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Panovir 400mg+100mg | 1 Strip
Sofosbuvir + Velpatasvir
This fixed-dose antiviral combination is prescribed for adults and children aged 3 years and above diagnosed with chronic Hepatitis C Virus (HCV) infection, regardless of genotype (1 through 6), in the following patient populations:
- Without cirrhosis or with compensated cirrhosis (Child-Pugh A)
- With decompensated cirrhosis (Child-Pugh B or C) in combination with ribavirin
Hepatitis B reactivation can occur during or after therapy. Test all patients for HBV markers prior to treatment. Monitor and manage HBV-positive patients carefully.
Use with caution; hospitalization and close ECG monitoring may be needed.
All ribavirin-related warnings apply when used with Sofosbuvir/Velpatasvir.
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✅ Description:
Sofosbuvir: A nucleotide analog prodrug that targets NS5B RNA-dependent RNA polymerase, critical for viral RNA replication. It’s converted intracellularly to GS-461203 (triphosphate form), which halts viral replication by acting as a chain terminator.
Velpatasvir: A direct-acting antiviral agent that inhibits the NS5A protein, which is essential for HCV RNA replication and virion assembly.
This dual action targets different stages of the viral life cycle, making the combination broadly effective across HCV genotypes.
Cardiac Safety: Neither Sofosbuvir (up to 3x the recommended dose) nor Velpatasvir (up to 5x the recommended dose) significantly prolong the QT interval, based on thorough QT studies.
✔️ Side Effects
Common Adverse Reactions:
Fatigue, headache, nausea, insomnia, diarrhea, anemia, itching, muscle cramps, cough, and breathlessness
Less Common but Notable:
Reductions in hemoglobin, lymphocyte, neutrophil, and platelet counts.
Bradycardia (notably with amiodarone coadministration)
✔️ Dosage & Administration
Pre-Treatment Testing:
Screen all patients for current or past Hepatitis B infection (HBsAg and anti-HBc) before starting treatment.
Adults:
Usual dose: One tablet (Sofosbuvir 400 mg + Velpatasvir 100 mg) taken once daily, with or without food.
In decompensated cirrhosis, add ribavirin:
<75 kg: 1,000 mg/day (divided BID)
≥75 kg: 1,200 mg/day (divided BID)
Pediatrics (3 years and older):
Dose is based on body weight; refer to specific pediatric dosing tables.
Use in Special PopulationsElderly (≥65 years): No clinically significant changes in drug exposure. Renal Impairment: Mild to moderate: No dose adjustment needed. Severe or ESRD: Increased metabolite accumulation; caution advised. Hepatic Impairment: Mild to severe (including decompensated): No dose adjustment necessary; exposure increases are not clinically relevant. |
✔️ Overdose Management
No antidote. If overdose occurs:
- Monitor for toxicity
- Provide supportive care
- Hemodialysis may help remove Sofosbuvir metabolite (GS-331007), but not Velpatasvir due to high protein binding.
✔️ Drug Interactions
Drugs That Decrease Efficacy:
CYP3A4/P-gp inducers (e.g., Rifampin, St. John’s Wort, Carbamazepine) can lower plasma levels of both components—avoid concurrent use.
Sofosbuvir/Velpatasvir as Inhibitors:
Velpatasvir inhibits P-gp, BCRP, and OATP transporters. Caution is needed when coadministering drugs that depend on these transporters, as it may increase their plasma concentration.
Serious Interaction:
Coadministration with Amiodarone may lead to life-threatening symptomatic bradycardia. Avoid use if possible. If necessary, inpatient cardiac monitoring is advised during the initial 48 hours and outpatient heart rate monitoring for 2 weeks.
✔️ Contraindications:
Any contraindications to Ribavirin also apply when used in combination. Refer to ribavirin’s product details.
✔️ Use in Pregnancy & Lactation
Pregnancy: If coadministered with ribavirin, contraindicated in pregnant women and in men with pregnant partners due to teratogenic risks.
Breastfeeding: Unknown if drug components are excreted in human milk; caution advised.
Reproductive Potential: When combined with ribavirin, pregnancy testing and contraception are mandatory. Refer to ribavirin guidelines.
✔️ Storage Conditions
Store in a cool, dry place (preferably below 30°C), away from light and moisture.
Keep out of reach of children
⚠️Disclaimer:
At ePharma, we’re committed to providing accurate and accessible health information. However, all content is intended for informational purposes only and should not replace medical advice from a qualified physician. Please consult your healthcare provider for personalized guidance. We aim to support, not substitute, the doctor-patient relationship.
