בטיחות
פרופיל בטיחות: 8 שבועות מבירט
בחולי HCV עם שחמת מפוצה, גנוטיפים 1-6, שלא טופלו בעבר
EXPEDITION-8 – MAVIRET FOR 8 WEEKS IN TREATMENT-NAIVE, COMPENSATED CIRRHOTIC PATIENTS: SAFETY1
No drug-related serious adverse events or discontinuations due to adverse events occurred. Clinically significant laboratory abnormalities were infrequent.
* Duodenal ulcer hemorrhage and gastric adenocarcinoma (n=1);
pyelonephritis (n=1); atrial fibrillation and cardiac failure (n=1);
peripheral edema (n=1); pneumonia (n=1); bronchitis (n=1);
†Leukopenia and neutropenia (n=1).
ALT=alanine aminotransferase
AST=aspartate aminotransferase
CC=compensated cirrhosis
TN=treatment-naïve
ULN=upper limit of normal
פרופיל בטיחות: 8 שבועות מבירט2
בחולי HCV, נאיביים GT1, 2, או 4-6 ללא שחמת ועם שחמת מפוצה
Data from pooled analysis of eight - pre- and post-approval (N = 1163)
Maviret was well tolerated, treatment-related serious AEs and discontinuations due to AEs and laboratory abnormalities of Grade ≥3 were rare and were not consistent with drug-induced liver injury.
Zuckerman E, EASL 2019 Poster Presentation THU-198.
פרופיל בטיחות: 8 שבועות מבירט1,3
בחולי HCV ללא שחמת ועם שחמת מפוצה, גנוטיפים 1-6, שלא טופלו בעבר
Data from EXPEDITION 8 study.1
Data were pooled from nine phase II and III trials. 3
- רוב תופעות הלוואי היו קלות בחומרתן1,3
- סוג וחומרת תופעות לוואי בנבדקים עם שחמת מפוצה היו דומים בסך הכל לאלו שנצפו במטופלים ללא שחמת.3
אני מעוניין לקבל מידע נוסף מנציג חברת אבווי
סימוכין
- Brown RS, Buti M, Rodrigues L, et al. Glecaprevir/pibrentasvir for 8 weeks in treatment-naive patients with chronic HCV genotypes 1–6 and compensated cirrhosis: the EXPEDITION-8 trial. J Hepatol 2020, vol.72/441-449.
- Eli Z et. al. Efficacy and Safety of Glecaprevir/Pibrentasvir Treatment for 8 Weeks in Treatment-Naïve Patients With Chronic Hepati tis C Virus Infecti on Without Cirrhosis or With Compensated Cirrhosis: Analysis of Data Pooled From Phase 2 and 3 Studies. EASL 2019, poster THU-198.
- Puoti M, Foster GR, Wang S, et al. High SVR12 with 8-week and 12-week glecaprevir/pibrentasvir therapy: an integrated analysis of HCV genotype 1–6 patients without cirrhosis. J Hepatol. 2018;69(2):293-300. doi:10.1016/j. jhep.2018.03.007.
יש לדווח תופעות לוואי ל Abbvie במייל: PVIsrael@abbvie.com
יש לדווח תלונות איכות ל Abbvie במייל: QAIsrael@abbvie.com
Summary of Safety Information* 14 May 2022
MAVIRET® (100 mg glecaprevir/ 40 mg pibrentasvir)
MAVIRET® (100 mg glecaprevir/ 40 mg pibrentasvir)
INDICATION: For treatment of Chronic hepatitis C Virus (HCV) infection in adults and in ad-olescents aged 12 to <18 years.
CONTRAINDICATIONS: Hypersensitivity to the active substances or excipients. Moderate to severe hepatic impairment (Child Pugh B or C) or those with any history of prior hepatic decom-pensation. Concomitant use with atazanavir containing products, atorvastatin, simvastatin, dabigatran etexilate, ethinyl estradiol-containing products, strong P-gp and CYP3A inducers (e.g., rifampicin, carbamazepine, St. John’s wort (Hypericum perforatum), phenobarbital, pheny-toin, andprimidone).
