Natdac

Natdac (Daclatasvir 30/60 mg) — Natco pan-genotypic NS5A inhibitor for chronic hepatitis C. Combined with sofosbuvir; preferred backbone for genotype 3.

SKU: Natdac Kategori: Kategorioversigt, Kroniske tilstande, Hepatitismedicin

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

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Natdac — daclatasvir 30/60 mg (Natco Pharma). Pan-genotypic NS5A inhibitor — used in combination with sofosbuvir to cure hepatitis C across genotypes 1-6, especially genotype 3 where it remains preferred. Generic of BMS Daklinza.

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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.

How daclatasvir works

NS5A is a multifunctional HCV protein essential for viral RNA replication and assembly. Daclatasvir binds NS5A and disrupts both replication-complex formation and virion assembly. It is potent, pan-genotypic, and well-tolerated.

Daclatasvir is always given with sofosbuvir (or another nucleotide backbone) — never as monotherapy. The combination achieves SVR12 in ≥95% of patients across genotypes, including genotype 3 (where ledipasvir-based regimens are weaker).

Standard dose is 60 mg once daily. Reduce to 30 mg with strong CYP3A4 inhibitors; increase to 90 mg with moderate inducers (where unavoidable).

Treatment-duration table

Population	Regime
Genotype 1 / 4 / 5 / 6, treatment-naive, no cirrhosis	12 weeks (typically combined with NS5A inhibitor)
Genotype 2, no cirrhosis	12 weeks (sofosbuvir + ribavirin or sofosbuvir + daclatasvir)
Genotype 3, no cirrhosis	12 weeks sofosbuvir + daclatasvir (sofosbuvir + velpatasvir is pan-genotypic alternative)
Compensated cirrhosis (any genotype)	12 weeks combination DAA + ribavirin in selected cases; 24 weeks if treatment-experienced

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

Important drug interactions

Lægemiddel	Effect & action
Amiodarone + sofosbuvir	FDA 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, rifabutin	Strong CYP3A4 + P-gp inducers — significantly reduce DAA levels. Avoid combination.
St John’s wort	CYP3A4 induction — reduces DAA levels and risks treatment failure. Avoid throughout therapy.
Phenytoin, carbamazepine, oxcarbazepine	Anticonvulsant 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.
Warfarin	INR can fluctuate as the liver recovers during DAA therapy. Monitor INR weekly until stable.
HIV antiretrovirals	Tenofovir + 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.

Pregnancy?

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.

Side effects?

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.

Natdac (daclatasvir 60 mg) is taken alongside sofosbuvir for several genotypes, but for genotypes 1, 4, 5 and 6 the single-tablet Hepcinat LP (sofosbuvir 400 mg + ledipasvir 90 mg) consolidates both agents and improves adherence over the two-tablet daily regimen.

Other Hepatitis C Medications

MyHep — sofosbuvir 400 mg — combination partner for daclatasvir
Hepcinat — sofosbuvir 400 mg — Natco brand
Hepcvir — sofosbuvir 400 mg — Cipla brand
Velpanat — sofosbuvir + velpatasvir — alternative pan-genotypic single tablet
Ledifos — sofosbuvir + ledipasvir for genotypes 1, 4, 5, 6

Medicinsk ansvarsfraskrivelse: This page is for information only and is not a substitute for medical advice from a qualified clinician. Discuss any new medication with your doctor or pharmacist.