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.


  • 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

למידע נוסף יש לעיין בעלון לרופא המופיע באתר משרד הבריאות


אני מעוניין לקבל מידע נוסף מנציג חברת אבווי



סימוכין
  1. 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.
  2. 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.
  3. 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)
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.