Maviret

Maviret treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection. 2). The recommended Maviret treatment durations for HCV genotype 1, 2, 3, 4, 5, or 6 infected patients with compensated liver disease (with or without cirrhosis) are provided in Table 1 and Table 2.

Table 1:

Recommended Maviret treatment duration for patients without prior HCV therapy Genotype Recommended treatment duration No cirrhosis Cirrhosis GT 1, 2, 3, 4, 5, 6 8 weeks 8 weeks 3 Table 2: Recommended Maviret treatment duration for patients who failed prior therapy with peg-IFN + ribavirin +/- sofosbuvir, or sofosbuvir + ribavirin Genotype Recommended treatment duration No cirrhosis Cirrhosis GT 1, 2, 4-6 8 weeks 12 weeks GT 3 16 weeks 16 weeks For patients who failed prior therapy with an NS3/4A- and/or an NS5A inhibitor, see section

Summary of the safety profile In pooled Phase 2 and 3 clinical studies of adult subjects receiving Maviret with genotype 1, 2, 3, 4, 5 or 6 HCV infection the most commonly reported adverse reactions (incidence ≥ 10%) were headache and fatigue.

1% of subjects treated with Maviret had serious adverse reactions (transient ischaemic attack). 1%. Tabulated list of adverse reactions The following adverse reactions were identified in registrational Phase 2 and 3 studies in HCV- infected adults with or without cirrhosis treated with Maviret for 8, 12 or 16 weeks, or during post- marketing experience.

The adverse reactions are listed below by body system organ class and frequency. Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000) or not known (cannot be estimated from the available data).

Table 4:

Adverse reactions identified with Maviret Frequency Adverse reactions Immune system disorders Uncommon angioedema Nervous system disorders Very common headache Gastrointestinal disorders Common diarrhoea, nausea Skin and subcutaneous tissue disorders Not known pruritus General disorders and administration site conditions Very common fatigue Common asthenia Investigations Common elevation in total bilirubin 12 Description of selected adverse reactions Adverse reactions in subjects with severe renal impairment including subjects on dialysis The safety of Maviret in subjects with chronic kidney disease (including subjects on dialysis) and genotypes 1, 2, 3, 4, 5 or 6 chronic HCV infection with compensated liver disease (with or without cirrhosis) was assessed in adults in EXPEDITION-4 (n=104) and EXPEDITION-5 (n=101).

9%) in EXPEDITION-5. Adverse reactions in subjects with liver or kidney transplant The safety of Maviret was assessed in 100 post-liver or -kidney transplant adult recipients with genotypes 1, 2, 3, 4, or 6 chronic HCV infection without cirrhosis (MAGELLAN-2).

4. Missed dose In case a dose of Maviret is missed, the prescribed dose can be taken within 18 hours after the time it was supposed to be taken. If more than 18 hours have passed since Maviret is usually taken, the missed dose should not be taken and the patient should take the next dose per the usual dosing schedule.

Patients should be instructed not to take a double dose. If vomiting occurs within 3 hours of dosing, an additional dose of Maviret should be taken. If vomiting occurs more than 3 hours after dosing, an additional dose of Maviret is not needed.

2). 2). Hepatic impairment No dose adjustment of Maviret is required in patients with mild hepatic impairment (Child-Pugh A). 2). 1). A 16-week treatment duration should be considered in genotype 3-infected patients who are treatment-experienced with peg-IFN + ribavirin +/- sofosbuvir, or sofosbuvir + ribavirin.

Patients with HIV-1 co-infection Follow the dosing recommendations in Tables 1 and 2. For dosing recommendations with HIV antiviral agents, refer to section

1. 2). , rifampicin, carbamazepine, St. 5).