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Daklinza is a drug for the treatment of hepatitis C (HCV). Daclatasvir inhibits the HCV nonstructural protein NS5A. Recent research suggests that it targets two steps of the viral replication process, enabling rapid decline of HCV RNA.
Daklinza is indicated for use with sofosbuvir, with or without ribavirin, for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 or genotype 3 infections.
The concomitant use of Daklinza and other drugs may result in known or potentially significant drug interactions, some of which may lead to loss of therapeutic effect of Daklinza and possible development of resistance, dosage adjustments of concomitant medications or Daklinza, possible clinically significant adverse reactions from greater exposures of concomitant drugs or Daklinza.
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Postmarketing cases of symptomatic bradycardia and cases requiring pacemaker intervention have been reported when amiodarone is coadministered with sofosbuvir in combination with another HCV direct-acting antiviral, including Daklinza.
A fatal cardiac arrest was reported in a patient receiving a sofosbuvir-containing regimen (ledipasvir/sofosbuvir). Bradycardia generally resolved after discontinuation of HCV treatment. The mechanism for this bradycardia effect is unknown.
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Most common side effects occurred during the trials in combination with sofosbuvir (with or without ribavirin), with peginterferon alfa/ribavirin, with asunaprevir, or with asunaprevir/peginterferon alfa/ribavirin are such: fatigue, headache, pruritus, insomnia, influenza-like illness, dry skin, nausea, decreased appetite, alopecia, rash, asthenia, irritability, myalgia, anemia, pyrexia, cough, dyspnea, neutropenia, diarrhea, arthralgia, neutropenia, anemia, thrombocytopenia, and lymphopenia.
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