Trade name: Hepcvel
Composition: Sofosbuvir & Velpatasvir
Strength of the components: 400mg & 100mg respectively
Manufacturer name: Cipla
Package: 28 tablets in a container
Classification: Anti-viral drug.
Drug Prescribing Information of Hepcvel tablets:
Hepcvel tablets are used in the conditions like hepatitis C viral infection in adolescents.
HCV infection is caused by various genotypes like I, II, III, IV, V or VI.
Hepcvel is used in following conditions like;
Patients with decompensated with long-lasting condition used in combination with ribavirin.
Patients suffered from compensated cirrhosis or without cirrhosis.
Mechanism of Action of Hepcvel:
A Hepcvel tablet containing directly acting anti-viral agents such as sofosbuvir & Velpatasvir which expels their actions by undergoing some mechanism includes;
Sofosbuvir is an inhibitor of HCV NS5B RNA dependent RNA polymerase, an enzyme essential for viral production. Hence this inhibition causes depletion in viral proliferation.
Velpatasvir is an inhibitor of HCV NS5A is a pan genotype, NS5A is a protein required for HCV viral replication thus the inhibition leads to reduce the production of HCV virus in the human body.
If gastric pH level increases lead to cause the decrease in solubility of Velpatasvir.
The peak concentration time of both sofosbuvir and Velpatasvir occurs at 0.5 to 1 hour and 3 hours respectively.
The peak plasma concentration of sofosbuvir and Velpatasvir exist in 567ng/ml & 259ng/ml respectively.
The human plasma protein bound to sofosbuvir and Velpatasvir with the range of 61 to 65% and >99.5% respectively.
Sofosbuvir is metabolized hepatically, with the help of cathepsin A, CES1 & HINT1.
Sofosbuvir is a substrate of P-gp transporter and breast cancer resistance protein.
Velpatasvir is partially metabolized and it is excreted as an unchanged form.
The mean terminal half-life period of both sofosbuvir and Velpatasvir and the circulating metabolite called GS-331007 are reaching at 0.5 hours, 15 hours, & 27 hours respectively.
The main routes of excretion of all the components like;
Sofosbuvir by metabolism; Velpatasvir through bile in unchanged form & GS-331007 through glomerular filtration and active tubular secretion.
Sofosbuvir: 80%; Velpatasvir: 14%
Sofosbuvir: 0.4%; Velpatasvir: 94%
When to take the Tablet Hepcvel:
Hepcvel tablets should be administered with or without food.
To administer the Hepcvel tablets frequently at the same time every day, as a single dose.
If concomitant with ribavirin, Hepcvel must be taken with food.
Gastric pH increasing drugs causes depletion in effect of serum concentration of Velpatasvir, to avoid these complications consume the antacids, H2 antagonist and proton pump inhibitors before the dose of Hepcvel.
Dosage Regimens of Hepcvel tablets:
Before initiating the therapy, patients should be examined by counting the hepatitis B surface antigen and hepatitis B core antibody (HBsAg & Anti-HBc) to prevent the problem like reactivation of HBV infection.
The prescribed dosage of Hepcvel tablets includes as;
Hepcvel containing fixed-dose combination drugs like 400mg of sofosbuvir and 100mg of Velpatasvir.
Recommended Hepcvel tablets in patients with chronic HCV infection related to genotypes like I, II, III, IV, V or VI.
Patients with child Pugh A: one tablet of Hepcvel should be administered as a single dose.
Patients with chronic cirrhosis or decompensated: Hepcvel tablets should be combined with ribavirin.
The ribavirin dosage should be administered on the basis of the weight of the patients.
At least 75kg: 1000mg per day
>75kg: 1200mg per day
No dosage adjustment is required for renal impaired patients.
Drug Called side effects:
Some effects may occur during the therapy of Hepcvel tablets;
Elevate lipase level
Elevation of creatinine kinase
Life-threatening condition like severe symptomatic bradycardia occurs while co-administration with amiodarone.
Drug Interaction of Hepcvel:
Hepcvel tablets are P-gp & BCRP drug transporters substrate while combining Hepcvel with P-gp inducers causes depletion in plasma concentration of Hepcvel tablet leads to reduce the curative effect.
Hepcvel tablet concomitant with acid-reducing agents causes the decrease in the effect of concentration of Velpatasvir.
Hepcvel with amiodarone causes serious bradycardia.
Hepcvel tablet combined with digoxin causes increasing the serum concentration of digoxin.
Hepcvel tablet with anticonvulsants causes depletion of the effect of concentration of Hepcvel tablet.
Hepcvel tablet concurrently used with anti-mycobacterials causes depletion of the Hepcvel tablet.
Hepcvel tablet combined with HIV anti-retroviral agents leads to cause decrease the serum concentration of Velpatasvir.
Hepcvel tablet combining with HMG CoA reductase agents leads to increase the concentration of these agents.
Food -Drug Interactions:
No food-drug interaction occurs, an herbal product like st. Johns wort combining with Hepcvel causes decreasing the therapeutic effect of Hepcvel.
Hepcvel tablets while using alone it is safe if it is combined with ribavirin which is contraindicated in pregnant women.
The anaphylactic reaction occurs while patients are contraindicated to the components present in Hepcvel tablet.
While taking Hepcvel tablet some adverse effects occur, to avoid these conditions some precautions should be taken.
After completion of therapy, reactivation of HBV infection occurs in the patients who are co-infected with HCV/HBV infections, to avoid these conditions investigate the patient by measuring HBsAg and anti-HBc.
Serious bradycardia occurs while combining with amiodarone.
Reduction in the therapeutic effect of Hepcvel tablets, while the concomitant use of Hepcvel with P-gp inducers.
Ribavirin with Hepcvel tablets in chronic condition causes ill to pregnant women cause fetal harm.
Care should be taken in renal and hepatic impaired patients.
Pregnancy and Lactation:
Hepcvel used alone then its pregnancy category comes under B1; safe to use.
If Hepcvel combined with ribavirin, pregnancy category is X; causes fetal death.
Breastfeeding should not be recommended during therapy.
Storage and Handling:
Hepcvel tablets container should be stored at room temperature below 30oC.
Keep the container away from moisture, heat, and light.
Hepcvel is not a normal drug, it is prescription medicine used only by the patients who are all having a valid prescription.
If the patient fails to take the dose of Hepcvel tablet, must get advice from a physician and take the medicine within the time because it is single dose therapy.
Otherwise, the missed dose should be skipped and follow the regular dosing schedule.
No distinct antidote is applicable for overdosing of Hepcvel tablets; once the overdose occurs to confirm the presence of toxicity.
Treatment: check the crucial symptoms and give supportive measures.
Hemodialysis is one of the methods used to remove components of Hepcvel tablets.
It can appropriately be cleared the prevalent circulating metabolite of sofosbuvir, GS-331007 with eradicating ration of 53%.
Hence Velpatasvir is highly bound to the human plasma protein; it is not cleared by hemodialysis and gives incredible results.