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What treatment does Hepcvir L treat?
- Hepcvir-L is used to treat chronic hepatitis C virus genotype 1 in adults. Hepcvir-L is an antiviral drug containing 2 active ingredients: 90mg ledipasvir and 400mg sofosbuvir.
- Ledipasvir, HCV NS5A and sofosbuvir protein inhibitors, HCV NS5B-dependent RNA polymerase inhibitors, work together to prevent transcription of the HCV viral genotype.
Some notes about patients needing attention
- Population pharmacokinetic analyzes of HCV-infected subjects indicate that gender has no clinical effect on sofosbuvir and GS-331007 exposures. The AUC and C max of ledipasvir were 77% and 58% higher, respectively, for women than men.
- However, the relationship between sex exposure and ledipasvir is not considered clinically relevant, since a high response rate (SVR> 90%) has been achieved in men and women in the studies. Phase 3 studies and safety profiles are similar in women and men.
For children - The pharmacokinetics of ledipasvir or sofosbuvir in pediatric patients has not been established.
For older people - Population pharmacokinetic analyzes of HCV-infected subjects showed that in the age group (18 to 80 years) analyzed, the age had no clinical effect on exposure to ledipasvir, sofosbuvir and GS-331007.
For patients with renal insufficiency
- The pharmacokinetics of ledipasvir was studied in a single dose of 90 mg of ledipasvir in HCV-negative subjects with severe renal impairment (estimated glomerular filtration rate <30 ml / min by Cockcroft-Gault).
- No clinically relevant differences in ledipasvir pharmacokinetics were observed between healthy subjects and subjects with severe renal impairment.
- The pharmacokinetics of sofosbuvir has been studied in HCV negative subjects in mild (eGFR≥50 and <80 ml / min / 1.73 m 2), medium (eGFR ≥30 and <50 mL / min / 1.73 m 2); Severe renal insufficiency (eGFR <30 mL / min / 1.73 m2) and subjects with end-stage renal disease (ESRD) require hemodialysis after a single 400 mg sofosbuvir dose. Relates to subjects with normal renal function (eGFR> 80 mL / minute / 1.73 m2); sofosbuvir AUC 0-inf is 61%, 107% and 171% higher in people with mild, moderate and severe renal impairment, while GS-331007 AUC 0-inf is 55%, 88% and 451% higher, respectively.
- In subjects with ESRD, with regard to subjects with normal renal function, sofosbuvir and GS-331007 AUC0-inf were 28% higher and 1,280% when sofosbuvir was administered 1 hour before hemodialysis compared to 60% and 2.070% higher when sofosbuvir is administered 1 hour after hemodialysis. A 4-hour dialysis session removes approximately 18% of the dose.
For patients with hepatic impairment
- The pharmacokinetics of ledipasvir was studied with a single dose of 90 mg of ledipasvir in subjects negative for HCV with severe hepatic impairment (Child-Pugh Class C). Ledipasvir (AUC 0-inf) plasma exposure was similar in subjects with severe hepatic impairment and control subjects with normal liver function.
- Population pharmacokinetic analyzes of HCV-infected subjects indicate that cirrhosis has no clinical effect on ledipasvir exposure.
- The pharmacokinetics of sofosbuvir was studied after 7 days of using 400 mg of sofosbuvir in subjects infected with HCV with moderate and severe hepatic impairment (Children B and C). Regarding subjects with normal liver function, sofosbuvir AUC 0-24 is 126% higher and 143% higher in moderate and severe hepatic impairment, while GS-331007 AUC 0-24 is 18% higher and respectively 9%.
- Population pharmacokinetic analysis of HCV-infected subjects indicates that cirrhosis has no clinical effect on sofosbuvir and GS-331007 exposures.
What are the interactions with Hepcvir L?
- Sofosbuvir is the substrate of the P-gp drug transporter and breast cancer protein (BCRP) while the circulating metabolite predominates GS-331007 does not. P-gp inducers in the intestine (for example, rifampin or St. John's wort) may decrease the sofosbuvir plasma concentration, resulting in reduced therapeutic effects of SOVALDI, and therefore should not be used. Simultaneous use with SOVALDI.
- Clearance of HCV infection with direct antiviral drugs may lead to changes in liver function, which may affect the safe and effective use of the drug. For example, altered glycemic control resulting in severe symptomatic hypoglycemia has been reported in diabetics in published case reports and epidemiological studies. Hypoglycemic management in these cases requires stopping or adjusting the dose of the drug and is also used to treat diabetes.
- Regular monitoring of relevant laboratory parameters (e.g., international normalization rate [INR] in patients on warfarin, blood glucose levels in diabetics), or drugs of concomitant drugs such as cytochrome P450 substrates with a narrow therapeutic index (eg, certain immunosuppressive drugs) ensure safe and effective use. Simultaneous dose adjustment of the drug may be necessary.
See more general knowledge information
- Thuoc hepcvir L dieu tri viem gan C – Gia thuoc hepcvir L https://nhathuocgan.com/thuoc-hepcvir-l-dieu-tri-viem-gan-c/
- Thuoc Hepcvir L dong thuoc dieu tri viem gan C hieu qua https://dieutriung.org/thuoc-hepcvir-l-dieu-tri-viem-gan-c/
- Thuoc Hepcvir L hoat chat Ledipasvir 90mg Sofosbuvir 400mg https://nhathuocgan.blogspot.com/2019/12/thuoc-hepcvir-l-hoat-chat-ledipasvir-sofosbuvir.html
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