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Drug information

Drug's link(s)
Generic name

Glecaprevir

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, Intramuscular

Associated long-acting platforms

Aqueous drug particle suspension

Use of drug

Ease of administration
  • Administered by a nurse
  • Administered by a specialty health worker
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

Long-acting formulations of Glecaprevir and Pibrentasvir (G/P) are still in the early stages of drug development and therefore manufacturing information is limited with few reported examples. One novel approach currently being pioneered by researchers at Tandem Nano Ltd. utilises a proprietary Solid Drug Nanoparticle (SDN) technology platform to achieve high levels of G/P drug loading (>500mg/mL). Interestingly, pre-clinical pharmacokinetic assessments displayed an apparent difference in the release kinetics of both drugs which could be related to differences in aqueous solubility.

Tentative equipment list for manufacturing

Not provided

Manufacturing

Proposed minimally acceptable characteristics for prospective long-acting G/P formulations include: (1) 12-month shelf life as a powder with no cold chain required, (2) suitable drug volume enabling a one monthly intramuscular injection, (3) manageable injection site reaction, and (4) cost equal or less than the oral therapy equivalent.

Specific analytical instrument required for characterization of formulation

Not provided

Excipients & delivery device(s)

Proprietary excipients used

Not provided

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

Not provided

Residual solvents used

Not provided

Delivery device(s)

Not provided

Safety, Efficacy and Evidence Summary

Safety

Not provided

Efficacy

Not provided

Evidence Summary

Not provided

References and relevant studies

Not provided