voxilaprevir

Action and Spectrum

Actions and spectrum: 

Action: 

voxilaprevir is a direct-acting antiviral agent that specifically targets the HCV NS3/4A protease. By inhibiting this protease, voxilaprevir disrupts the life cycle of the hepatitis C virus, preventing it from multiplying and spreading in the body. This inhibition leads to a significant reduction in viral load, making it easier for the immune system to control and clear the HCV infection. 

Spectrum: 

voxilaprevir is effective against multiple genotypes of the hepatitis C virus, including genotypes 1, 2, 3, 4, 5, and 6. Its broad spectrum of antiviral activity makes it a valuable component in the treatment of HCV, as it can address different viral genotypes, increasing the likelihood of successful viral clearance. 

voxilaprevir is typically used in combination with other DAAs to form comprehensive treatment regimens tailored to the specific HCV genotype and individual patient characteristics. The choice of the treatment regimen is often made by a healthcare provider with expertise in the management of HCV. 

Drug Interaction

Adverse Reaction

Frequency not defined 

Diarrhoea 

Nausea 

vomiting 

Black Box Warning

Black Box Warning: 

There were no specific black box warnings associated with voxilaprevir. 

Contraindication / Caution

Contraindication/Caution: 

Contraindication: 

• Hypersensitivity: Individuals with a known hypersensitivity or allergy to voxilaprevir or any of the components of the medication should not use it. 
• Pregnancy: The safety and efficacy of voxilaprevir during pregnancy have not been well established. It should be used during pregnancy only if the potential benefits outweigh the potential risks and under the close supervision of a healthcare provider. 
• Breastfeeding: It is not clear whether voxilaprevir is excreted into human breast milk, and its effects on the nursing infant are not well studied. Healthcare providers typically evaluate the potential risks and benefits of breastfeeding while taking voxilaprevir on a case-by-case basis. 
• Pediatric Use: The safety and efficacy of voxilaprevir have not been established in pediatric patients, and its use is not recommended for individuals below a certain age. The age at which it is considered safe and effective may vary depending on regional regulatory guidelines.

Caution: 

• Concurrent Medications: voxilaprevir is often used in combination with other antiviral medications, such as sofosbuvir. Caution should be exercised when using voxilaprevir in combination with other medications, as drug-drug interactions may occur. Healthcare providers should carefully evaluate the potential for interactions and adjust treatment regimens as needed. 
• Renal Impairment: voxilaprevir is excreted in part by the kidneys, and individuals with renal impairment may require dose adjustments or closer monitoring during treatment.  
• Hepatic Impairment: While voxilaprevir is used to treat hepatitis C, its use in individuals with severe hepatic impairment or decompensated cirrhosis may require careful monitoring and dose adjustments. The presence of advanced liver disease should be assessed by a healthcare provider when considering voxilaprevir treatment. 
• Psychiatric Conditions: Some individuals with HCV infection may have coexisting mental health conditions. The use of voxilaprevir should be considered with caution in individuals with preexisting psychiatric disorders, and these conditions should be monitored and managed appropriately during treatment.

Comorbidities: 

• Liver Cirrhosis: Many individuals with chronic HCV infection develop liver cirrhosis over time. This is a significant comorbidity, as cirrhosis can lead to liver dysfunction and complications. voxilaprevir, often used in combination with other antiviral medications, is aimed at suppressing the virus and preventing further liver damage in individuals with HCV-related cirrhosis. 
• HIV Coinfection: Coinfection with human immunodeficiency virus (HIV) is common among individuals with HCV. Managing both infections can be complex, and voxilaprevir treatment may need to be coordinated with antiretroviral therapy for HIV. 
• Substance Use Disorders: Substance abuse or dependence can be comorbid with HCV infection. The treatment of substance use disorders may involve addressing both addiction and the management of HCV infection. 
• Cardiovascular Disease: Individuals with HCV may also have comorbid cardiovascular conditions. voxilaprevir treatment should be carefully coordinated with the management of cardiovascular risk factors. 

