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November 16, 2025
Brand Name :
harvoni
Synonyms :
ledipasvir/sofosbuvir
Class :
Hepatitis C virus polymerase inhibitors
Brand Name :
harvoni
Synonyms :
ledipasvir/sofosbuvir
Class :
Hepatitis C virus polymerase inhibitors
Dosage Forms & StrengthsÂ
TabletÂ
45mg/200mgÂ
90mg/400mgÂ
<3 years: Safety and efficacy not established
>3 years:
<17kgs: 1 tablet (33.75mg/150mg) of pellets orally every day
17 to <35kg: 1 tablet (45mg/200mg) of pellets orally every day
>35kgs:1 tablet(90mg/400mg) orally everyday or 2 tablet(45mg/200mg) orally everyday
may enhance the serum concentration of P-glycoprotein/ABCB1 Inhibitors
may increase the bradycardic effect
may diminish the serum concentration
may diminish the serum concentration
may diminish the serum concentration
may diminish the serum concentration
may diminish the serum concentration
may enhance the serum concentration
may enhance the serum concentration
may decrease the serum concentration
may decrease the serum concentration
may decrease the serum concentration
may decrease the serum concentration
may decrease the serum concentration
may decrease the serum concentration
may decrease the serum concentration
may enhance the serum concentration
may enhance the serum concentration
may enhance the serum concentration
may enhance the serum concentration
may enhance the serum concentration
may enhance the serum concentration
may decrease the serum concentration
may diminish the serum concentration
may enhance the serum concentration
may enhance the serum concentration
may enhance the serum concentration
may enhance the serum concentration
may enhance the serum concentration
may enhance the serum concentration
may enhance the serum concentration
may enhance the serum concentration
Frequency defined:Â Â
>10%Â
FatigueÂ
CoughÂ
AstheniaÂ
HeadacheÂ
1-10%Â
DiarrheaÂ
DyspnoeaÂ
Increased bilirubin >1.5 X ULNÂ
MyalgiaÂ
NauseaÂ
DizzinessÂ
InsomniaÂ
Increased lipase >3 X ULNÂ
IrritabilityÂ
Post-marketing reportsÂ
Skin rashÂ
BradycardiaÂ
Pregnancy consideration: Insufficient data availableÂ
Lactation: Excretion of the drug in human breast milk is unknown Â
Pregnancy category:Â
Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.  Â
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.Â
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.   Â
Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.   Â
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.   Â
Category N: There is no data available for the drug under this categoryÂ
Patient information leafletÂ
Generic Name:Â ledipasvir/sofosbuvirÂ
Pronounced: [ le-DIP-as-vir-and-soe-FOS-bue-vir ]Â
Why do we use ledipasvir/sofosbuvir?Â
It is used to treat hepatitis C in adultsÂ