access-principles-1access-principles-2access-principles-3backcarrierdevelopmentease_of_administrationexportimplantableinjectablenon-implantablenon_carriernon_injectableother_featuresprintroute_of_administrationtherapeutic_areatype_of_tech

Drug information

Drug's link(s)
Generic name

Pibrentasvir

Brand names

Maviret, Mavyret (when associated with Pibrentasvir)

Compound type

Small molecule

Drug class/category

DAA

Summary

Glecaprevir and Pibrentasvir (G/P) is a fixed-dose combination therapy indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotypes 1-6 with or without compensated cirrhosis. G/P consists of two pangenotypic direct-acting antiviral agents: (1) Glecaprevir which targets the HCV non-structural viral protein 3/4A (NS3/4A) serine protease, and (2) Pibrentasvir which inhibits the HCV NS5A protein - both of which are essential for viral RNA replication and viron assembly. G/P is postulated to possess advantageous pharmacological properties - including suitable target plasma exposures, half-life duration and aqueous solubility - that could potentially enable the development of a cost-effective long-acting injectable formulation via particle-processing technologies.

Approval status

Glecaprevir and Pibrentasvir (G/P) oral fixed-dose combination is FDA approved

Regulatory authorities

Glecaprevir and Pibrentasvir (G/P) oral fixed-dose combination is FDA approved

Therapeutic area(s)

  • HCV
Use case(s)
  • Treatment

Administration route

Oral

Associated long-acting platforms

Aqueous drug particle suspension

Use of drug

Ease of administration
  • Administered by a community health worker
  • Administered by a nurse
  • Administered by a specialty health worker
  • Self-administered
Frequency of administration
  • Daily
User acceptance
Not provided

Dosage

Available dose and strength

Not provided

Maximum dose

Not provided

Recommended dosing regimen

Not provided

Additional comments

Not provided

Dosage link(s)

Not provided

Associated compounds, formulations and regimens

Associated formulations and regimens
Compare

Glecaprevir Pibrentasvir LA injection

Associated technologies

Compare
Long-Acting Injectable Solid Drug Nanoparticle (SDN) Platform

Additional information

Not provided

Developer(s)

AbbVie
Originator
United States

AbbVie

AbbVie Inc. is a global biopharmaceutical company that manufactures and develops innovative medicines as part of a diversified portfolio across several therapeutic categories including immunology, oncology, neuroscience, aesthetics and eyecare. Headquartered in North Chicago, Illinois, AbbVie was founded in 2013 following a successful corporate spin-off from its parent company Abbott Laboratories.

Drug structure

Scale-up and manufacturing prospects

Scale-up prospects

Not provided

Tentative equipment list for manufacturing

Not provided

Manufacturing

Not provided

Specific analytical instrument required for characterization of formulation

Not provided

Excipients & delivery device(s)

Proprietary excipients used

No proprietary excipient used

Novel excipients or existing excipients at a concentration above Inactive Ingredient Database (IID) for the specified route of administration

No novel excipient or existing excipient used

Residual solvents used

No residual solvent used

Delivery device(s)

No delivery device

Safety, Efficacy and Evidence Summary

Safety

Not provided

Efficacy

Not provided

Evidence Summary

Not provided

References and relevant studies

Not provided

There are either no relevant patents or these were not yet submitted to LAPaL