Tab Voihep

# Tab voihep (Assumed to be Vosevi: Sofosbuvir/Velpatasvir/Voxilaprevir) ## Overview - **Classification**: Direct-Acting Antiviral (DAA) combination for Hepatitis C Virus (HCV) - **Mechanism**: Inhibits HCV NS5B polymerase (sofosbuvir), NS5A protein (velpatasvir), and NS3/4A protease (voxilaprevir), blocking viral replication at multiple stages. ## Primary Indications 1. **Chronic Hepatitis C (HCV) Infection** - In adults and pediatric patients ≥ 6 years and weighing ≥ 17 kg, previously treated with a DAA-containing regimen. 2. **Chronic Hepatitis C (HCV) Infection** - Without prior DAA treatment, but with specific genotypes and/or compensated cirrhosis, where other DAA options are unsuitable or failed (less common initial use). ## Adult Dosing ### Standard Dosing **Chronic Hepatitis C (HCV) - DAA-experienced patients** - **Dose**: **1 tablet** (containing **400 mg sofosbuvir, 100 mg velpatasvir, 100 mg voxilaprevir**) - **Frequency**: Once daily - **Route**: Oral - **Duration**: **12 weeks** - **Special Considerations**: Take with food. ### Dose Adjustments - **Renal Impairment**: - CrCl > 30 mL/min: No dose adjustment needed. - CrCl ≤ 30 mL/min or End-Stage Renal Disease (ESRD) requiring dialysis: Not recommended due to higher voxilaprevir exposure. - **Hepatic Impairment**: - Child-Pugh A or B (compensated/decompensated): No dose adjustment needed. - Child-Pugh C (severe decompensated): Not recommended due to higher exposure and safety concerns. - **Elderly Patients**: No dose adjustment specific to age. Monitor for general tolerability. ## Pediatric Dosing ### Neonates (0-28 days) - **Not recommended**: Safety and efficacy not established. ### Infants (1-12 months) - **Not recommended**: Safety and efficacy not established. ### Children (1-5 years) - **Not recommended**: Safety and efficacy not established. ### Children (6-12 years) - **Indication**: Chronic Hepatitis C (HCV) - DAA-experienced patients - **Dose**: - **Weight 17 kg to < 30 kg**: **1 tablet (200 mg sofosbuvir, 50 mg velpatasvir, 50 mg voxilaprevir)** - **Weight ≥ 30 kg**: **1 tablet (400 mg sofosbuvir, 100 mg velpatasvir, 100 mg voxilaprevir)** - **Frequency**: Once daily - **Route**: Oral - **Duration**: **12 weeks** - **Special Notes**: Take with food. Specific pediatric tablet strengths are available. ### Adolescents (13-18 years) - **Indication**: Chronic Hepatitis C (HCV) - DAA-experienced patients - **Dose**: **1 tablet** (containing **400 mg sofosbuvir, 100 mg velpatasvir, 100 mg voxilaprevir**) - **Frequency**: Once daily - **Route**: Oral - **Duration**: **12 weeks** - **Maximum**: Adult dose. Take with food. ## Safety Information ### Contraindications - **Absolute**: Co-administration with strong P-gp and/or CYP inducers (e.g., rifampin, St. John's Wort, carbamazepine, phenytoin, phenobarbital). - **Absolute**: Known hypersensitivity to any component of the formulation. ### Common Adverse Effects - **Very Common (>10%)**: Headache, Diarrhea, Nausea - **Common (1-10%)**: Fatigue, Asthenia, Vomiting, Insomnia, Dizziness - **Serious but Rare**: Bradycardia when co-administered with amiodarone (especially with beta-blockers or other cardiac agents). ### Key Drug Interactions - **Amiodarone**: Risk of severe symptomatic bradycardia. Co-administration generally **contraindicated**. - **Statins (e.g., Rosuvastatin, Atorvastatin)**: Increased statin exposure. Reduce statin dose or switch to alternative. - **Acid-reducing agents (PPIs, H2RAs, Antacids)**: May decrease velpatasvir absorption. Avoid PPIs. Separate H2RAs by 12 hours, antacids by 4 hours. - **P-gp/CYP inducers (e.g., Rifampin, Carbamazepine, St. John's Wort)**: Significant decrease in DAA levels, leading to treatment failure. **Contraindicated**. - **HIV Antivirals**: Potential for complex interactions. Consult product labeling and HIV guidelines. ## Monitoring & Follow-up - **Before Treatment**: HCV RNA quantitative test, Genotype/Subtype, Liver function tests (ALT, AST, bilirubin), Renal function (CrCl), Baseline INR, CBC. Screen for Hepatitis B virus (HBV) coinfection. - **During Treatment**: Monitor for adverse effects. No routine lab monitoring is generally required during treatment. - **Clinical Signs**: Watch for signs of bradycardia (lightheadedness, fainting) if amiodarone is used. Monitor for signs of worsening liver function. - **Post-treatment**: Sustained Virologic Response (SVR) at 12 weeks post-treatment (HCV RNA quantitative test). ## Clinical Pearls - 💡 **Timing**: Always take Vosevi with food to optimize absorption. - 💡 **Prior DAA Failure**: Vosevi is specifically designed for patients who have previously failed a DAA regimen, offering a salvage option. - 💡 **Drug Interaction Counseling**: Emphasize the critical importance of disclosing ALL medications, including OTC, herbal, and supplements, due to significant drug interactions. - 💡 **Amiodarone Warning**: Reiterate the severe bradycardia risk with amiodarone; patients should report any slow heartbeat symptoms immediately. > **⚠️ Important**: This information is for educational purposes only. Always consult current prescribing information, local guidelines, and clinical judgment before prescribing.