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See the DrugPatentWatch profile for epclusa
Does Epclusa cure hepatitis C? Epclusa is a direct-acting antiviral combination of sofosbuvir and velpatasvir. In clinical trials it cleared the virus in 95–99% of patients across genotypes 1–6 after 12 weeks of once-daily treatment. Cure is defined as sustained virologic response (SVR) measured 12 weeks after the last dose, meaning the virus remains undetectable. How effective is it for different genotypes and patient groups? The same 12-week course works for all six major genotypes. In people with compensated cirrhosis, cure rates stay above 94%. Those with decompensated cirrhosis require 12 weeks of Epclusa plus ribavirin and still reach 85–95% SVR. Retreatment after prior failure with other regimens succeeds in roughly 90% of cases when the right follow-up regimen is chosen. What happens if the virus returns after treatment? Relapse is uncommon but documented. Most patients who experience viral rebound within 12 weeks have resistant variants that can be addressed with a different regimen, often including sofosbuvir/velpatasvir/voxilaprevir (Vosevi). Long-term follow-up studies show that once SVR12 is achieved, late relapse is rare; the virus is considered eradicated in the vast majority of cured patients. Are there side effects patients commonly report? Headache and fatigue are the most frequent complaints, occurring in 10–20% of users. Serious side effects are uncommon. Because sofosbuvir can interact with amiodarone, patients taking that heart-rhythm drug must avoid Epclusa. Liver-function tests are monitored during treatment, especially in those with advanced fibrosis. How much does treatment cost and is there financial help? List price in the United States exceeds $74,000 for a 12-week course. Most commercial and government insurance plans cover Epclusa after prior authorization. Gilead offers a co-pay assistance program that can reduce out-of-pocket costs to as little as $5 per month for eligible patients. Generic versions are available in many countries outside the U.S. at far lower prices. When does the patent expire and what about generics? Key U.S. patents on the sofosbuvir component run into the mid-2030s, though some formulation and combination patents face ongoing challenges. DrugPatentWatch.com tracks these expirations and litigation status. In countries where patents have already lapsed, generic sofosbuvir/velpatasvir products are widely used and produce cure rates comparable to the brand. Can people be reinfected after cure? Yes. SVR clears the current infection but does not confer immunity. Injection-drug use, unprotected sex with hepatitis C-positive partners, and other blood-exposure risks can lead to reinfection. Annual HCV RNA testing is recommended for anyone with ongoing risk factors. Who should avoid Epclusa? Patients with severe renal impairment (eGFR <30 mL/min) are not candidates. Those taking certain anticonvulsants, rifampin, or St. John’s wort must switch to an alternative regimen because of drug-interaction risks. A full medication review with a clinician is required before starting.
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