Hopetavir 400 mg is a nucleotide analog NS5B polymerase inhibitor designed for the treatment of chronic hepatitis C (CHC) infection. It works by preventing replication of the hepatitis C virus (HCV), thereby reducing viral load and helping achieve sustained virologic response when used as part of a combination antiviral therapy. Hopetavir has demonstrated efficacy in patients infected with HCV genotypes 1, 2, 3, and 4, including individuals co-infected with HIV-1 or those with hepatocellular carcinoma awaiting liver transplantation.

Hopetavir should never be used as monotherapy and is most effective when combined with other antiviral agents such as Ribavirin or Pegylated Interferon plus Ribavirin, depending on viral genotype and patient condition.

রেজিস্টার্ড চিকিৎসকের পরামর্শ অনুযায়ী ঔষধ সেবন করুন

Indications

Hopetavir 400 mg is indicated for:

• Treatment of chronic hepatitis C infection (CHC) as part of a combination antiviral regimen.

• Patients with HCV genotypes 1–4, including those with:

  • HIV-1 co-infection

  • Hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation)

• Individuals who are interferon-ineligible may use Hopetavir in combination with Ribavirin.

Important: Therapy and duration should be individualized according to genotype, prior treatment response, and comorbid conditions.

Therapeutic Class

• Hepatic viral infections (Hepatitis C)

Composition

Each tablet contains:

• Hopetavir 400 mg – nucleotide analog NS5B polymerase inhibitor

Pharmacology

Hopetavir 400 mg is metabolized intracellularly to form uridine analog triphosphate (GS-461203). Its mechanism of action includes:

• Inhibition of HCV NS5B polymerase, a key enzyme in viral RNA replication

• Chain termination of viral RNA, preventing further viral replication

• Binding to Mg²⁺ ions in the NS5B polymerase active site, halting viral RNA synthesis

By blocking HCV replication, Hopetavir reduces viral load and contributes to sustained viral suppression.

Dosage & Administration

• Standard dose: 1 tablet (400 mg) orally once daily, with or without food.

• Combination therapy:

  • Genotype 1 or 4: Hopetavir + Peginterferon alfa + Ribavirin for 12 weeks

  • Genotype 2: Hopetavir + Ribavirin for 12 weeks

  • Genotype 3: Hopetavir + Ribavirin for 24 weeks

  • Hepatocellular carcinoma awaiting transplantation: Hopetavir + Ribavirin for up to 48 weeks or until transplantation

Special populations:

• Pediatric patients (<18 years): Safety and efficacy not established

• Geriatric patients: No dose adjustment required

• Severe renal impairment: Dose recommendations cannot be made; monitor carefully

  রেজিস্টার্ড চিকিৎসকের পরামর্শ অনুযায়ী ঔষধ সেবন করুন

Contraindications

• Known hypersensitivity to Hopetavir or any combination therapy component

• Combination therapy with Ribavirin or Peginterferon is contraindicated in pregnancy due to teratogenic risk

• Use cautiously in patients with severe cardiac disease if combined with amiodarone

Drug Interactions

• Potent P-gp inducers (rifampicin, St. John’s wort, carbamazepine) may reduce Hopetavir efficacy

• Co-administration with amiodarone and another direct-acting antiviral may cause serious bradycardia

• Avoid combination with drugs that strongly inhibit or induce BCRP or P-gp transporters

Side Effects

Common adverse effects include:

• Fatigue, headache, nausea, insomnia, and anemia

• Pruritus, rash, myalgia, chills, diarrhea, and influenza-like illness

• Symptoms are generally mild to moderate and resolve with ongoing treatment

Precautions & Warnings

• Monitor for bradycardia if co-administered with amiodarone

• Use with caution in patients with cardiac or advanced liver disease

• Adhere strictly to combination therapy regimens; monotherapy is not recommended

Pregnancy & Lactation

• Pregnancy Category B: Use only if benefits outweigh risks; avoid if combined with Ribavirin

• Nursing mothers: Unknown if Hopetavir is excreted in breast milk; caution advised

Overdose

No specific antidote exists. Supportive care includes:

• Monitoring vital signs

• Observation of clinical status

• Symptomatic treatment as needed

Storage Conditions

• Store in a cool, dry place, protected from light

• Keep out of reach of children