Dasabuvir, sold under the brand name Exviera, is an antiviral medication for the treatment of hepatitis C. It is a non-nucleoside inhibitor of the hepatitis C virus NS5B RNA-dependent RNA polymerase and is indicated primarily for genotype 1 infection. Dasabuvir is administered orally and is used as part of combination regimens, most commonly together with the fixed-dose combination ombitasvir/paritaprevir/ritonavir; ribavirin may be added for selected patients based on viral subtype, presence of cirrhosis, or prior treatment history. Pharmacokinetic characteristics relevant to clinical use include primary metabolism via CYP2C8 with minor CYP3A contribution, low to moderate plasma protein binding, and predominantly hepatic elimination, which guides drug interaction screening and dose adjustment considerations.
Parent: Dasabuvir
Parent: Dasabuvir
Parent: Dasabuvir
Parent: Dasabuvir
Control of related substances for dasabuvir covers process-related impurities, oxidative and hydrolytic degradation products, and stereoisomeric or positional variants; identification and qualification follow ICH Q3A/B principles. Typical release specifications applied in development and quality control set individual specified impurities commonly in the range 0.10 to 0.30 percent w/w, with unspecified impurities monitored at reporting thresholds around 0.05 percent w/w. Total impurities are frequently limited to not more than 1.0 percent w/w, with tighter individual limits imposed when impurity characterization indicates potential toxicity or genotoxic risk. Analytical control is performed by validated high performance liquid chromatography with orthogonal confirmation by mass spectrometry and forced-degradation studies to define degradation pathways.
Dasabuvir is a non-nucleoside NS5B RNA-dependent RNA polymerase inhibitor used as a direct-acting antiviral against hepatitis C virus.
Dasabuvir is given orally as part of combination regimens; dosing and duration depend on viral genotype, presence of cirrhosis, prior treatment history, and whether ribavirin is coadministered.
Dasabuvir is commonly used with ombitasvir/paritaprevir/ritonavir and may be coadministered with ribavirin when recommended by treatment guidelines for specific patient subgroups.
Dasabuvir is primarily metabolized by CYP2C8 with minor CYP3A involvement, so inhibitors or inducers of these enzymes can alter exposure; concomitant medication review is required to avoid clinically significant interactions.
Monitored impurities include synthetic process residuals, oxidative products, hydrolysis fragments, and isomeric variants. Individual specified impurity limits are commonly set in the 0.10 to 0.30 percent w/w range, unspecified impurities at reporting thresholds near 0.05 percent w/w, and total impurities often capped around 1.0 percent w/w, with tighter limits applied as needed.
