Anthropometric Measurements as Predictors of Low Birth Weight Among Tanzanian Neonates: A Hospital-Based Study
November 7, 2025
Brand Name :
Olysio
Synonyms :
simeprevir
Class :
HCV Protease Inhibitors, Hepatitis B/Hepatitis C agents
Dosage Forms & StrengthsÂ
CapsuleÂ
150mgÂ
Suggested Treatment Regimen and Duration:
Patients with HCV genotype one infection who have had no or little therapy:
simeprevir along with sofosbuvir for 12 weeks in the absence of cirrhosis
simeprevir and sofosbuvir for 24 weeks if you have compensated cirrhosis (Child-Pugh A)
Note: For more than a year, Olysio pills have been withdrawn in the United States
Safety and efficacy not establishedÂ
Refer adult dosingÂ
may enhance the serum concentration of BCRP/ABCG2 inhibitors
may enhance the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) inhibitors
may enhance the serum concentration of simeprevir
may enhance the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors
may enhance the serum concentration of BCRP/ABCG2 inhibitors
may enhance the serum concentration of P-glycoprotein/ABCB1 inhibitors
may enhance the serum concentration of P-glycoprotein/ABCB1 inhibitors
may enhance the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors
may enhance the serum concentration of CYP3A4 inhibitors
may enhance the serum concentration of P-glycoprotein/ABCB1 inhibitors
may enhance the serum concentration of simeprevir
may enhance the serum concentration of P-glycoprotein/ABCB1 inhibitors
may enhance the serum concentration of CYP1A2 inhibitors
may enhance the serum concentration of P-glycoprotein/ABCB1 inhibitors
simeprevir: it may enhance the serum concentration of simvastatin
may increase the photosensitizing effect of photosensitizing agents
may enhance the serum concentration of P-glycoprotein/ABCB1 inhibitors
may enhance the serum concentration of simeprevir
may enhance the serum concentration of simeprevir
may enhance the serum concentration of simeprevir
may enhance the serum concentration of simeprevir
may enhance the serum concentration of simeprevir
may enhance the serum concentration of simeprevir
may enhance the serum concentration of P-glycoprotein/ABCB1 inhibitors
may enhance the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors
may enhance the serum concentration of simeprevir
may enhance the serum concentration of CYP3A4 inhibitors
may enhance the serum concentration of CYP3A4 inhibitors
may enhance the serum concentration of simeprevir
may enhance the serum concentration of simeprevir
may enhance the serum concentration of simeprevir
may enhance the serum concentration of P-glycoprotein/ABCB1 inhibitors
may enhance the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors
may enhance the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors
may enhance the serum concentration of P-glycoprotein/ABCB1 inhibitors
may enhance the serum concentration of P-glycoprotein/ABCB1 inhibitors
simeprevir: they may enhance the serum concentration of CYP3A Inhibitors
simeprevir: they may enhance the serum concentration of CYP3A Inhibitors
simeprevir: they may enhance the serum concentration of CYP3A Inhibitors
simeprevir: they may enhance the serum concentration of CYP3A Inhibitors
simeprevir: they may enhance the serum concentration of CYP3A Inhibitors
CYP3A4 inhibitors increase the concentration of simeprevir in serum
may enhance the serum concentration
protease inhibitors may reduce the level of serum concentration of hormonal contraceptives
protease inhibitors may reduce the level of serum concentration of hormonal contraceptives
protease inhibitors may reduce the level of serum concentration of hormonal contraceptives
protease inhibitors may reduce the level of serum concentration of hormonal contraceptives
may enhance the serum concentration of P-glycoprotein/ABCB1 inhibitors
may enhance the serum concentration of CYP3A4 inhibitors
may increase the hypoglycemic effect of direct-acting viral agents
may increase the hypoglycemic effect of direct-acting viral agents
may increase the hypoglycemic effect of direct-acting viral agents
may increase the hypoglycemic effect of direct-acting viral agents
may increase the hypoglycemic effect of direct-acting viral agents
may enhance the serum concentration of P-glycoprotein/ABCB1 inhibitors
may decrease the anticoagulant effect of direct-acting viral agents
