interactions between SOF and VEL non-HCV, healthy individuals. The use of SOF or SOF-containing regimens should be avoided with rifampin, St John’s wort or tipranavir because these agents decrease the efficacy of sofosbuvir by decreasing the circulating drug levels of sofosbuvir. Velpatasvir can have decreased absorption if the patient is on 10 concomitant antacids and acid-reducing medications. SOF and VEL are substrates of drug transporter Breast Cancer Resistance Protein (BCRP) and P-glycoprotein (P-gp); drugs that are inducers of P-gp and/or moderate to potent inducers of CYP2B6, CYP2C8 or CYP3A4 (e.g., rifampin, St. John’s wort) may decrease therapeutic efficacy of SOF and VEL. VEL is an inhibitor of the drug transporters, P-gp, BCRP, OATP1B1, OATP1B3 and OATP2B1; involvement of VEL in drug interaction with these transporters may reduce absorption. At clinically relevant concentration, VEL is not an inhibitor of hepatic transporters OATP1A2 or OCT1, renal transporters OCT2, OAT1, OAT3 or MATE1 or CYP or UGT1A1 enzymes. SOF is not an inhibitor of drug transporters P-gp, BCRP, OATP1B1, 20 OATP1B3 and OCT1. SOF is not an inhibitor or inducer of CYP or UGT1A1 enzymes
Sofosbuvir/velpatasvir is an oral fixed-dose combination of sofosbuvir and the novel NS5A replication
complex inhibitor, velpatasvir. Sofosbuvir is a nucleoside analog inhibitor of hepatitis C virus NS5B
polymerase. It is a prodrug which is rapidly converted after oral intake to GS-331007 which is taken
9 up by hepatocytes. It targets RNA polymerase, thereby preventing the binding and incorporation of
nucleoside triphosphates into mRNA. Velpatasvir inhibits hepatitis C viral replication by acting on the
10 crucial membranous web that facilitates RNA replication.
Pharmacodynamics: SOF does not prolong QTc to any clinically relevant extent with recommended dosage of 400 mg as well as 1200 mg TID. In addition, VEL also does not prolong QTc interval to any 20 clinically relevant extent with recommended dosage of 500 mg. The pharmacokinetic properties of SOF/VEL are provided in Table 3.
Drug Class: Polymerase inhibitors
Chemical Structure and Molecular Formula:
Sofosbuvir/Velpatasvir Combination Therapy for Treatment-experienced Patients with 25 Genotype 1 or 3 Hepatitis C Virus Infection
Objective: To assess the efficacy and safety of SOF/VEL with and without ribavirin in treatment-experienced patients. Safety: The most common adverse events were headache, fatigue and nausea.
Conclusion: Treatment of SOF/VEL was highly effective and well tolerated in treatment-experienced patients with HCV genotype 1 or 3 infection.
Sofosbuvir/Velpatasvir combination in Patients with Genotype 1 to 6 Hepatitis C Virus Infection
Objective: To assess the safety and efficacy of SOF with VEL in patients infected with HCV genotypes
RESOF Total medication is a combination of Sofosbuvir and Velpatasvir. This drug work by reducing the amount of Hepatitis C virus in your body, which helps your immune system fight the infection and may help your liver recover..…
* Tired Feeling (Fatigue)
* Sleep problems (insomnia)