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Sofosbuvir and Ledipasvir

Sofosbuvir & ledipasvir Drug profile

Sofosbuvir and ledipasvir are categorized as Anti-viral medication, whereas Sofosbuvir is nucleotide polymerase inhibitors. Ledipasvir is an HCV NS5A inhibitor.

Both Sofosbuvir and ledipasvir expels its activity by reducing the extent of hepatitis C virus

Sofosbuvir and ledipasvir are a fixed-dose combination, maintains a potent and well-tolerated for the therapy of genotypes I, IV, V and VI chronic hepatitis C (HCV) infection.

Sofosbuvir and ledipasvir are directly acting anti-viral regimen which is FDA approved product.

Sofosbuvir & ledipasvir Drug profile

Sofosbuvir and ledipasvir are categorized as Anti-viral medication, whereas Sofosbuvir is nucleotide polymerase inhibitors. Ledipasvir is an HCV NS5A inhibitor.

Both Sofosbuvir and ledipasvir expels its activity by reducing the extent of hepatitis C virus

Sofosbuvir and ledipasvir are a fixed-dose combination, maintains a potent and well-tolerated for the therapy of genotypes I, IV, V and VI chronic hepatitis C (HCV) infection.

Sofosbuvir and ledipasvir are directly acting anti-viral regimen which is FDA approved product.

Sofosbuvir & ledipasvir Drug Prescribing Information

Combination of Sofosbuvir and ledipasvir are either used alone or combined with other anti-viral medicines like ribavirin to treat advanced or decompensated cirrhosis

In Adults:

Sofosbuvir and ledipasvir are indicated for the treatment of adolescent patients with chronic hepatitis C viral infection

  1. Genotype I, IV, V or VI infection without cirrhosis or with compensated cirrhosis
  2. Genotype I infection with decompensated (Child-Pugh B or C) treats by combining with ribavirin
  3. Genotype I or IV infection in liver transplant recipients without cirrhosis or compensated cirrhosis treats by combining with ribavirin

In pediatrics:

Both Sofosbuvir and ledipasvir are used in the pediatric patient with 12 years of age and older or weight about 350kg

  1. HCV genotype I, IV, V or VI infection without cirrhosis or with compensated cirrhosis

Sofosbuvir & ledipasvir Mechanism of Action

Pharmacological category:

  • Anti-hepaciviral NS5A inhibitor
  • Anti-hepaciviral polymerase inhibitor
  • NS5A inhibitor
  • NS5B RNA polymerase inhibitor

Sofosbuvir, after administered orally it goes into hepatitis C virus and binds to the NS5B polymerase, an enzyme which is a key component for viral replication. Sofosbuvir inhibits HCV NS5B protein and interfere with viral multiplication

Ledipasvir, NS5A inhibitor (NS5A is a viral phosphoprotein); which is essential for viral proliferation, accumulation, and movement

Absorption:

The peak plasma concentration of ledipasvir is 4 to 4.5 hours; Sofosbuvir is 0.8 to 1 hour and GS-331007 is 3.5 to 4 hour

The peak plasma level for;

Ledipasvir 323ng/ml; Sofosbuvir 618ng/ml and GS-331007 707ng/ml

Distribution:

The human plasma protein bound with ledipasvir, Sofosbuvir and GS-331007 is>99.8%, 61 to 65% and minimal respectively

Metabolism:

Ledipasvir is not metabolized it is excreted as such through feces; slow oxidation metabolism occurs. Sofosbuvir intensively metabolized hepatically to form pharmacologically active nucleoside analog triphosphate GS-461203; Dephosphorylation concluded the formation of GS-331007.

Elimination:

The route of elimination of ledipasvir, GS-331007

Ledipasvir: >98% feces; 1% in urine in unchanged form

GS-331007: 14% feces; 80% through urine and 2.5% in exhaled air

The mean terminal half-life period of;

Ledipasvir: 47 hours; Sofosbuvir: 0.5 hours and GS-331007: 27 hours

When to take the drug Sofosbuvir and Ledipasvir

This fixed dose combinational medicine comes in tablet form; usually, one tablet should be taken orally as a single dose.

This should be taken with or without food

Sofosbuvir and ledipasvir are prescription medicine; it must be used only under the guidance of medical hepatologist.

Dosage Regimens

In adults:

The prescribed dose of Sofosbuvir and ledipasvir in adults are;

One tablet 90mg/400mg to be taken as a single dose

Patients acquired without cirrhosis or with compensated cirrhosis:

Sofosbuvir and ledipasvir should be taken as a single dose orally for 12 weeks

Therapy-experienced without cirrhosis:

Sofosbuvir and ledipasvir took as once a day for 12 weeks

Therapy-experienced with compensated cirrhosis:

Sofosbuvir and ledipasvir should be taken as a single dose for 24 weeks alone or in combination with ribavirin.

In decompensated cirrhosis:

Sofosbuvir and ledipasvir combined with weight-based ribavirin followed for 12 weeks

Ribavirin dosage regimen:

<75kg: 1000mg per day

≥75kg: 1200mg per day

In Genotype I or IV:

Spontaneous therapy and therapy competent without cirrhosis or with compensated cirrhosis:

Sofosbuvir and ledipasvir with ribavirin for 12 weeks as a single dose.

