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Daclahep mechanism of action

Daclahep is a NS5A inhibitors, NS5A protein is required for viral multiplication This NS5A inhibitor has efficiency to incorporate with HCV RNA. There are two essential mechanism in RNA proliferation which is based on phosphorylated state Cis acting function of phosphorylated NS5A: interfering HCV replication complex Trans acting function: regulate HCV assembly and infectious particle production Daclahep will disrupt hyperphosphorylated NS5A protein and mediated with newly formed RNA viral Daclahep involved in blockade of intercellular viral RNA synthesis and colony of virion



The peak plasma concentration of Daclahep occurs within 2 hours. The mean bioavailability of Daclahep is 67%


The volume of distribution occurs at 47L. The human plasma protein bound with Daclahep with the range of 99%


Daclahep a CYP3A substrates, it is dominantly metabolized by CYP3A4 isoenzymes High portion of drug in plasma is in unchanged mode nearly 97%


The route of elimination of metabolites; Elimination of drug via Bile: 88%; feces 53% (unchanged form) and 6.6% in unchanged form through urine The mean terminal half life period of Daclahep occurs from the range of almost 12 to 15 hours


Brand : Daclahep
Ingredients : Daclatasvir
Strength : 60mg
Manufactured : Hetero
Package : 28 tablets

Dosage and administration of Daclahep

Before initiating the therapy; NS5A resistance testing in HCV genotype 1a infected patients with cirrhosis has been evaluated The usual dose of Daclahep is 60mg as a single dose Recommended dosage regimens:

Genotype I

Without cirrhosis: Daclahep + Sofosbuvir for 12 weeks Compensated cirrhosis (child Pugh A): Daclahep + Sofosbuvir for 12 weeks Decompensated cirrhosis (child Pugh B or C): Daclahep + Sofosbuvir + ribavirin for 12 weeks

Genotype III

Without cirrhosis: Daclahep with Sofosbuvir for 12 weeks Compensated or decompensated cirrhosis: Daclahep with Sofosbuvir + ribavirin for 12 weeks

Dose adjustments

While concomitant with strong CYP3A inhibitors: 30mg of Daclahep once a day Concomitant with moderate CYP3A inducers & nevirapine: 90mg of Daclahep as single dose With strong CYP3A inducers: contraindicated Daclahep should be administered with or without food

Side effects of Daclahep

While using the drug Some common side effects occurred as follows:: Chest pain, dizziness Irregular heart beat Unusual tiredness More common: Headache, nausea Pharmacological effects:


Pyrexia , hot flush, loss of weight, Fatigue, asthenia, influenza like symptoms


Headache, migraine, somnolence


Rashes, Pruritus, dry skin, alopecia, and Erythema multiforme


Insomnia, irritability, depression, anxiety


Anemia, neutropenia, thrombocytopenia, esinophillia


Cough, Nasopharyngitis, dyspnea, nasal congestion, upper respiratory infection


Gastro esophageal reflux, vomiting, Abdominal pain, elevated lipase, flatulence


Myalgia, arthralgia, back pain


Loss of appetite


Bradycardia, heart block, cardiac arrhythmias


Increased AST & ALT, Hyperbilirubinaemia, hepatitis B reactivation


Urinary tract infection


Dry eye


Drug interaction

Concurrent use of Daclahep with some drugs likes; Amiodarone: serious bradycardia occurs Aprepitant: increase the serum concentration of CYP3A4 substrates Strong inducers of CYP3A causes decreased therapeutic effect of Daclahep Daclahep is an inhibitor of P-glycoprotein transporter, organic anion transporting polypeptide and breast cancer resistance protein; taking Daclahep , may elevate exposure to these drugs, which prolong the therapeutic effect Proteases inhibitors: increase effect of concentration of Daclahep Efavirenz, etravirine & nevirapine: decrease the effect of concentration of Daclahep Strong CYP3A inhibitors: increase the effect of concentration of Daclahep Interaction with HMG CoA reductase will increase the effect of concentration of these lipid lowering drugs.

Precaution and warning

There is a risk of adverse effects due to concurrent use of Daclahep with some other drugs may causes; Loss of therapeutic effect Serious life threatening conditions Symptomatic bradycardia while using with amiodarone Risk related to ribavirin during combination Hepatitis B reactivation

abdominal pain
abdominal pain
concluded as death
concluded as death
dark urine
dark urine
flu like syndrome
flu like syndrome
loss of apetite
loss of apetite
loss of weight
loss of weight

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