Description of Sovihep V
Sovihep V Description:
Sovihep V is a combination medicine, contains an active ingredients like Sofosbuvir and Velpatasvir, both having anti-viral properties.
Sovihep V is active against virus which is responsible for chronic hepatitis C viral infection.
Sovihep V is a prescription medicine; it is used by the patient under the supervision of medical practitioner.
Sofosbuvir: HCV NS5B polymerase inhibitor
Velpatasvir: HCV NS5A inhibitor
Trade name: Sovihep V
Active ingredients: Sofosbuvir and Velpatasvir
Strength of the drug: 400mg and 100mg respectively
Mfg: Zydus Cadila
Package: 28 tablets in a container
Pharmacology of Sovihep V
Sovihep V Mechanism of action:
Sovihep V containing two ingredients which exhibits antiviral activity,
Sofosbuvir: a nonstructural protein 5B polymerase inhibitor, essential for viral multiplication.
Sofosbuvir is a prodrug (nucleotide analog), metabolized into active form called uridine analogue triphosphate (GS-461203)
The metabolite GS-461203 is integrated into hepatitis C virus RNA by NS5B polymerase and performed as a chain terminator.
Velpatasvir: NS5A protein is responsible for RNA replication and aggregation of HCV virions.
Velpatasvir is a NS5A inhibitor which interfere with the enzyme activity and eradicates the viral multiply
Sovihep V Pharmacokinetics:
After oral administration of Sovihep V tablet, absorption occurs very quickly.
The peak plasma concentration of the Sofosbuvir, Velpatasvir and GS-461203 (active metabolite) occurs within 1 hour, 3 hours and 3 hours respectively.
Effect of food:
The response rate of both Sofosbuvir and Velpatasvir are similar to each other while taking with or without food.
Sofosbuvir is bound to human plasma protein in the range of 61-65%
Velpatasvir is highly bound to plasma protein around >99.5%
The active metabolite GS-461203 has poor protein binding property
Sofosbuvir is largely metabolized in liver, converted to active analogue triphosphate GS-461203
Velpatasvir is eliminated greatly in unchanged form
80%, 14%, and 2.5% of the drug is eliminated through urine, faeces and exhaled air respectively.
The terminal half life of Tablet Sovihep V is 15 hours.
Indication of Sovihep V
Sovihep V Indication:
Sovihep V is primarily indicated for the patients who are suffered with chronic hepatitis C viral infection associated genotype I, II, III, IV, V or VI infection
There are two conditions like;
Without cirrhosis or with compensated cirrhosis
With decompensated cirrhosis with use of ribavirin
Dose & Dosage's of Sovihep V
Sovihep V Dosage and administration:
Sovihep V is mainly recommended for adults, safety and efficacy of the drug has not been established for children.
Chronic hepatitis C virus (HCV) infection genotypes I, II, III, IV, V or VI
One tablet to be taken as a single dose
Sovihep V should be taken with or without food
If patient without cirrhosis or compensated cirrhosis (child Pugh A) should take Sovihep V for 12 weeks
If patient with decompensated cirrhosis (child Pugh B or C) should take Sovihep V with ribavirin for 12 weeks
The dose of ribavirin recommended on the basis of weight of patient;
<75 kg: 1000mg/day twice daily
≥75 kg: 1200mg/day twice daily
The dosage of ribavirin should be decreased on the basis of hemoglobin and creatine clearance levels.
If patient missed the dose of Sovihep V tablet, should be skipped and follow the next dose schedule
Do not take double dose
Side Effects of Sovihep V
Sovihep V Side effects:
Headache, fatigue, shortness of breath, chest pain
With decompensated cirrhosis
Fatigue, anemia, decreased hemoglobulin levels, nausea, headache, insomnia
1-10% of patients attain;
Lipase increase, rash, depression, increased creatine kinase, insomnia, asthenia
With decompensated cirrhosis;
Diarrhea, hemoglobin levels get depleted, rash, increased creatine kinase
Contraindication of Sovihep V
Sovihep V Contraindication:
Sovihep V is contraindicated to the pregnant women or become pregnant and children
While taking Sovihep V with ribavirin causes some defects to the unborn babies
Drug Interaction of Sovihep V
Sovihep V Indication: Sovihep V is primarily indicated for the patients who are suffered with chronic hepatitis C viral infection associated genotype I, II, III, IV, V or VI infection There are two conditions like; Without cirrhosis or with compensated cirrhosis With decompensated cirrhosis with use of ribavirin
Precaution of Sovihep V
Sovihep V Precautions:
Care should be taking while using Sovihep V with ribavirin, amiodarone causes;
Serious effects to unborn baby
Patient with liver and kidney disorders
Usage & Safety profile of Sovihep V Pregnancy & Lactation
Pregnancy and lactation: Generally, Sovihep V is not prescribed for pregnant women and who become pregnant and children Sovihep V with ribavirin is contraindicated to pregnant women it may cause fetal death In lactation, some metabolites are excreted in human milk it also cause some ill effects
Storage of Sovihep V
Sovihep V should be stored at room temperature.
Sovihep V container should be keep away from moisture, heat, and light