Daclahep is a drug which belongs to anti-hepatitis C viral medication, andcontains composition of Daclatasvir as an anti-viral agent. Daclahep is a type of HCV NS5A inhibitor. Daclahep is an orally available prohibitor of HCV NS5A replication complex with potent anti-viral activity. Daclahep contains Daclatasvir is not usually used as monotherapy it should be combined wuith other anti-viral agents especially sofosbuvir or ribavirin for better activity against HCV infection. The drawback of Daclahep therapy; Loss of virological response occurs in HCV genotype III infected patients with cirrhosis getting Daclatasvir in combination with sofosbuvir for 12 weeks.
The pharmacological category of Daclahep is; Anti-hepaciviral drug NS5A inhibitor The major indication of Daclahep is involved to treat chronic hepatitis C viral infection caused by genotypes I or III.
Daclatasvir performs action of HCV NS5A inhibitor. After oral organization, converge to space I of NS5A protein and forbids the movement of NS5A protein and finishes up as disturbance of viral RNA replication complex, discourage the viral RNA creation and disallows the viral replication.
The maximal plasma concentration time of Daclahep is occurs within 2 hours.
Bioavailability of Daclahep is occurs by 67%
No food should be altering the absorption of Daclahep; it should be taken with or without food.
The human plasma protein binding effect of Daclahep is 99%. The apparent volume of distribution is 47L Daclahep metabolism is mediated by cytochrome enzymes like CYP3A4.
Daclahep is eliminated in feces by 88% & urine by 6.6%. The half-lives of Daclahep is almost 15 to 15 hours
Prior to thestarting of the treatment with Daclahep , patients HBsAg & anti HBc values are calculated for preventing the reoccurrence of HBV infections. Daclatasvir should be concomitant use with Sofosbuvir. The general dose of Daclahep is 60mg should be administered with or without food.
Patients without cirrhosis: Daclahep + sofosbuvir should be taken orally for 12 weeks. Patients with compensated cirrhosis: one Daclahep+400mg of sofosbuvir for 12 weeks Patients with decompensated cirrhosis or liver transplanted patients: one Daclahep +400mg of sofosbuvir + ribavirin for 12 weeks.
Patients without cirrhosis: Daclahep + sofosbuvir should be taken orally for 12 weeks. Patients with compensated or decompensated cirrhosis: one Daclahep + 400mg of sofosbuvir + ribavirin for 12 weeks.
Dosage alteration due to drug interaction:
Daclahep combined with CYP3A inhibitors & HIV antiviral agents, the dose should be reduced to 30mg as once a day. Daclahep with CYP3A inducers, the dose of Daclahep is increased to 90mg once daily Avoid the combination of Daclahep with potent CYP3A inducers
At the time of over dosage, patient should be treated with general supportive measures. The signs & symptoms of Daclahep over dosage should be monitored. No special antidote is required for treating the over dosage of Daclahep. It is difficult to remove by hemodialysis, because Daclahep is majorly binds to human plasma protein with range of 99%.
Daclahep side effects
Symptomatic bradycardia while combining with amiodarone Nausea, Diarrhea, Insomnia, Dizziness, Somnolence, Anemia, Increased AST, ALT, Increased bilirubin, Headache, Fatigue, Increased lipase
Loss of virological response occurs due to drug interactions:
The combination of Daclahep with other anti-viral agents sometimes leads to cause loss of activity of Daclahep & produce resistance. Prevent this type of combination therapy. Monitor the adverse effects due to drug interactions frequently.
This fatal case is occurs due to concomitant use of Daclahep with amiodarone. Prevent the problem by avoiding this combination. ECG should be monitored Alternative measures should be provided Patient should be counseled about the risk benefits associated with this combination.
Exposure of adverse effects related to ribavirin:
The combination of Daclahep with ribavirin should be contraindicated to pregnancy condition.
Warning associated with Daclahep
HBV reactivation in patient’s co infected with HCV/HBV;
This condition is occurs majorly in the patients who are receiving the anti-HCV therapy, but not getting treatment for HBV infection.
Prevent the problem by testing the patients HBsAg & anti-HBc levels before the treatment starts. Hepatic function test should be performed. Patients management associated with HBV infection should be started.