Substance / Medication

Elbasvir

Overview

Active Ingredient
elbasvir
RxNorm CUI
1734628

Indications

® ZEPATIERis indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 or 4 infection in adult and pediatric patients 12 years of age and older or weighing at least 30 kg. Dosage and Administration (2.2) [see] ZEPATIER is indicated for use with ribavirin in certain patient populations.

Labeler: Merck Sharp & Dohme LLCUpdated: 2024-07-05T00:00:00.000ZFull label on DailyMed

Boxed Warning

FDA Black Box Warning

Warnings and Precautions (5.1) [see]. Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with ZEPATIER. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct actin

Contraindications

When this intervention should not be used

Warnings and Precautions (5.2) Use in Specific Populations (8.9) Clinical Pharmacology (12.3) [see,, and] ZEPATIER is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) due to the expected significantly increased grazoprevir plasma concentration and the increa

Indications & Related Conditions

Conditions associated via SNOMED clinical relationships

Administration & Protocol

Dosing, route, and treatment protocol

Detailed dosage and administration information is available in the full FDA drug label.

View full prescribing information on DailyMed

Monitoring & Follow-Up

Biomarkers relevant to this intervention via related conditions

No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.

Clinical Trials

8 trials linked to this intervention

8
Total Trials
0
Recruiting
7
With Results

Research Evidence

Published studies and systematic reviews

Sort:
Cost-Effectiveness of Elbasvir/Grazoprevir for the Treatment of Chronic Hepatitis C: A Systematic Review.
Liu Jinyu, Guo Min, Ke Lei et al. · Front Public Health · 2022
PMID: 35646774Meta-AnalysisFull text (PMC)
Safety and tolerability of elbasvir/grazoprevir in chronic hepatitis C virus therapy: Integrated analysis from clinical trials.
Nangia Gayatri, Vierling John M, Kwo Paul et al. · J Viral Hepat · 2020
PMID: 32594612Meta-Analysis
Pharmacokinetic similarity demonstrated after crushing of the elbasvir/grazoprevir fixed-dose combination tablet for HCV infection.
Pijnenburg Daniëlle W M, van Seyen Minou, Abbink Evertine J et al. · J Antimicrob Chemother · 2020
PMID: 32544221RCTFull text (PMC)
Elbasvir/grazoprevir and sofosbuvir for hepatitis C virus genotype 3 infection with compensated cirrhosis: A randomized trial.
Foster Graham R, Agarwal Kosh, Cramp Matthew E et al. · Hepatology · 2018
PMID: 29473975RCT
Real-world use of elbasvir-grazoprevir in patients with chronic hepatitis C: retrospective analyses from the TRIO network.
Flamm S L, Bacon B, Curry M P et al. · Aliment Pharmacol Ther · 2018
PMID: 29665097RCT
Susceptibilities of genotype 1a, 1b, and 3 hepatitis C virus variants to the NS5A inhibitor elbasvir.
Liu Rong, Curry Stephanie, McMonagle Patricia et al. · Antimicrob Agents Chemother · 2015
PMID: 26303801RCTFull text (PMC)
Validated LC/MS method for simultaneous determination of elbasvir and grazoprevir in human plasma.
Labidi Aymen, Bensghaier Rafika, Jebali Sami et al. · Ann Pharm Fr · 2024
PMID: 38823440Observational

Research data from MEDLINE/PubMed

Benefits & Expected Outcomes

Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.

Risks & Side Effects

Adverse reaction and safety data for this drug is sourced from the FDA-approved label.

View adverse reactions & drug interactions on DailyMed

Related Symptoms

Symptoms associated with conditions this intervention addresses

No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.

Alternatives & Comparisons

Alternative treatments, comparison data, and clinical decision support are pending physician authorship.

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.

Do not start, stop, or change any treatment without consulting your healthcare provider.

Quick Facts

Type
Substance / Medication
Fully Specified Name
Elbasvir (substance)
SNOMED CT
716042006
UMLS CUI
C4080052
RxNorm CUI
1734628
Labeler
Merck Sharp & Dohme LLC

Clinical Data

This intervention maps to 2 entities in the Ltrl knowledge graph.

2
Conditions
0
Biomarkers
0
Specialists
0
Symptoms
8
Clinical Trials

Data is sourced from SNOMED CT, UMLS, and the Ltrl clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.