DOSAGE AND ADMINISTRATION: Adults and adolescents aged 12 to <18 years: The rec-ommended dose of Maviret is 300 mg/120 mg (three 100 mg/40 mg tablets), taken orally, once daily at the same time with food. Special Populations: No dose adjustment required in HIV Co-infection, Elderly, Renal impair-ment, mild Hepatic impairment (Child-Pugh A).
SPECIAL WARNINGS AND PRECAUTIONS: HBV screening should be performed in all patients before initiation of treatment. HBV/HCV co-infected patients are at risk of HBV reacti-vation, and should, therefore, be monitored and managed according to current clinical guidelines. Postmarketing cases of hepatic decompensation/failure, including those with fatal outcomes, have been reported in patients treated with HCV NS3/4A protease inhibitor-containing regimens, including Maviret. The majority of patients with severe outcomes had evidence of advanced liver disease with moderate or severe hepatic impairment (Child-Pugh B or C) prior to initiating ther-apy with Maviret, including some patients reported as having compensated cirrhosis with mild liver impairment (Child-Pugh A) at baseline but with a prior decompensation event. Rare cases of hepatic decompensation/failure were reported in patients without cirrhosis or with compen-sated cirrhosis (Child-Pugh A); many of these patients had evidence of portal hypertension. Events also occurred in patients taking a concomitant medication not recommended for coadmin-istration, or in patients with confounding factors such as serious liver related medical or surgical comorbidities. Cases typically occurred within the first 4 weeks of treatment (median of 27 days). In patients with compensated cirrhosis (Child Pugh A) or evidence of advanced liver dis-ease, perform hepatic laboratory testing and monitor for signs and symptoms of hepatic decom-pensation such as the presence of jaundice, ascites, hepatic, encephalopathy, and variceal hemor-rhage. Discontinue Maviret in patients who develop evidence of hepatic decompensation/failure. Maviret is not recommended for the re-treatment of patients with prior exposure to NS3/4A- and/or NS5A-inhibitors. Glucose levels of diabetic patients initiating direct acting antiviral ther-apy should be closely monitored, particularly within the first 3 months, and their diabetic medi-cation modified when necessary.
Maviret contains lactose: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal prod-uct.
Maviret contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘so-dium-free’.
INTERACTIONS: 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.
Monitor patients in case ciclosporin doses exceed >100 mg per day. Co-administration with Pgp, BCRP or OATP1B1/3 inhibitors may increase antiviral concentrations and patients should be monitored.
SIDE EFFECTS: Very common side effects (≥1/10): headache, fatigue. Common side effects (≥1/100 to <1/10): diarrhoea, nausea, asthenia, and elevation in total bilirubin. Uncommon side effects (≥1/1,000 to <1/100): angioedema. Not known (cannot be estimated from available data): pruritus.
* For full information please see MAVIRET prescribing information.
Full prescribing information can be received from Abbvie Biopharmaceuticals LTD Israel at 4 Hacharash St., Neve Ne’eman, Hod Hasharon 4524075. Telephone number: +972-9-7909600, Fax number: +972-9-7909606.
Monitor patients in case ciclosporin doses exceed >100 mg per day. Co-administration with Pgp, BCRP or OATP1B1/3 inhibitors may increase antiviral concentrations and patients should be monitored.
SIDE EFFECTS: Very common side effects (≥1/10): headache, fatigue. Common side effects (≥1/100 to <1/10): diarrhoea, nausea, asthenia, and elevation in total bilirubin. Uncommon side effects (≥1/1,000 to <1/100): angioedema. Not known (cannot be estimated from available data): pruritus.
* For full information please see MAVIRET prescribing information.
Full prescribing information can be received from Abbvie Biopharmaceuticals LTD Israel at 4 Hacharash St., Neve Ne’eman, Hod Hasharon 4524075. Telephone number: +972-9-7909600, Fax number: +972-9-7909606.