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Ledifos

Ledifos (Sofosbuvir + Ledipasvir 400 + 90 mg) — Hetero generic of Harvoni. 12-week fixed-combination tablet for genotypes 1, 4, 5, and 6.

Medicinsk gennemgået af Morgan Ellis — Apoteksforsker · 8 års erfaring  · Sidst gennemgået: maj 2026

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Ledifos — sofosbuvir 400 mg + ledipasvir 90 mg fixed combination (Hetero Drugs). Single-tablet regimen for chronic hepatitis C genotypes 1, 4, 5, 6 — 12 weeks once-daily oral therapy. Cure rate ≥95%. Generic of Gilead Harvoni.

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Ledifos ships from a WHO-GMP certified manufacturer in plain packaging, billed through a regulated payment processor (the statement descriptor reads a regulated card-payment processor — never MedsBase or any medication name). Every order carries our 20-business-day Reshipment Assurance.

FDA black-box: HBV reactivation
All DAA Hep C therapies carry an FDA black-box warning for hepatitis B virus reactivation in patients co-infected with HCV + HBV (which can be fulminant and fatal). Test for HBsAg and HBV DNA before starting any DAA regimen. If HBV-positive, hepatology must manage co-treatment or prophylactic anti-HBV therapy.

Sådan virker det

Two complementary direct-acting antivirals in one tablet:

  • Sofosbuvir — NS5B nucleotide polymerase inhibitor (chain terminator)
  • Ledipasvir — NS5A inhibitor (replication and virion assembly)

Combined attack on two essential viral proteins gives a high barrier to resistance. The combination is genotype 1/4/5/6-active. For genotypes 2 and 3, sofosbuvir + velpatasvir or sofosbuvir + daclatasvir are preferred.

Take with food; mind the PPIs
Ledipasvir absorption is pH-dependent. Take with food to maximise levels. PPIs (omeprazole, pantoprazole) reduce ledipasvir absorption — take the DAA tablet first thing in the morning before any PPI dose, OR switch to H2 blockers (famotidine) or antacids during therapy. Antacids should be separated by ≥4 hours.

Treatment-duration table

PopulationRegime
Genotype 1, 4, 5, 6, treatment-naive, no cirrhosis12 weeks one tablet daily
Treatment-naive with compensated cirrhosis12 weeks (24 weeks if difficult-to-treat profile)
Treatment-experienced, no cirrhosis12 uger
Treatment-experienced with cirrhosis12 weeks + ribavirin OR 24 weeks without
Decompensated cirrhosis (Child-Pugh B/C)12 weeks + ribavirin (specialist hepatology supervision)

Sustained virologic response at 12 weeks post-treatment (SVR12) is the marker of cure — achieved in ~95-99% of patients across modern DAA regimens.

Vigtige lægemiddelinteraktioner

LægemiddelEffect & action
Amiodarone + sofosbuvirFDA warning — symptomatic bradycardia, deaths reported. Avoid combination. If unavoidable, in-hospital cardiac monitoring required.
PPIs (omeprazole, pantoprazole)Reduce ledipasvir absorption (pH-dependent). Take ledipasvir-containing regimens with food and PPIs ≥4 hours apart, or use H2 blockers/antacids instead. Velpatasvir also pH-sensitive — same advice.
Rifampicin, rifabutinStrong CYP3A4 + P-gp inducers — significantly reduce DAA levels. Avoid combination.
SankthansurtCYP3A4 induction — reduces DAA levels and risks treatment failure. Avoid throughout therapy.
Phenytoin, carbamazepine, oxcarbazepineAnticonvulsant inducers — significantly reduce DAA levels. Switch to non-inducing antiepileptic (lamotrigine, levetiracetam) before starting Hep C therapy.
Statins (rosuvastatin, atorvastatin)Variable rises in statin levels. Use lowest dose; rosuvastatin generally avoided with sof+vel; atorvastatin acceptable at low dose.
WarfarinINR can fluctuate as the liver recovers during DAA therapy. Monitor INR weekly until stable.
HIV antiretroviralsTenofovir + ledipasvir — increased tenofovir exposure; monitor renal function. Efavirenz reduces velpatasvir levels — avoid combination. HCV-HIV co-infection always needs ID/hepatology specialist input.

