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PIBRENTASVIR
PIBRENTASVIR is a Hepatitis C Virus NS5A Inhibitor [EPC] drug. It is currently FDA-approved (first approved 2017).
At a glance
| Generic name | PIBRENTASVIR |
|---|---|
| Drug class | Hepatitis C Virus NS5A Inhibitor [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2017 |
Approved indications
Boxed warnings
- WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with MAVYRET. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated [see Warnings and Precautions ( 5.1 )] . WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV See full prescribing information for complete boxed warning. Hepatitis B virus (HBV) reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death. ( 5.1 )
Common side effects
- Headache
- Fatigue
- Nausea
- Diarrhea
- Pruritus
- Asthenia
Key clinical trials
- Study of Glecaprevir/Pibrentasvir to Assess Safety Through Real-World Data
- Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV (PHASE1, PHASE2)
- Feasibility and Acceptability of HCV Treatment in Pregnancy
- A Study to Evaluate Preemptive Therapy in Hepatitis C (HCV) Organ Transplant Recipients (PHASE4)
- Rapid HCV Treatment Access for Persons Who Use Drugs (NA)
- A Study of the Safety, Effectiveness and Clinical Use of Maviret in Adolescent Patients With Chronic Hepatitis C Virus
- Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder (PHASE2, PHASE3)
- Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- PIBRENTASVIR CI brief — competitive landscape report
- PIBRENTASVIR updates RSS · CI watch RSS
Frequently asked questions about PIBRENTASVIR
What is PIBRENTASVIR?
PIBRENTASVIR is a Hepatitis C Virus NS5A Inhibitor [EPC] drug.
What drug class is PIBRENTASVIR in?
PIBRENTASVIR belongs to the Hepatitis C Virus NS5A Inhibitor [EPC] class. See all Hepatitis C Virus NS5A Inhibitor [EPC] drugs at /class/hepatitis-c-virus-ns5a-inhibitor-epc.
When was PIBRENTASVIR approved?
PIBRENTASVIR was first approved on 2017.
What development phase is PIBRENTASVIR in?
PIBRENTASVIR is FDA-approved (marketed).
What are the side effects of PIBRENTASVIR?
Common side effects of PIBRENTASVIR include Headache, Fatigue, Nausea, Diarrhea, Pruritus, Asthenia.
Related
- Drug class: All Hepatitis C Virus NS5A Inhibitor [EPC] drugs
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing