Kailiwei Coblopasvir Hydrochloride Capsules

1. Indications and Usage
HCV Infection: Treatment of treatment-naïve or interferon-experienced adult patients with chronic genotype 1, 2, 3, or 6 HCV infection, with or without compensated cirrhosis, in combination with sofosbuvir.
2. Dosage and Administration
Route of Administration: Oral administration ONLY.
Recommended Dosage: 60 mg once daily for 12 weeks.
Combination Therapy: Must be taken concurrently with sofosbuvir (400 mg once daily) for 12 weeks.
Critical Administration Instructions:
Food Requirement: Can be taken with or without food.
Swallowing: Swallow the capsule whole; do not chew, crush, or open.
Missed Dose: If a dose is missed, take it as soon as possible on the same day. If missed on the next day, take the regular dose at the usual time; do not double the dose.
Renal/Hepatic Impairment: No dosage adjustment needed for mild renal impairment or compensated cirrhosis (Child-Pugh A). Not recommended for moderate/severe hepatic impairment.
3. Mechanism of Action
NS5A Inhibition: Coblopasvir is a non-nucleoside inhibitor of the HCV NS5A protein.
Viral Assembly Blockade: It binds to NS5A, inhibiting viral RNA assembly and the secretion of viral particles.
Selectivity: This mechanism specifically blocks HCV replication with a high genetic barrier to resistance when used in combination with sofosbuvir.
4. Safety and Warnings
HBV Reactivation: Potential risk of Hepatitis B virus (HBV) reactivation in co-infected patients. Screen for HBV status prior to treatment.
Hepatotoxicity: Risk of ALT/AST elevations. Monitor liver function tests before initiation and periodically during treatment.
Drug Interactions: Concomitant use with strong inducers of CYP3A4 and P-gp (e.g., rifampin, carbamazepine) is contraindicated due to the risk of reduced exposure and therapeutic failure.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Neutrophil count decreased (3.8%), fatigue (3.0%), hypoalbuminemia (2.7%), headache (1.9%), and hyperuricemia (1.6%).
Laboratory Abnormalities: Asymptomatic increases in ALT, AST, uric acid, and decreases in neutrophil and platelet counts.
Clinical Research Highlights: Phase 3 clinical trials demonstrated robust sustained virologic response (SVR12) rates (>95%) across various HCV genotypes in both treatment-naïve and treatment-experienced populations.
6. Drug Interactions
CYP3A4 and P-gp Modulators: Coblopasvir is a substrate of CYP3A4 and P-gp. Strong inducers significantly reduce drug exposure.
OATP1B1/3 Inhibitors: Concomitant use with OATP1B1/3 inhibitors (e.g., cyclosporine) may increase coblopasvir exposure.
Acid-Reducing Agents: Generally have minimal impact on absorption compared to other DAAs, but clinical guidance should be followed.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Coblopasvir Hydrochloride.
Appearance: Hard capsules containing white or off-white granules and powder.
Packaging: Blister packaging (e.g., 60 mg per capsule).
Storage: Store at or below 30°C in a well-closed container; protect from moisture.