Ofte stillede spørgsmål

What is the cure rate?

Modern DAA regimens achieve sustained virologic response (SVR12) — undetectable HCV RNA at 12 weeks post-treatment, considered cure — in 95-99% of patients across genotypes. Cirrhosis, prior treatment failure, and HCV/HIV co-infection slightly reduce response rates.

What is SVR12?

Sustained Virologic Response at 12 weeks post-treatment. After completing a 12-week DAA course, HCV RNA is checked at 12 weeks after the last dose. Undetectable = cure. Late relapse beyond SVR12 is <1%.

Will I need a follow-up test?

Yes. HCV RNA at the end of treatment + at 12 weeks post-treatment confirms SVR12. Liver biochemistry and FibroScan/imaging at 6-12 months in cirrhotic patients to assess regression. Even after cure, screen for hepatocellular carcinoma every 6 months if cirrhosis is established.

What about hepatitis B?

All DAAs carry an FDA black-box warning for HBV reactivation in HCV+HBV co-infected patients. Test HBsAg and HBV DNA before starting. If HBV-positive, hepatology must coordinate.

Kan jeg drikke alkohol?

Avoid alcohol throughout treatment and ideally for 6-12 months after. Active alcohol use does not preclude DAA therapy but worsens long-term liver outcomes regardless of HCV status.

Graviditet?

Sofosbuvir is FDA pregnancy category B (no human teratogenicity data; animal data reassuring). Most DAAs lack pregnancy data. Contraception during therapy is standard. Ribavirin (where used as adjunct) is strongly teratogenic — both partners must use contraception during ribavirin therapy and 6 months after.

Bivirkninger?

Modern DAAs are generally well tolerated. Common: fatigue, headache, nausea, insomnia. Less common: rash, diarrhoea. Treatment-limiting side effects are rare.

Generic vs branded — does it matter?

Indian generic DAAs are manufactured under voluntary licences from Gilead (Sovaldi, Harvoni, Epclusa), AbbVie, and BMS. They are bioequivalent and have the same molecule. Multiple real-world studies (CT2, Plus-Asia) show equivalent SVR12 rates to branded products.

Drug interactions to watch?

Most important: amiodarone + sofosbuvir (bradycardia black-box), rifampicin (kills DAA levels), PPIs (reduce ledipasvir/velpatasvir), HIV ARV adjustments needed in co-infection. Always disclose all medications including herbal/OTC.

After cure — can I get HCV again?

Yes. SVR clears the current infection but does not provide future immunity. Re-infection through new exposures (IV drug use, unsafe medical procedures, MSM with HIV co-infection) is possible. Counsel on prevention and offer HCV RNA testing at any new risk exposure.

Se også: this generic Harvoni — Natco’s generic Harvoni — sofosbuvir 400 mg + ledipasvir 90 mg in a single 12-week course for hepatitis C genotypes 1, 4, 5, 6.

Other Hepatitis C Medications

  • Velpanat — sofosbuvir + velpatasvir — pan-genotypic alternative including G2 and G3
  • Hepcvel — sofosbuvir + velpatasvir — Cipla brand
  • Natdac — daclatasvir 30/60 mg — alternative NS5A inhibitor for sofosbuvir partner
  • MyHep — sofosbuvir 400 mg monotherapy backbone
  • Hepcvir — sofosbuvir 400 mg — Cipla brand
Medicinsk ansvarsfraskrivelse: Denne side er kun til informationsformål og er ikke en erstatning for lægevejledning fra en kvalificeret kliniker. Drøft eventuel ny medicin med din læge eller apoteker.

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Styrke

90 mg + 400 mg

Antal

28 Tablet/s, 56 Tablet/s, 84 Tablet/s

Farmaceutisk form

Tablet/s

Producent

Hetero Drugs

Behandling

Hepatitis C

Generisk mærke

Ledipasvir & Sofosbuv

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