Medicine Overview of Dualvir 90mg+400mg Tablet
Dualvir is a combination of two antiviral medicines. This prescription medicine is used in the treatment of chronic hepatitis C virus (HCV) infection. It fights against the viruses to resolve the infection.
Dualvir should be taken in the prescribed dose and duration. It can be taken with or without food, but take it at the same time daily. It is advised not to consume more than the recommended dose. It is important to inform your doctor if you have any health conditions such as liver or kidney disease. It is harmful to consume alcohol along with this medicine, so it is advised to limit or avoid alcohol. The course of the medicine should be completed for better results.
The common side effects of this medicine are tiredness and headache. You should drink plenty of fluid and eat a healthy diet to prevent or overcome the side effects. Before taking the medicine, inform your doctor if you are taking any other medicines or supplements.
- Chronic hepatitis C virus (HCV) infection
- Tiredness
- Headache
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Dualvir is used for the treatment of chronic hepatitis C virus (HCV) infection.
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Take it with food, preferably at the same time everyday.
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You will usually need to take this medicine every day for either 12 or 24 weeks.
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Skipping doses increases the risk of treatment failure. Make sure that you take all your doses at the correct time.
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It may cause fatigue, dizziness, and blurred vision. Don’t drive or do anything requiring concentration until you know how it affects you.
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Dualvir may cause headaches. Drink plenty of water and take a suitable painkiller. Inform your doctor if it does not go away.
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Your doctor may monitor your liver function and the amount of hepatitis C virus in your body regularly.
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Do not stop taking this medicine without your doctor’s advice.
Chronic hepatitis C (CHC), genotype 1, 4 & 6 infection in adults.
Oral
Hepatitis C
Indicated for adults with chronic hepatitis C virus (HCV) genotypes 1, 4, 5, or 6 infection
Recommended dosage: One tablet (90 mg of Ledipasvir and 400 mg of Sofosbuvir) taken once daily.
Recommended treatment duration:
Treatment-naive with or without cirrhosis: 12 weeks
Treatment-experienced without cirrhosis: 12 weeks
Treatment-experienced with cirrhosis: 24 weeks
Hepatic impairment
Mild, moderate, or severe: No dosage adjustment required
Decompensated cirrhosis: Safety and efficacy not established
Renal impairment
Mild or moderate: No dosage adjustment required
Severe (eGFR <30 mL/min/1.73 m²) or ESRD: No dosage recommendation can be given
Ledipasvir is an HCV NS5A inhibitor and Sofosbuvir is a nucleotide analog inhibitor of HCV NS5B polymerase.
Ledipasvir is a potent inhibitor of HCV NS5A, a viral phosphoprotein that plays an important role in viral replication, assembly, and secretion. Sofosbuvir is a nucleotide analog inhibitor of hepatitis C virus NS5B polymerase—the key enzyme mediating HCV RNA replication. The triphosphate form of sofosbuvir (GS-461203) mimics the natural cellular uridine nucleotide and is incorporated by the HCV RNA polymerase into the elongating RNA primer strand, resulting in chain termination.
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 Ledipasvir and Sofosbuvir combination is not recommended. In patients without viable treatment options, cardiac monitoring is recommended.
Lactation: Unknown if distributed in human breast milk
>10%
Asthenia (31-36%),Fatigue (4-18%),Headache (13-29%),Cough (5-11%)
1-10%
Nausea (6-9%),Diarrhea (3-7%),Dizziness (1-5%),Dyspnea (3-9%),Insomnia (3-6%),Increased bilirubin >1.5 x ULN (<1 to 3%),Increased lipase >3 x ULN (<1 to 3%),Myalgia (4-9%),Irritability (7-8%)
Frequency Not Defined
Asymptomatic creatine kinase elevation, Grades 3/4
Reduced therapeutic effect w/ drugs that are potent P-gp inducers in the intestine (eg rifampicin, St. John’s wort, carbamazepine & phenytoin), modafinil, phenobarb/oxcarbazepine, rifabutin/rifapentine. P-gp &/or BCRP inhibitors. May result in serious symptomatic bradycardia when co-administered w/ amiodarone in combination w/ another direct acting antiviral.
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