velpatasvir

Action and Spectrum

Actions and spectrum: 

Action: 

velpatasvir is a direct-acting antiviral agent (DAA) that specifically targets the hepatitis C virus. It acts as an inhibitor of NS5A protein, which is essential for replication and assembly. By blocking the action of NS5A, velpatasvir interferes with life cycle of 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 infection. 

Spectrum: 

velpatasvir is primarily used as part of a combination therapy with other DAAs, such as sofosbuvir, to treat chronic hepatitis C virus infection. It is effective against multiple genotypes of the hepatitis C virus, including genotypes 1, 2, 3, 4, 5, and 6. The broad spectrum of velpatasvir’s antiviral activity makes it a valuable component in the treatment of hepatitis C, as it can address different viral genotypes, increasing the likelihood of successful viral clearance. 

Drug Interaction

Adverse Reaction

Frequency not defined 

Headache 

Cough 

Hypertension 

Nausea 

Black Box Warning

Black Box Warning: 

there were no specific black box warnings associated with velpatasvir. 

Contraindication / Caution

Contraindication/Caution: 

Contraindication: 

• Hypersensitivity: Individuals with a known hypersensitivity or allergy to velpatasvir or any of the components of the medication should not use it. 
• Medication Combinations: velpatasvir is often used in combination with other antiviral medications, such as sofosbuvir. The use of velpatasvir may be contraindicated with specific medication combinations. 
• Pregnancy and Lactation: The safety & efficacy of velpatasvir during pregnancy and breastfeeding 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. 
• Concurrent Medications: velpatasvir is often used in combination with other antiviral medications, such as sofosbuvir. Caution should be exercised when using velpatasvir 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

Caution: 

• Renal Impairment: velpatasvir is excreted in part by the kidneys, and individuals with renal impairment may require dose adjustments or closer monitoring during treatment.  
• Hepatic Impairment: While velpatasvir 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. 
• Pediatric Use: velpatasvir’s safety and effectiveness 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. 
• Psychiatric Health: Some individuals with HCV infection may have coexisting mental health conditions. The use of velpatasvir 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. velpatasvir, 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 velpatasvir 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. velpatasvir 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: 

velpatasvir is a direct-acting antiviral (DAA) medication used to treat chronic hepatitis C virus infection. It exerts its antiviral effects by targeting the HCV NS5A protein, which is crucial for viral replication. By inhibiting NS5A, velpatasvir disrupts the HCV life cycle, preventing viral replication and assembly. This action leads to a substantial reduction in viral load and promotes the clearance of the virus from the body.

velpatasvir is commonly used in combination with other DAAs to create effective treatment regimens tailored to the specific HCV genotype and individual patient characteristics. Its ability to treat multiple HCV genotypes makes it a valuable component in the management of HCV infection, offering a potential cure for many individuals with this viral condition.  

Pharmacodynamics: 

velpatasvir, a potent direct-acting antiviral (DAA), operates by selectively inhibiting the replication of the hepatitis C virus (HCV). Its pharmacodynamics involve targeting the non-structural protein 5A (NS5A), a vital component in the HCV replication process. By inhibiting the action of NS5A, velpatasvir interferes with the assembly and replication of the virus within infected cells.

This disruption significantly reduces the production of new viral particles and hinders the spread of the virus in the body. The inhibition of NS5A leads to a substantial decrease in viral load, facilitating the body’s immune response to clear the HCV infection. velpatasvir’s potent and specific action against the virus contributes to its efficacy in treating chronic HCV infection, especially when used in combination with other antiviral agents.  

Pharmacokinetics: 

Absorption 

velpatasvir is taken orally, usually in the form of a tablet. It is absorbed from gastrointestinal tract into the bloodstream after oral administration. 

Distribution 

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

Metabolism 

velpatasvir undergoes minimal hepatic metabolism. It is primarily excreted in the feces. 

Elimination and excretion 

velpatasvir and its metabolites are primarily excreted in the feces, with only a small portion eliminated in the urine. The elimination half-life of velpatasvir is long, allowing for once-daily dosing. 

Adminstartion

Administration: 

• Dosage: The dosage of velpatasvir 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: velpatasvir 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: velpatasvir 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 velpatasvir treatment depends on the HCV genotype, the patient’s clinical response, and the specific treatment regimen. Treatment can range from weeks to months, and it is essential to complete the full course of therapy as prescribed. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: velpatasvir 

Pronounced: (vel-PAT-a-sveer)  

Why do we use velpatasvir? 

velpatasvir is utilized as part of combination therapy to treat individuals with chronic HCV infection. It is often used in conjunction with other direct-acting antiviral (DAA) medications, such as sofosbuvir. The combination therapy is tailored to the specific HCV genotype and the patient’s clinical profile. 

The goal of velpatasvir treatment is to achieve sustained virological response (SVR), which indicates that the virus is no longer detectable in the blood. SVR is often considered a functional cure for HCV, reducing the risk of liver cirrhosis, hepatocellular carcinoma, and other HCV-related complications.