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General Description:

Voxilaprevir, identified by CAS number 1535212-07-7, is a notable compound with significant therapeutic applications. Voxilaprevir is a Direct-Acting Antiviral (DAA) medication used as part of combination therapy to treat chronic Hepatitis C, an infectious liver disease caused by infection with Hepatitis C Virus (HCV). HCV is a single-stranded RNA virus that is categorized into nine distinct genotypes, with genotype 1 being the most common in the United States, and affecting 72% of all chronic HCV patients . Voxilaprevir exerts its antiviral action by reversibly binding and inhibiting the NS3/4A serine protease of Hepatitis C Virus (HCV) . Following viral replication of HCV genetic material and translation into a single polypeptide, Nonstructural Protein 3 (NS3) and its activating cofactor Nonstructural Protein 4A (NS4A) are responsible for cleaving genetic material into the following structural and nonstructural proteins required for assembly into mature virus: NS3, NS4A, NS4B, NS5A, and NS5B . By inhibiting viral protease NS3/4A, voxilaprevir therefore prevents viral replication and function. Treatment options for chronic Hepatitis C have advanced significantly since 2011, with the development of Direct Acting Antivirals (DAAs) such as voxilaprevir. Voxilaprevir has been available since July 2017 in a fixed dose combination product with and as the commercially available product Vosevi. Vosevi is approved for the treatment of adult patients with chronic HCV infection with genotype 1, 2, 3, 4, 5, or 6 infection . Notably, Vosevi is approved for use in patients with genotypes 1-6 who have been previously treated with an NS5A inhibitor, or patients with genotypes 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor . Prior to Vosevi, there were no approved retreatment options for patients who have previously received, and failed, a regimen containing an NS5A inhibitor for treatment of chronic HCV infection.

Indications:

This drug is primarily indicated for: Vosevi (Voxilaprevir//) is approved for use in patients with genotypes 1-6 who have been previously treated with an NS5A inhibitor, or patients with genotypes 1a or 3 infection who have previously been treated with an HCV regimen containing without an NS5A inhibitor . Its use in specific medical scenarios underscores its importance in the therapeutic landscape.

Metabolism:

Voxilaprevir undergoes metabolic processing primarily in: Voxilaprevir is primarily metabolized by Cytochrome P450 3A4 (CYP3A4) and to a lesser extent by CYP2C8 and CYP1A2. This metabolic pathway ensures efficient processing of the drug, helping to minimize potential toxicity and side effects.

Absorption:

The absorption characteristics of Voxilaprevir are crucial for its therapeutic efficacy: When provided as the fixed dose combination product Vosevi with and , voxilaprevir reaches a maximum concentration (Cmax) of 192 ng/mL at a maximum time (Tmax) of 4 hours post-dose . The drug's ability to rapidly penetrate into cells ensures quick onset of action.

Half-life:

The half-life of Voxilaprevir is an important consideration for its dosing schedule: 33 hr. This determines the duration of action and helps in formulating effective dosing regimens.

Protein Binding:

Voxilaprevir exhibits a strong affinity for binding with plasma proteins: Voxilaprevir is more than 99% bound to human plasma proteins . This property plays a key role in the drug's pharmacokinetics and distribution within the body.

Route of Elimination:

The elimination of Voxilaprevir from the body primarily occurs through: Voxilaprevir is primarily eliminated via biliary excretion . Understanding this pathway is essential for assessing potential drug accumulation and toxicity risks.

Pharmacodynamics:

Voxilaprevir exerts its therapeutic effects through: Voxilaprevir is a direct-acting antiviral agent that targets viral NS3/4A protein and causes a decrease in serum HCV RNA levels. It disrupts HCV replication by specifically inhibiting the critical functions of NS3/4A protein in the replication complex. It does not appear to prolong the QT interval even when given at 9 times the maximum recommended dose . The drug's ability to modulate various physiological processes underscores its efficacy in treating specific conditions.

Mechanism of Action:

Voxilaprevir functions by: Voxilaprevir exerts its antiviral action by reversibley binding and inhibiting the NS3/4A serine protease of Hepatitis C Virus (HCV) . Following viral replication of HCV genetic material and translation into a single polypeptide, Nonstructural Protein 3 (NS3) and its activating cofactor Nonstructural Protein 4A (NS4A) are responsible for cleaving genetic material into the following structural and nonstructural proteins required for assembly into mature virus: NS3, NS4A, NS4B, NS5A, and NS5B . By inhibiting viral protease NS3/4A, voxilaprevir therefore prevents viral replication and function. This mechanism highlights the drug's role in inhibiting or promoting specific biological pathways, contributing to its therapeutic effects.

Classification:

Voxilaprevir belongs to the class of organic compounds known as cyclic peptides. These are compounds containing a cyclic moiety bearing a peptide backbone, classified under the direct parent group Cyclic peptides. This compound is a part of the Organic compounds, falling under the Organic acids and derivatives superclass, and categorized within the Carboxylic acids and derivatives class, specifically within the Amino acids, peptides, and analogues subclass.

Categories:

Voxilaprevir is categorized under the following therapeutic classes: Acids, Acyclic, Amides, Amino Acids, Amino Acids, Branched-Chain, Amino Acids, Cyclic, Amino Acids, Essential, Amino Acids, Peptides, and Proteins, Aminobutyrates, Antiinfectives for Systemic Use, Antiviral Agents, Antivirals for Systemic Use, Antivirals for treatment of HCV infections, BCRP/ABCG2 Inhibitors, BCRP/ABCG2 Substrates, Butyrates, Cycloparaffins, Cytochrome P-450 CYP1A2 Substrates, Cytochrome P-450 CYP2C8 Substrates, Cytochrome P-450 CYP3A Substrates, Cytochrome P-450 CYP3A4 Substrates, Cytochrome P-450 Substrates, Direct Acting Antivirals, HCV NS3/4A Protease Inhibitors, Heterocyclic Compounds, Fused-Ring, Imino Acids, Isobutyrates, Lactams, NS3/4A Protease Inhibitors, OATP1B1/SLCO1B1 Inhibitors, OATP1B1/SLCO1B1 Substrates, OATP1B3 inhibitors, OATP1B3 substrates, Organic Anion Transporting Polypeptide 1B1 Inhibitors, Organic Anion Transporting Polypeptide 1B3 Inhibitors, P-glycoprotein inhibitors, P-glycoprotein substrates, Sulfones, Sulfur Compounds, Treatments for Hepatitis C. These classifications highlight the drug's diverse therapeutic applications and its importance in treating various conditions.