In genotype IV, V or VI:

Therapy-experienced and therapy naïve without cirrhosis or with compensated cirrhosis:

Sofosbuvir and ledipasvir took a single dose for 12 weeks.

Dosage adjustment:

In renal and hepatic impairment patients, mild or moderate conditions, on dosage adjustments required

In decompensated condition, safety and efficacy have not been established.

In pediatric:

Used for HCV infection:

Sofosbuvir and ledipasvir is majorly indicated in pediatric patients with the age of 12 or older or weight of 35kg

<12 years or <35kg: the safety and efficacy has not been established

≥12 years or ≥35kg: one tablet to be taken as a single dose.

Duration of therapy:

Genotype I:

Therapy naïve with compensated cirrhosis or without cirrhosis:

Sofosbuvir & ledipasvir for 12 weeks as a single dose.

Therapy-experienced without cirrhosis:

Sofosbuvir and ledipasvir taken orally as a single dose for 12 weeks.

Therapy naïve and experienced without cirrhosis or with compensated cirrhosis:

Sofosbuvir and ledipasvir for 24 weeks.

Genotype IV, V or VI:

Therapy naïve and experienced without cirrhosis or with compensated cirrhosis:

Sofosbuvir and ledipasvir followed for 12 weeks as a single dose.

Drug Called side effects

While taking Sofosbuvir and ledipasvir, some side effects acquired in patients

>10%

Asthenia, fatigue, headache, cough

1-10%:

Nausea, diarrhea, dizziness, dyspnea, insomnia, increased bilirubin, elevation of lipase, Myalgia, irritability

Elevation of creatine kinase asymptomatically

Serious bradycardia, skin rash, angioedema like swelling

Chest pain or discomfort

Irregular heartbeats

Shortening of breath

Unusual tiredness

Drug Interaction:

Ledipasvir: Drug transporter P-gp inhibitors and breast cancer resistance protein inhibitor, while concomitant with Sofosbuvir and ledipasvir may causes increase the intestinal absorption of these substrates

With antacids: like proton pump inhibitors, H2 receptor antagonist causes reduce effect of concentration of ledipasvir

With amiodarone: serious bradycardia occurs

With digoxin: increase the effect of concentration of digoxin

With anti-convulsants: reduce the effect of concentration of Sofosbuvir and ledipasvir

With anti-mycobacterials: reduce the effect of concentration of Sofosbuvir and ledipasvir

With HMG CoA reductase: increase the effect of concentration of these lipid mimic drugs.

Food -Drug Interactions

Both anti-viral medicines like Sofosbuvir and ledipasvir are interact with food and herbs and may leads to reduce the therapeutic effect of these viral medicines

While using these anti-viral medicines with St. Johns wort, may lead to reduce the effect of concentration of Sofosbuvir and ledipasvir, avoid this combination.

Possible Contraindications

While combining Sofosbuvir and ledipasvir with ribavirin, contraindicated in pregnancy conditions

Hypersensitivity reaction occurs in patients who are contraindicated to either Sofosbuvir or ledipasvir.

Safety Measures       

Rejuvenation of HBV happens in HCV/HBV co-infected patients experienced or had therapy with precisely acting anti-viral drugs and not receiving HBV anti-viral treatment

Before starting the therapy with Sofosbuvir and ledipasvir, patient should be investigate for evidence of ongoing or previous hepatitis B virus infection

In some condition fulminant hepatitis, hepatic failure and death occurs

Symptomatic bradycardia occurs while combined with amiodarone

Therapeutic effect decreased by combining with P-gp inducers.

Pregnancy and Lactation

During monotherapy: Sofosbuvir and ledipasvir are used alone

Pregnancy category of these drugs: B1; safe to use after getting advice from a medial hepatologist

During combinational therapy: Sofosbuvir and ledipasvir with ribavirin

Ribavirin comes under a category: X

Causes of fetal harm lead to death

Breastfeeding is not recommended.

Storage and Handling

Sofosbuvir and ledipasvir are stored at room temperature below 30oC (86oF)

Keep away from moisture, heat, and light.

Missed Dose

Both the anti-viral medicines are prescription use, before taking the tablet patient must advise by a physician for avoiding self-medication

If the patient fails to take the dose, must consult with a medical practitioner and administered the missed dose as soon as possible

Otherwise, the missed dose should be skipped and maintain the regular dosing schedule

Do not take an overdose.

Overdosage

The maximum dose of Sofosbuvir and ledipasvir were 1200mg and 120mg twice daily for 10days.

No special antidote is recommended for overdosage of ledipasvir and Sofosbuvir

If overdosage of both drugs, patients should be examined for confirmation of toxicity

Hemodialysis is suitable for elimination of ledipasvir hence; ledipasvir is largely bound to plasma protein and also helps to expel the dominant circulating metabolite of Sofosbuvir GS-331007 with the range of 53%

Other precaution: in case of overdosage, contact poison information center as soon as possible.

List of brands available for Sofosbuvir and Ledipasvir:

 

Brands available

 

 

Manufacturer

 

Hepcvir L

 

 

Cipla

 

Hepcinat LP

 

 

Natco

 

Resof L

 

 

Dr.Reddy’s

 

Ledihep

 

 

Zydus Hepatica

 

Virpas

 

 

Strides

 

Ledviclear

 

 

Abbott

 

Ledifos

 

 

Hetero Healthcare

 

Myhep LVIR

 

 

Mylan


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