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Sofosbuvir: Brands, Price & Uses in Bangladesh

Sofosbuvir is a direct-acting antiviral (DAA), specifically a nucleotide analog inhibitor of the hepatitis C virus (HCV) NS5B RNA-dependent RNA polymerase.

Forms:Tablet

About Sofosbuvir

Indications of Sofosbuvir

Sofosbuvir is a direct-acting antiviral (DAA), specifically a nucleotide analog inhibitor of the hepatitis C virus (HCV) NS5B RNA-dependent RNA polymerase. It is indicated for the treatment of chronic hepatitis C virus infection in adults and pediatric patients, always as part of a combination antiviral regimen — Sofosbuvir is never used as monotherapy.

Established / approved combination regimens

  • Genotype 1 or 4: Sofosbuvir with peginterferon alfa and ribavirin.
  • Genotype 2: Sofosbuvir with ribavirin.
  • Genotype 3: Sofosbuvir with ribavirin (with or without peginterferon alfa, per treatment history and guideline recommendation).
  • HCV/HIV-1 co-infection: Sofosbuvir-based combination regimens selected as for HCV mono-infected patients, per current guidelines.

Guideline-supported interferon-free combinations

Current international treatment guidelines (e.g. AASLD-IDSA, WHO) also support interferon-free, all-oral regimens that combine Sofosbuvir with another direct-acting antiviral such as ledipasvir, velpatasvir, or daclatasvir, chosen according to HCV genotype and prior treatment history. These fixed or co-administered combinations are the preferred standard of care in many settings but must be prescribed and dispensed as directed by a qualified physician.

Sofosbuvir is not indicated for acute hepatitis C, hepatitis B, or hepatitis A, and is not effective against non-HCV viral infections.

Dosage & Administration of Sofosbuvir

Adult dosing

Indication / GenotypeRegimenTypical Duration
Genotype 1 or 4Sofosbuvir 400 mg once daily + peginterferon alfa + ribavirin12 weeks
Genotype 2Sofosbuvir 400 mg once daily + ribavirin12 weeks
Genotype 3Sofosbuvir 400 mg once daily + ribavirin (± peginterferon alfa)24 weeks
Interferon-ineligible / interferon-free (guideline-directed)Sofosbuvir + another DAA (e.g. ledipasvir, velpatasvir, daclatasvir) per current guidelines8–24 weeks, regimen-dependent

Pediatric dosing (weight-based, age 3 years and older, genotype 2 or 3, with ribavirin)

Body weightSofosbuvir dose
17 kg to less than 35 kg200 mg once daily
35 kg or more400 mg once daily

Administration

Take one tablet orally, once daily, with or without food. Swallow the tablet whole; do not chew or crush unless a formulation specifically permits it. Take Sofosbuvir at approximately the same time each day and complete the full prescribed treatment course, even if symptoms improve, to reduce the risk of treatment failure and viral resistance.

Missed dose

If a dose is missed and remembered within 18 hours of the usual time, take it as soon as possible and resume the normal schedule. If more than 18 hours have passed, skip the missed dose and continue with the next scheduled dose; do not double the dose.

Side Effects of Sofosbuvir

The most commonly reported adverse effects with Sofosbuvir-based regimens include:

  • Fatigue
  • Headache
  • Nausea
  • Insomnia

When Sofosbuvir is combined with ribavirin and/or peginterferon alfa, additional effects commonly seen include anemia, rash, diarrhea, irritability, and neutropenia — these are generally attributable to the companion drugs rather than Sofosbuvir itself.

Hepatitis B virus (HBV) reactivation has been reported in patients coinfected with HBV and HCV who were treated with Sofosbuvir-containing regimens, in some cases with serious or fatal outcomes. See Precautions and Warnings for required screening before starting treatment.

Seek prompt medical attention for any signs of an allergic reaction (rash, swelling, difficulty breathing), unusually slow or irregular heartbeat, dizziness, or fainting.

Contraindications of Sofosbuvir

  • Known hypersensitivity to Sofosbuvir or any component of the formulation.
  • Coadministration with amiodarone in a Sofosbuvir-containing antiviral regimen — this combination is contraindicated/not recommended because of the risk of severe, symptomatic bradyarrhythmia, which has been fatal in some reported cases.
  • Coadministration with potent P-glycoprotein (P-gp) inducers that significantly reduce drug absorption and lower plasma concentrations of Sofosbuvir, risking loss of virologic response — including rifampin, rifabutin, rifapentine, carbamazepine, phenytoin, and St. John's Wort (Hypericum perforatum).
  • When Sofosbuvir is combined with ribavirin (with or without peginterferon alfa), all contraindications applicable to ribavirin (including pregnancy in the patient or her partner) and to peginterferon alfa also apply to that combination regimen.

Frequently Asked Questions about Sofosbuvir

What is Sofosbuvir used for?

Sofosbuvir is an antiviral medicine used to treat chronic hepatitis C virus (HCV) infection in adults and children 3 years and older. It works by blocking an enzyme the hepatitis C virus needs to copy itself. Sofosbuvir is always given together with at least one other antiviral medicine (such as ribavirin, with or without peginterferon alfa, or another direct-acting antiviral) and is never used alone.

Can I take Sofosbuvir on its own, without any other medicine?

No. Sofosbuvir must never be taken as monotherapy. It is only effective and only approved for use as part of a combination antiviral regimen. Taking Sofosbuvir alone will not adequately treat hepatitis C and increases the risk that the virus becomes resistant to treatment.

Is it safe to take Sofosbuvir if I am pregnant or breastfeeding?

Sofosbuvir should be used in pregnancy only if clearly needed, with a physician's guidance, as data in human pregnancy are limited. Importantly, if Sofosbuvir is combined with ribavirin, that combination must not be used during pregnancy, or by men whose partner is pregnant, because ribavirin can cause serious birth defects. It is not known whether Sofosbuvir passes into breast milk, so breastfeeding mothers should consult their physician before use.

Can I take amiodarone (a heart medicine) together with Sofosbuvir?

No. Combining amiodarone with a Sofosbuvir-containing antiviral regimen can cause serious, sometimes fatal, slowing of the heart rate (bradycardia). Tell your physician about all heart medicines you take before starting Sofosbuvir, and never combine it with amiodarone unless your physician has determined there is no alternative and arranged close cardiac monitoring.

Do I need any tests before starting Sofosbuvir?

Yes. Your physician should test you for hepatitis B virus (HBsAg and anti-HBc) before you start Sofosbuvir-containing treatment, because hepatitis B can reactivate — sometimes seriously — in people also infected with hepatitis C who start antiviral treatment. Routine liver function and kidney function monitoring may also be recommended during treatment.

What should I do if I miss a dose or think I have taken too much Sofosbuvir?

If you miss a dose within 18 hours of your usual time, take it as soon as you remember; if more than 18 hours have passed, skip it and take your next dose as scheduled — do not double the dose. If you suspect you have taken too much Sofosbuvir, seek immediate medical attention or contact a poison control center; there is no specific antidote, but supportive care is effective.

Disclaimer

The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.

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