Generic Daclatasvir (Daclatasvir )

Introduction

Daclatasvir is an oral antiviral agent indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults. The drug contains the active compound daclatasvir and is supplied as a 60 mg tablet. It belongs to the class of NS5A-inhibitors, which target a viral protein essential for HCV replication. The medication is approved in combination with other direct-acting antivirals (DAAs) for genotype 1-4 infections, and clinical investigations have explored its use in additional HCV genotypes and in special patient groups. Off-label applications have been reported, but they remain unapproved by major regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

What is Daclatasvir?

Daclatasvir is the generic version of well-known medications, containing the active compound daclatasvir. Our online pharmacy provides this generic alternative as a cost-effective treatment option. The drug is marketed under brand names such as Daklinza (Bristol-Myers Squibb) and Hepacure in several jurisdictions. Developed by Bristol-Myers Squibb and approved in 2015, daclatasvir is formulated as a film-coated tablet for oral administration.

How Daclatasvir Works

Daclatasvir inhibits the non-structural protein 5A (NS5A) of HCV. NS5A is a multifunctional phosphoprotein that participates in viral RNA replication, assembly of viral particles, and modulation of host-cell pathways. By binding to the dimeric interface of NS5A, daclatasvir disrupts the formation of the replication complex, leading to a rapid decline in viral RNA synthesis. The antiviral effect appears within days of the first dose, and steady-state plasma concentrations are reached after 3-5 days of once-daily dosing. Daclatasvir is primarily metabolised by the cytochrome P450 3A4 (CYP3A4) pathway and eliminated via feces.

Conditions Treated with Daclatasvir

• Chronic Hepatitis C (Genotype 1, 2, 3, or 4) - Daclatasvir is approved in combination with sofosbuvir, with or without ribavirin, for adult patients with these genotypes. Clinical trials (e.g., the ALLY-3 and ALLY-2 studies) demonstrated sustained virologic response rates (SVR12) of 90 %-95 % in treatment-naïve and treatment-experienced populations. The drug’s potency across multiple genotypes makes it a versatile component of interferon-free regimens.

The therapeutic benefit stems from the drug’s ability to suppress viral replication to undetectable levels, allowing the host immune system to clear infected hepatocytes and reducing the risk of liver fibrosis, cirrhosis, and hepatocellular carcinoma.

Off-Label and Investigational Uses of Daclatasvir

• HCV Genotype 5 and 6 - Small phase II studies have examined daclatasvir-based regimens for genotypes 5 and 6, showing promising SVR rates. These indications are not yet approved by the FDA or EMA.
• Hepatitis B Virus (HBV) Co-infection - In vitro data suggest NS5A inhibition may affect HBV replication pathways; limited case series have reported transient reductions in HBV DNA when daclatasvir was added to standard HBV therapy. This use remains investigational.
• Liver Transplant Recipients with Recurrent HCV - Clinical trials have explored daclatasvir-containing protocols to prevent graft reinfection after transplantation. While results are encouraging, the regimen is not formally approved for this purpose.

All off-label applications should be undertaken only under the direct supervision of a qualified healthcare provider. The safety profile for these uses has not been fully characterised, and regulatory approval is pending.

Is Daclatasvir the Right Medication for You?

Daclatasvir is appropriate for adult patients with chronic HCV genotype 1-4 infection who require an interferon-free regimen, especially when co-administration with sofosbuvir is indicated. It is also suitable for patients with advanced fibrosis or compensated cirrhosis where a pan-genotypic approach is desirable.

Contraindications and cautions include:

• Known hypersensitivity to daclatasvir or any tablet excipients.
• Concomitant use of strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin) because they substantially lower daclatasvir exposure.
• Pregnant or breastfeeding women, as safety data are limited.

Patients with severe hepatic impairment (Child-Pugh C) have not been studied and should avoid daclatasvir unless a specialist determines a favorable risk-benefit ratio.

Risks, Side Effects, and Interactions

Common

• Headache
• Fatigue
• Nausea

These events are usually mild to moderate and resolve without intervention.

Rare

• Insomnia
• Diarrhoea
• Elevated liver enzymes (ALT/AST)

Routine laboratory monitoring is advisable during treatment.

Serious

• Hepatic decompensation in patients with advanced cirrhosis (rare)
• Severe hypersensitivity reactions (e.g., rash, angio-edema)

Any sign of serious adverse reaction warrants immediate medical evaluation.

Drug-Drug Interactions

• CYP3A4 inducers (rifampicin, St. John’s wort, carbamazepine) markedly reduce daclatasvir plasma levels; dose adjustment is not sufficient, and co-administration should be avoided.
• CYP3A4 inhibitors (ketoconazole, ritonavir-boosted protease inhibitors) increase daclatasvir exposure; dose reduction to 30 mg once daily is recommended when used with strong inhibitors.
• Co-administration with sofosbuvir does not require dose modification and is the standard combination.

Food and Alcohol

Daclatasvir may be taken with or without food. However, heavy alcohol consumption can exacerbate liver injury and should be limited during therapy.