may decrease the anticoagulant effect of direct-acting viral agents
may decrease the anticoagulant effect of direct-acting viral agents
may decrease the anticoagulant effect of direct-acting viral agents
may decrease the anticoagulant effect of direct-acting viral agents
may enhance the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors
may enhance the serum concentration of P-glycoprotein/ABCB1 inhibitors
may enhance the serum concentration of P-glycoprotein/ABCB1 inhibitors
may enhance the serum concentration of P-glycoprotein/ABCB1 inhibitors
may enhance the serum concentration of P-glycoprotein/ABCB1 inhibitors
When simeprevir is used together with ouabain, this leads to reduction in simeprevir excretion
may enhance the serum concentration
may enhance the serum concentration when combined
estrogens esterified/methyltestosterone            Â
may diminish the serum concentration of estrogen derivatives
the rate of excretion of simeprevir may be reduced
Actions and Spectrum:Â
Frequency definedÂ
>10%Â
Hyperbilirubinemia grade 1(22%)Â
Myalgia (27%)Â
Pruritus (12%)Â
Hyperbilirubinemia grade 2 (16%)Â
Rash including photosensitivity (28%)Â
Dyspnea(12%)Â
1-10%Â
Alkaline phosphatase elevation, grade 1(3%) Hyperbilirubinemia, grade 3 (4%)Â
<1%Â
Alkaline phosphatase elevation, grade 2(3%) Hyperbilirubinemia, grade 4 (4%)Â
Black box warning:Â
All patients are tested for evidence of current or past hepatitis B virus (HBV) infection before starting treatment with HCV direct-acting antivirals (DDAs). This is because HBV reactivation has been reported in HCV/HBV coinfected patients who underwent or completed DDA treatment but were not receiving HBV antiviral therapy.
This reactivation sometimes leads to severe hepatitis, liver failure, and even death. Therefore, it is crucial to monitor HCV/HBV coinfected patients for any signs of hepatitis flare or HBV reactivation during and after HCV treatment. Appropriate patient management for HBV infection should be initiated based on clinical indicationsÂ
Contraindications/caution:Â
Contraindications:Â
Caution:Â
Pregnancy consideration: It should not be used during pregnancy, as it may harm the fetus or the nursing infantÂ
Lactation: Excretion of the drug in human breast milk is unknownÂ
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
Pharmacology:Â
simeprevir is a protease inhibitor that blocks the activity of a protein called NS3/4A protease. This protein is essential for the replication of HCV, and by inhibiting its activity, simeprevir can prevent the virus from reproducingÂ
Pharmacodynamics:Â
The pharmacodynamics of simeprevir involves its ability to inhibit HCV’s NS3/4A protease protein, resulting in a rapid reduction in viral load and eventual clearance of the virus. The drug is most effective against genotype 1 HCV and may lead to the emergence of drug-resistant strains. The drug is often combined with other medications to achieve optimal response rates.Â
Pharmacokinetics:Â
AbsorptionÂ
simeprevir is well-absorbed from the gastrointestinal tract, and food increases its systemic exposure by 60-70%. Peak plasma concentrations are achieved 4-6 hours after dosing, and the predose plasma concentration is 1936 ng/mL. The area under the plasma concentration-time curve (AUC) is 57,469 ng•hr/mL Â
DistributionÂ
simeprevir is highly protein-bound (>99.9%) and is distributed mainly to the liver and other organs. Â
MetabolismÂ
simeprevir is primarily metabolized by the CYP3A enzyme, with minor contributions from CYP2C8 and CYP2C19. It inhibits the OATP1B1/3 and P-gp transporters, which can affect the pharmacokinetics of other drugs. simeprevir also mildly inhibits CYP1A2 and intestinal CYP3A but does not affect hepatic CYP3A4 activityÂ
Elimination and ExcretionÂ
The half-life of simeprevir is 41 hours in patients with hepatitis C virus infection and 10-13 hours in uninfected individuals. simeprevir is primarily eliminated through the feces (91%), with only a tiny amount (<1%) excreted in the urineÂ
Administration:Â
Take the medication with or without foodÂ
Patient information leafletÂ
Generic Name: simeprevirÂ
Pronounced:  [ sim-E-pre-vir ]Â
Why do we use simeprevir?Â
simeprevir is a medication used to treat hepatitis C (HCV) infections. It belongs to protease inhibitors, which block an enzyme necessary for virus replication.Â
Some potential uses of simeprevir include:Â