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Pharmacokinetics of Hepcinat-Sofosbuvir


There have been carried out a few studies concerning the pharmacokinetics of Hepcinat (Sofosbuvir) and some are still in process currently - separately and together with other drugs. Hepcinat-Sofosbuvir has demonstrated a beneficial pharmacokinetic profile, as it is helpful taken orally only once day; this is mainly to improve the compliance if compared to protease inhibitors that suppose multiple oral daily doses intake, and parenteral prescription. Absorption and elimination were investigated after a single dose and multiple doses of Hepcinat/Sofosbuvir, the results were proved. The metabolic activation and process of the prodrug takes place by the enzymes function in the human liver.

The effect of hepatic impairment was thoroughly researched in a seven-day treatment course with Hepcinat-Sofosbuvir in 17 patients suffering from moderate-to-severe form of HCV-related hepatic impairment compared to 8 non-cirrhotic patients ill with HCV. There was observed no dramatic difference in the half-life period with or without hepatic impairment existence. The viral decline was less expressed. The safety profile turned to be good in all the participating patients, in such way suggesting that no dosage adjustments or temporal modification was necessary in patients with moderate-to-severe form of hepatic impairment.

The effect of renal impairment on the pharmacokinetics of Hepcinat (Sofosbuvir) has also been investigated with the usage of a single 400 mg dose, in patients with varied degrees of renal impairment. Dosage adjustment or temporal modifications are in such a way suggested in patients with moderate-to-severe form of renal impairment. Moreover, 15% of Hepcinat/Sofosbuvir has been eliminated by hemodialysis in patients with end-stage renal disease; dosage adjustment will be advised in this category of patients.

That is why; we may conclude that positive results from numerous clinical trials, plus a vivid demonstration of efficacy in patients who cannot take Interferon-based treatment and in patients with liver cancer being prepared for liver transplantation, turn this drug into a precious and very irreplaceable therapy for these patients' categories.

However, careful clinical use and testing is still important to follo. It is necessary to collect more data on this drug. Large additional studies such as pharmacoepidemiological and pharmacovigilance studies give many clear answers to many unanswered questions for the nearest future of this drug. Nowadays, Hepcinat-Sofosbuvir is among the most much-promising drugs invented for the treatment of chronic HCV infection.


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