ONE REGIMEN, ALL GENOTYPES, 8 WEEKS

Transcription

1 For UK healthcare professionals only INTRODUCING MAVIRET ONE REGIMEN, ALL GENOTYPES, 8 WEEKS FOR TREATMENT-NAÏVE, NON-CIRRHOTIC PATIENTS 1 Maviret is indicated for the treatment of chronic hepatitis C virus (HCV) infection, genotypes 1-6, in adults with compensated liver disease. 1 You are strongly advised to read the Prescribing Information (PI), which can be found on page 6. This information is available to view or download from

2 NON-CIRRHOTIC PATIENTS HIGH SVR1 RATES ACHIEVED IN GT 1-6 PATIENTS -6 * SVR1 (%) Data from the ENDURANCE 1 and 3, and SURVEYOR 1 and studies in non-cirrhotic patients, including treatment-naive patients who received 8 weeks of Maviret treatment. Data includes results from GT 1,, 4, 5, and 6 patients with prior experience of peginterferon, ribavirin, and/or sofosbuvir. GT 3 patients included in this analysis were treatment-naive only % GT 1 99% % % 99% % % * mitt population excluded patients who did not achieve SVR1 for reasons other than virologic failure. ITT values were the primary endpoint. Populations included in the ITT analyses varied, please refer to the study information for more details. ITT: intention-to-treat, mitt: modified intention-to-treat. 96% % ITT GT GT 3 GT 4 GT 5 GT 6 Data from open-label and non-randomised or part-randomised registrational studies. mitt 10 % 97SVR1 Across GT 1-6 (n=807/88) with 8 weeks of therapy in non-cirrhotic patients (pooled analysis; 79% treatment-naïve, n=657/88). 6 % 99SVR1 (n=807/816) ITT mitt mitt population excluded patients who did not achieve SVR1 for reasons other than virologic failure. 6 Data were pooled from the 8-week arms of the SURVEYOR 1 and, EXPEDITION 4 and ENDURANCE 1,, 3, and 4 studies. GT 3 patients included in this analysis were treatment-naïve only. 6

3 STRAIGHTFORWARD 8-WEEK PANGENOTYPIC TREATMENT 1 NS5A INHIBITOR PIBRENTASVIR 1 NS3/4A PROTEASE INHIBITOR GLECAPREVIR 1 MAVIRET COMBINES NEW, POTENT* ANTIVIRAL AGENTS 1,7,8 No ribavirin required 1 No baseline resistance or viral load testing needed 1 ONCE DAILY Once-daily dosing 1 *Based on in vitro EC 50 values of glecaprevir and pibrentasvir against full-length or chimeric replicons encoding NS3 or NS5A from laboratory strains and chimeric replicons from clinical isolates. 7,8 The clinical significance of in vitro data is unclear. 3

4 A GENERALLY WELL TOLERATED TREATMENT REGIMEN 1 ADVERSE EVENTS In phase /3 studies (N=,65), most commonly reported adverse events ( 1 of patients) were headache and fatigue. Other reported adverse events were asthenia, nausea and diarrhoea 1,9 DISCONTINUATIONS DUE TO ADVERSE EVENTS <1% discontinuation rate due to adverse events across phase /3 studies (N=,65) 9 No requirement for routine LFT monitoring during treatment 1 <1% clinically significant elevations (Grade 3) in ALT or bilirubin levels with use of Maviret (N=,63) 9 No dose adjustment required in renally impaired patients 1 Including patients on dialysis Data presented on this page were pooled from SURVEYOR 1 and, EXPEDITION 1, MAGELLAN 1, and ENDURANCE 1,, 3, and 4 studies. 9 For comprehensive safety information regarding drug-drug interactions, contraindications, adverse events and precautions for Maviret, please refer to the Maviret Summary of Product Characteristics. Please see the full Prescribing Information on page 6. ALT: alanine aminotransferase, LFT: liver function test. 4

5 TREATMENT-NAÏVE, NON-CIRRHOTIC PATIENTS ONE REGIMEN, ALL GENOTYPES, 8 WEEKS 1 HIGH CURE* RATES 6 97% SVR1 (n=807/88) pooled across GT 1-6 with 8 weeks of therapy in non-cirrhotic patients (ITT; 79% treatment-naïve) RBV FREE STRAIGHTFORWARD REGIMEN 1 No ribavirin required No baseline resistance or viral load testing needed No requirement for routine LFT monitoring during treatment Once-daily dosing TOLERABILITY GENERALLY WELL TOLERATED 9 In phase /3 studies (N=,65): <1% discontinuation rate due to adverse reactions The most common adverse events ( 1 of patients) were headache and fatigue. Other reported adverse events were asthenia, nausea and diarrhoea HOW MANY OF YOUR PATIENTS CAN MOVE FORWARD IN 8 WEEKS WITH MAVIRET? * Cure = sustained virologic response (SVR1), defined as HCV RNA less than lower limit of quantification (LLOQ) at 1 weeks after the end of treatment and was the primary endpoint in all the studies. 1 ITT: intention-to-treat, LFT: liver function test, RBV: ribavirin. 5

