Clinical Pharmacology Details


Daclatasvir


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Indications & Dose:

In combination with sofosbuvir for the treatment of chronic hepatitis C infection of genotypes 1 or 4,with or without compensated cirrhosis | In combination with sofosbuvir and ribavirin for the treatment of chronic hepatitis C infection of genotype 3 in patients who are treatment experienced, with or without compensated cirrhosis | In combination with peginterferon alfa and ribavirin for the treatment of chronic hepatitis C infection of genotype 4



Adult: Usual dose 60 mg once daily (for duration of treatment consult product literature)


DOSE ADJUSTMENTS DUE TO INTERACTIONS Reduce dose to 30mg once daily with concomitant use of potent CYP3A4 inhibitors (e.g. atazanavir boosted with ritonavir, boceprevir, clarithromycin, cobicistat, itraconazole, ketoconazole, posaconazole, telaprevir, telithromycin, and voriconazole). Increase dose to 90 mg once daily with concomitant use of moderate CYP3A4 inducers (e.g. efavirenz). 

Contraindications:

Side Effects:

Common or very common Abdominal pain . alopecia . anaemia . anxiety . arthralgia . blurred vision . constipation . cough . decreased appetite . depression . diarrhoea . disturbance in attention . dizziness . dry mouth . dry skin . dyspnoea . flatulence . gastro-oesophageal reflux . headache . hot flush . insomnia . irritability . lymphopenia . malaise . migraine . myalgia . nasal congestion . nausea . neutropenia . pruritus . pyrexia . rash . reduced visual acuity . vomiting 


CONCEPTION AND CONTRACEPTION


Highly effective contraception required during and for 5 weeks after treatment.


BREAST FEEDING Manufacturer advises avoid—present in milk in animal studies.


 

Cautions:

Decompensated liver disease . hepatitis B virus co-infection . human immunodeficiency virus coinfection . organ transplant patients . retreatment—efficacy not established in patients with prior exposure to a NS5A inhibitor 


 

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