Use: Dosing, Missed Dose, Overdose

• Standard dosing: 60 mg tablet taken orally once daily, preferably at the same time each day. In regimens that include a strong CYP3A4 inhibitor, the dose is reduced to 30 mg once daily.
• Missed dose: Take the missed tablet as soon as you remember, unless it is close to the time of the next scheduled dose. In that case, skip the missed dose and resume the regular dosing schedule. Do not double-dose.
• Overdose: Symptoms may include dizziness, nausea, or abdominal discomfort. Seek medical attention promptly; there is no specific antidote, and treatment is supportive.

Practical precautions:

• Store tablets at 20-25 °C (68-77 °F); protect from excess moisture and heat.
• Avoid taking the medication with grapefruit juice, which can affect CYP3A4 metabolism.
• Do not operate heavy machinery or drive if you experience dizziness or fatigue.

FAQ

• What should I do with my daclatasvir tablets if I travel abroad?

  • Keep the medication in its original packaging, stored at room temperature, and carry a copy of the prescription or a physician’s letter. Check the destination country’s import regulations for personal medicinal supplies.

• Can I split the 60 mg tablet to achieve a lower dose?

  • The tablet is not scored and should not be divided. If a dose reduction is required (e.g., when combined with a strong CYP3A4 inhibitor), obtain a 30 mg formulation from a qualified pharmacy.

• What inactive ingredients are present in the daclatasvir tablet?

  • Common excipients include microcrystalline cellulose, lactose monohydrate, magnesium stearate, and hypromellose. Patients with severe lactose intolerance should discuss alternatives with their clinician.

• Does daclatasvir interfere with urine drug testing?

  • Daclatasvir is not a target of standard occupational drug screens and should not produce a positive result for controlled substances.

• Is there a difference in efficacy between generic daclatasvir and the brand-name version?

  • Generic daclatasvir must meet the same bio-equivalence standards set by regulatory agencies, ensuring comparable efficacy and safety to brand-name products such as Daklinza.

• How long does it take for daclatasvir to be fully eliminated after stopping therapy?

  • The drug’s terminal half-life is approximately 12-15 hours. After discontinuation, more than 90 % of the dose is cleared within 2-3 days, although trace amounts may persist longer in patients with severe hepatic impairment.

• Can daclatasvir be used in patients undergoing hemodialysis?

  • Daclatasvir is minimally cleared by the kidneys, and hemodialysis does not significantly affect its plasma concentration. Dose adjustment is generally not required, but clinical judgment is advised.

• What storage conditions are recommended for regions with high humidity?

  • Store tablets in a tightly sealed container with a desiccant packet, away from direct sunlight and moisture. If the ambient humidity exceeds 60 %, consider a climate-controlled cabinet.

• Are there any known food-drug interactions specific to certain cuisines?

  • No specific foods have been shown to alter daclatasvir absorption, but grapefruit and its juice can inhibit CYP3A4 and should be avoided.

• How does daclatasvir compare to older HCV therapies such as interferon-alpha?

  • Interferon-based regimens required injections, had substantial side-effects, and achieved lower SVR rates (≈50 %). Daclatasvir, as part of an all-oral DAA regimen, offers higher cure rates (>90 %), shorter treatment duration, and a markedly improved tolerability profile.

Glossary

NS5A Inhibitor

A class of antiviral agents that block the function of the non-structural protein 5A of hepatitis C virus, thereby preventing viral RNA replication and assembly.

Sustained Virologic Response (SVR)

The absence of detectable HCV RNA in the blood 12 weeks (SVR12) or 24 weeks (SVR24) after completing therapy, considered a cure.

CYP3A4

A key enzyme in the liver that metabolises many drugs; changes in its activity can increase or decrease plasma concentrations of medications that are CYP3A4 substrates.

Bio-equivalence

A regulatory standard indicating that a generic drug delivers the same amount of active ingredient into the bloodstream as the reference (brand-name) product, with no clinically relevant difference in safety or efficacy.

Buying Daclatasvir from Our Online Pharmacy

Patients seeking a reliable source of generic daclatasvir can obtain the medication through our online pharmacy. By sourcing directly from licensed international suppliers, we are able to offer the drug at a price close to the manufacturer’s cost, reducing the financial barrier for many individuals.

All tablets are verified for authenticity and potency before shipment, ensuring that you receive a product that meets stringent quality standards. Delivery is discreet, with plain-packaging options that protect your privacy, and shipping timelines are transparent-typically 7 days for express service and approximately 3 weeks for standard airmail.

Our pharmacy operates as a broker service, partnering with overseas, fully licensed pharmacies that adhere to local regulatory requirements. This model enables us to provide access to medications that may not be readily available through domestic channels, while maintaining a high level of professionalism and regulatory compliance.

Choosing our service means you benefit from:

• Affordability: Competitive pricing that makes treatment more attainable.
• Quality Assurance: Only verified, pharmaceutical-grade products are supplied.
• Privacy: Secure ordering, discreet packaging, and confidential handling of your personal information.

We are committed to supporting patients in managing their health by removing obstacles to essential therapies.

Disclaimer

The information presented about daclatasvir is intended for general educational purposes and does not substitute for professional medical advice. Treatment decisions, including any off-label use, must be made under the supervision of a qualified healthcare provider. Readers are assumed to be responsible adults capable of making informed health choices. Our online pharmacy provides access to generic daclatasvir for individuals who may encounter limited availability through conventional pharmacies or insurance programs, or who are seeking cost-effective alternatives. Always consult a medical professional before initiating, altering, or discontinuing any medication.