6 PRESCRIBING INFORMATION MAVIRET 100 mg/40 mg film-coated tablets PRESCRIBING INFORMATION PRESENTATION: Each Maviret film-coated tablet contains 100 mg of glecaprevir and 40 mg pibrentasvir. Please refer to the Summary of Product Characteristics (SmPC) before prescribing. INDICATION: For treatment of Chronic hepatitis C Virus (HCV) infection in adults. DOSAGE AND ADMINISTRATION: Oral. Treatment to be initiated and monitored by physician experienced in HCV management. Dosage: The recommended dose of Maviret is 300 mg/10 mg (three 100 mg/40 mg tablets), taken orally, once daily with food. Treatment Duration: Patients without prior therapy (GT 1-6): No cirrhosis: 8 weeks. Patients with compensated cirrhosis: 1 weeks. Patients who failed prior therapy with peg-ifn + ribavirin +/- sofosbuvir, or sofosbuvir + ribavirin: GT 1,, 4-6 and no cirrhosis: 8 weeks. GT 1,, 4-6 and cirrhosis: 1 weeks. GT3 with or without cirrhosis: 16 weeks. Special Populations: HIV Co-infection: No dose adjustment required. For dosing with HIV antiviral agents refer to SmPC for additional information. Liver Transplant recipients: 1 weeks in liver transplant recipients, with 16 weeks considered for GT3 patients who are treatment experienced as above. Elderly: No dose adjustment required. Renal impairment: No dose adjustment required. Hepatic impairment: No dose adjustment required in patients with mild hepatic impairment (Child-Pugh A). Not recommended in patients with moderate hepatic impairment (Child-Pugh B) and contraindicated in patients with severe hepatic impairment (Child-Pugh C). Paediatric Population: No data available. CONTRAINDICATIONS: Hypersensitivity to any of the active substances or excipients. Concomitant use with atazanavir containing products atorvastatin, simvastatin, dabigatran etexilate, and ethinyl oestradiol-containing products. Maviret in combination with strong Pgp and CYP3A inducers: examples include; carbamazepine, phenytoin, phenobarbital, primidone, rifampicin, St. John s Wort (Hypericum perforatum). SPECIAL WARNINGS AND PRECAUTIONS: Hepatitis B virus (HBV) screening should be performed in all patients prior to treatment. HBV/HCV co-infected patients are at risk of HBV reactivation, and should be monitored and managed according to current clinical guidelines. No re-treatment data is available for patients infected with genotypes, 3, 5 or 6. Maviret is not recommended for the re-treatment of patients with prior exposure to NS3/4A- and/or NS5A-inhibitors. Maviret contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Safety and Efficacy of Maviret post-liver transplant have not yet been assessed. INTERACTIONS: See SmPC for full details. Not Recommended: darunavir, efavirenz, lopinavir/ritonavir, lovastatin, ciclosporin doses > 100 mg daily, moderate inducers of P-gp/CYP3A. Use Caution: digoxin, pravastatin, fluvastatin, pitavastatin, rosuvastatine, tacrolimus. Monitor Levels: Monitor INR with all vitamin K antagonists. Coadministration with P-gp, BCRP or OATP1B1/3 inhibitors may increase antiviral concentrations. PREGNANCY AND LACTATION: Pregnancy: not recommended. Lactation: It is not known whether Maviret and its metabolites are excreted in breast milk. Fertility: No human data on the effect of glecaprevir and/or pibrentasvir are available. SIDE EFFECTS: See SmPC for full details on side effects. Very common side effects ( 1/10): headache, fatigue. Common side effects ( 1/100 to <1/10): diarrhoea, nausea, asthenia. Less than 0.1% of subjects treated with Maviret had serious adverse reactions. LEGAL CATEGORY: POM MARKETING AUTHORISATION NUMBERS/PRESENTATIONS/BASIC NHS COST: Maviret 100 mg/40 mg film-coated tablets; daily blister packs containing 3 film-coated tablets, inner cartons containing 1 film-coated tablets in multipack presentation containing 84 (4 packs of 1) film-coated tablets. EU/1/17/113/001: 1, MARKETING AUTHORISATION HOLDER: AbbVie Ltd, Maidenhead, SL6 4UB DATE OF REVISION: February 018 Maviret-PI-00 Adverse events should be reported. Reporting forms and information can be found at Adverse events should also be reported to AbbVie on ukadverseevents@abbvie.com REFERENCES: 1. Maviret Summary of Product Characteristics. AbbVie Ltd. Available at Zeuzem S et al. N Engl J Med 018; 378: Kwo PY et al. J Hepatol. 017; 67(): Asselah T et al. Clin Gastroenterol Hepatol pii: S (17)3116-X. doi: /j.cgh Foster G et al. [Oral presentation #73]. Presented at the European Association for the Study of the Liver. April 19 3, 017. Amsterdam, The Netherlands. 6. Puoti M et al. [Poster SAT-33]. Presented at the European Association for the Study of the Liver. April 19 3, 017. Amsterdam, The Netherlands. 7. Ng T et al. Antimicrob Agents Chemother. 017; 61(5): e Ng T et al. Antimicrob Agents Chemother. 017; 6(1): e Dufour J-F et al. [Poster FRI-38]. Presented at the European Association for the Study of the Liver. April 19 3, 017. Amsterdam, The Netherlands. Date of preparation March 018 AXHCV1800 6