Velpaclear is an anti-hepatitis C viral medicine, containing active components known as Sofosbuvir and Velpatasvir available in the strength of 400mg & 100mg respectively. Velpatasvir is a class of anti-hepatitis C viral drug, called NS5A multiplication complex inhibitors. This may have combined with other anti-viral agent Sofosbuvir which expels its work by stopping the virus which may causes hepatitis C viral infection from spreading inside the body. Velpaclear tablet is not a curable; it is only used to control the spreading of disease.
Sofosbuvir & Velpatasvir
400mg & 100mg
Velpaclear indication and usage
Velpaclear tablets are used only in adult’s patients with long lasting hepatitis C virus caused by genotypes I, II, III, IV, V or VI
In two conditions Velpaclear tablets are used;
Without cirrhosis or with compensated cirrhosis (child Pugh A or B) With decompensated cirrhosis by combining with ribavirin (child Pugh C)
Velpaclear mechanism of action
Both the components in Velpaclear tablets are involved in inhibiting nonstructural protein which is essential for viral multiplication.
Sofosbuvir is a NS5B inhibitor, whereas Velpatasvir is considered as NS5Ainhibitor
Velpaclear is a directly acting anti-hepatitis C viral agent.
Sofosbuvir leads to produce pharmacologically active uridine analog triphosphate by intracellular metabolism. Sofosbuvir is inserted into viral HCV DNA by NS5B polymerase and act as a chain terminator. Velpatasvir inhibits NS5A protein which is responsible for viral assembly.
The peak plasma concentration time of Sofosbuvir and Velpatasvir is 0.5 to 1 hour and 3 hours respectively.
The effect of food with Velpaclear tablet determines as;
With moderate meal: Sofosbuvir increases to 60%; increases to 34%
With high fat meal: Sofosbuvir increases to 78%; increases to 21%
The blood plasma ratio of Sofosbuvir & Velpatasvir is 0.7 & 0.52 to 0.67 respectively
The human plasma protein bound; Sofosbuvir & Velpatasvir is 61 to 65% &>99.5% respectively. The metabolism of Sovihep occurs; Sofosbuvir: cathepsin A, or carboxyl esterase Velpatasvir: CYP2B6, CYP2C8 or CYP3A4
The elimination of Velpaclear occurs via; Sofosbuvir: Glomerular filtration, active tubular secretion Velpatasvir: biliary excretion The terminal half-life of Velpaclear tablets; Sofosbuvir: 0.5 hours; GS331007: 25 hours & Velpatasvir 15 hours Elimination of Sofosbuvir in urine at 80%; feces at 14% Elimination of Velpatasvir in urine 0.4%; feces at 94%
Before initiation of therapy
Before starting the therapy, patient should be examined by counting hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) for confirmation of HBV infection. The usual recommended dosage of Velpaclear tablet is one tablet should be administered as a single dose, by taking with or without food.
In new patients or experienced patients with or without cirrhosis
The prescribed dosage of Velpaclear in this condition is one tablet should be taken as a single dose.
In new or already treated patients with decompensated cirrhosis
The prescribed dosage of Velpaclear in this condition is one tablet to be taken as a single dose by combining with ribavirin.
The dosage of ribavirin
Based on body weight of the patients, the dosage of ribavirin should be recommended. Less than 75kg: 1000mg of ribavirin should be recommended At least 75kg: 1200mg of ribavirin should be recommended Ribavirin must be administered with food. Dosage adjustment should not be recommended in renal and hepatic impairment patients.
The over dosage of Velpaclear tablets; If it occurs manage with supportive measures, and hemodialysis should be recommended for eliminating the components of Velpaclear and its metabolite. Sofosbuvir is removed with the coefficient of 53%; Velpatasvir is highly bounds to human plasma protein and it is difficult to eliminate.
Velpaclear causes undesirable effects
Headache, Fatigue, Nausea, Asthenia, Insomnia, Anemia, HBV reactivation, Elevation of lipase & amylase levels, Elevation of creatine kinase, Cardiac disorder like bradycardia while concomitant with amiodarone, Angioedema, Skin rashes
Exposure of hepatitis B viral infection occurs in HBV/HCV co infections
Serious symptomatic bradycardia while concomitant with amiodarone
Risk of depletion of therapeutic effect occurs due to combination of Velpaclear with P-gp inducers or CYP3A4 inducers.
Fetal adverse occurs while concomitant with ribavirin For all these conditions, withhold or discontinue the therapy with Velpaclear tablets.