Pregnancy / Lactation

Pregnancy consideration: pregnancy category: not assigned 

Lactation: excreted into human milk: unknown  

Pregnancy category: 

• Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester. 
• Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 
• Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.   
• Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits. 
• Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women. 
• Category N: There is no data available for the drug under this category. 

Pharmacology

Pharmacology: 

voxilaprevir is a direct-acting antiviral (DAA) medication used to treat chronic hepatitis C virus infection. It specifically targets the HCV NS3/4A protease, a critical enzyme in the viral replication process. By inhibiting this protease, voxilaprevir disrupts the life cycle of the hepatitis C virus, preventing viral replication and assembly.

This action results in a significant reduction in viral load, facilitating the immune system’s ability to clear the HCV infection. voxilaprevir is often used as part of combination therapy with other DAAs, creating highly effective treatment regimens that can address various HCV genotypes. Its effectiveness and broad-spectrum antiviral activity make it a valuable component in the management of HCV infection.  

Pharmacodynamics: 

• Target Protein Inhibition: voxilaprevir targets the NS3/4A protease of the hepatitis C virus. This protease is essential for viral replication and assembly. voxilaprevir acts by inhibiting the function of NS3/4A, preventing the cleavage of viral polyproteins and the formation of new virus particles. As a result, the virus cannot replicate and propagate effectively. 
• Reduction in Viral Load: By disrupting the action of the NS3/4A protease, voxilaprevir significantly reduces the viral load within the patient’s body. Lowering the viral load is a key goal in HCV treatment, as it allows the patient’s immune system to better control and eventually clear the infection. 
• Broad-Spectrum Antiviral Activity: voxilaprevir exhibits activity against multiple genotypes of the hepatitis C virus, including genotypes 1, 2, 3, 4, 5, and 6. This broad-spectrum antiviral activity makes voxilaprevir a versatile option in the treatment of HCV, as it can be effective against various viral strains.

Pharmacokinetics: 

Absorption 

voxilaprevir is taken orally, typically in tablet form. It is absorbed from gastrointestinal tract into bloodstream after oral administration. 

Distribution 

voxilaprevir is distributed throughout the body, including the liver, where it can exert its antiviral effects against HCV. 

Metabolism 

voxilaprevir undergoes minimal hepatic metabolism. It is primarily eliminated as an unchanged drug in the feces. 

Elimination and excretion 

voxilaprevir and its metabolites are primarily excreted in the feces, with only a small portion eliminated in the urine. 

Adminstartion

Administration: 

• Dosage: The dosage of voxilaprevir is determined by the healthcare provider based on the individual’s specific condition, the HCV genotype, and their response to treatment. It is essential to follow the prescribed dosage instructions carefully. 
• Oral Administration: voxilaprevir is taken by mouth, and the tablets should be swallowed whole with a glass of water. They should not be crushed, broken, or chewed unless specifically instructed by the healthcare provider. 
• Timing: voxilaprevir is usually taken once daily, typically with food. Following the dosing schedule provided by the healthcare provider is important to maintain consistent drug levels in the bloodstream. 
• Duration: The duration of voxilaprevir treatment depends on the HCV genotype, the patient’s clinical response, and the specific treatment regimen. Treatment ranges from several weeks to several months, and it is essential to complete the full course of therapy as prescribed. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: voxilaprevir 

Pronounced: (vox-il-a-PREV-ir)  

Why do we use voxilaprevir? 

voxilaprevir is primarily used in the treatment of chronic hepatitis C virus (HCV) infection. It is part of a comprehensive antiviral treatment regimen aimed at eradicating the virus and achieving sustained virological response (SVR). voxilaprevir is used in combination with other direct-acting antiviral (DAA) medications to treat individuals with chronic HCV infection. Its primary purpose is to suppress viral replication, reduce the viral load, and clear the virus from the patient’s body.