Ledifos Tablet

Q1: What is Ledifos (Ledipasvir/Sofosbuvir) used for?

Ledifos is a fixed-dose combination of Ledipasvir 90mg + Sofosbuvir 400mg for the treatment of chronic hepatitis C virus (HCV) infection, particularly genotype 1 and 4. It is used in HCV-monoinfected and HIV/HCV co-infected patients.

Q2: How do Ledipasvir and Sofosbuvir work against hepatitis C?

Sofosbuvir is an NS5B polymerase inhibitor that blocks HCV RNA replication. Ledipasvir is an NS5A inhibitor that blocks viral assembly and replication. Together they target two different steps of the HCV replication cycle, achieving >95% cure rates.

Q3: What is the cure rate with Ledifos?

Ledifos (Ledipasvir/Sofosbuvir) achieves sustained virologic response (SVR, meaning cure) in >95% of treatment-naive genotype 1 patients in 8–12 weeks. SVR12 is defined as undetectable HCV RNA 12 weeks after completing treatment.

Q4: How long is Ledifos treatment?

Standard treatment is 12 weeks for most patients. Treatment-naive non-cirrhotic genotype 1 patients with low viral load may qualify for 8 weeks. Patients with cirrhosis or prior treatment experience typically require 24 weeks with ribavirin. Your hepatologist will determine duration.

Q5: How is Ledifos taken?

Take one tablet once daily with or without food. Take at a consistent time each day. The full course must be completed — stopping early significantly reduces the chance of cure.

Q6: What are the most common side effects?

Ledifos is generally very well-tolerated. Common side effects include fatigue, headache, nausea, and insomnia. These are mild and usually do not require treatment discontinuation.

Q7: What drug interactions affect Ledifos in HIV patients?

Antacids reduce Sofosbuvir absorption — separate by 4 hours. Tenofovir levels increase with Ledipasvir — extra monitoring needed. P-gp inducers (rifampicin, carbamazepine) are contraindicated as they reduce Sofosbuvir levels below therapeutic range. Full interaction screening with HIV medications is essential.

Q8: Is Ledifos safe for patients with liver disease?

Ledifos can be used in compensated cirrhosis. It is not recommended for patients with decompensated cirrhosis (Child-Pugh B or C) without specialist guidance. Renal function should be checked — Sofosbuvir requires eGFR ≥30 ml/min.

Q9: Can Ledifos be used during pregnancy?

Data in pregnancy are limited. Ribavirin (if required) is absolutely contraindicated in pregnancy. Sofosbuvir-based regimens without ribavirin may be considered in urgent cases — discuss with your hepatologist.

Q10: How will I know if Ledifos has cured my hepatitis C?

HCV RNA is tested at 4 weeks (for early virologic response), at end of treatment, and at 12 weeks after completing treatment (SVR12). Undetectable HCV RNA at SVR12 confirms cure — over 99% of patients with SVR12 remain cured long-term.

Q11: How should Ledifos be stored?

Store at room temperature away from light and moisture. Keep in original bottle with the moisture-absorbing desiccant. Keep out of reach of children.

Q12: Do I need a prescription?

Yes. Ledifos requires specialist prescribing (hepatologist or HIV/ID specialist with HCV expertise), HCV genotyping, liver fibrosis assessment, and HCV RNA monitoring during and after treatment.