What is Sofosvel?
Sofosvel is the global first generic oral tablet for pan-genotypic Chronic Hepatitis C treatment. This combination (Sofosbuvir 400 mg + Valpatasvir 100 mg) drug has been approved by US FDA & European Commission for treatment of patients with all genotypic Chronic Hepatitis C virus infection. Sofosvel is used without cirrhosis or with compensated cirrhosis, and patients with advanced cirrhosis (Decompensated).
Mechanism of Action
Sofosbuvir is an inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is required for viral replication. Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator.
In a biochemical assay, GS-461203 inhibited the polymerase activity of the recombinant NS5B from HCV genotype 1b, 2a, 3a and 4a with an IC50 value ranging from 0.36 to 3.3 micromolar. GS-461203 isneither an inhibitor of human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA polymerase. Velpatasvir is an inhibitor of the HCV NS5A protein, which is required for viral replication. Resistance selection in cell culture and cross-resistance studies indicates Velpatasvir targets NS5A as its mode of action.
Sofosvel Tablet: Each film coated tablet contains Sofosbuvir INN 400 mg and Velpatasvir INN 100 mg.
Sofosvel is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infections:
- With or without cirrhosis or with compensated cirrhosis
- With decompensated cirrhosis for use in combination with Ribavirin
Dose and Administration
The recommended dosage of SOFOSVEL is one tablet taken orally once daily with or without food.One tablet of SOFOSVEL contains 400 mg of sofosbuvir and 100 mg of velpatasvir. Table 1* shows the recommended treatment regimen and duration based on patient population.
|Patient Population||Treatment Regimen and Duration|
|Patients without cirrhosis and patients with compensated cirrhosis (Child-Pugh A)||Sofosbuvir/Velpatasvir 12 weeks|
|Patients with decompensated cirrhosis (Child-Pugh B or C)||Sofosbuvir/Velpatasvir+ ribavirin* 12 weeks|
*When administered with SOFOSBUVIR/VELPATASVIR , 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.
No Dosage Recommendations in Severe Renal Impairment and End Stage Renal Disease
- The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed with treatment with Sofosbuvir/Velpatasvir for 12 weeks are headache and fatigue.
- The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed with treatment with Sofosbuvir/Velpatasvir and ribavirin for 12 weeks in patients with decompensated cirrhosis are fatigue, anemia, nausea, headache, insomnia, and diarrhea.
Sofosbuvir/Velpatasvir and ribavirin combination regimen is contraindicated in patients for whom ribavirin is contraindicated. Refer to the ribavirin prescribing information for a list of contraindications for ribavirin.
Warnings and Precautions
Bradycardia with amiodarone coadministration: Serious symptomatic bradycardia may occur in patients taking amiodarone, particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Coadministration of amiodarone with Sofosbuvir/Velpatasvir is not recommended. In patients without alternative viable treatment options, cardiac monitoring is recommended.
Sofosbuvir/Velpatasvir may cause serious side effects, including:
Slow heart rate (bradycardia). Sofosbuvir/Velpatasvir treatment may result in slowing of the heart rate along with other symptoms when taken with amiodarone (Cordarone® , Nexterone, Pacerone® ), a medicine used to treat certain heart problems. In some cases bradycardia has led to death or the need for a heart pacemaker when amiodarone is taken with medicines similar to Sofosbuvir/Velpatasvir that are a combination of sofosbuvir and another antiviral medicine. Get medical help right away if you take amiodarone with Sofosbuvir/Velpatasvir and get any of the following symptoms:
- fainting or near-fainting
- shortness of breath
- dizziness or lightheadedness
- chest pains
- not feeling well
- memory problems
- extreme tiredness
- The most common side effects of the drugs include headache and tiredness.
Before taking Sofosvel
- Apart from Hepatitis C, any other abnormalities in liver
- Are you on Dialysis, or severe kidney disease
- Do you have medical emergencies
- Are you pregnant or becoming pregnant
- Share the list of medication you are having