Generic Daklinza

Introduction

Daklinza (generic name : daclatasvir) is an antiviral medication approved for the treatment of chronic hepatitis C virus (HCV) infection. Developed by Bristol‑Myers Squibb, it belongs to the class of direct‑acting antivirals (DAAs) that target viral replication. In the United Kingdom, Daklinza is used as part of combination regimens that aim to achieve a sustained virologic response (SVR), effectively curing HCV in the majority of treated patients. The drug’s high barrier to resistance and once‑daily dosing make it a central component of modern HCV therapy.

What is Daklinza?

Daklinza is a tablet formulation containing the active compound daclatasvir, a selective inhibitor of the HCV non‑structural protein 5A (NS5A). NS5A is essential for viral RNA replication and assembly of infectious particles. The medication received marketing authorization in the EU in 2015 and has since been incorporated into national HCV treatment guidelines. It is supplied in 60 mg tablets, each tablet delivering the full therapeutic dose used in most approved regimens.

How Daklinza Works

Daclatasvir binds to a highly conserved region of the NS5A protein, preventing the formation of the replication complex required for viral RNA synthesis. By blocking this step, the drug halts the production of new viral genomes and reduces circulating viral load rapidly. The antiviral effect appears within a few days of the first dose, and steady‑state plasma concentrations are reached after approximately 4 days of once‑daily administration. Daclatasvir is metabolised primarily by CYP3A4 and excreted in the feces; its half‑life of roughly 12–15 hours supports once‑daily dosing without the need for therapeutic drug monitoring in most patients.

Conditions Treated with Daklinza

• Chronic Hepatitis C infection (genotype 1, 2, 3, and 4) – Used in combination with other DAAs such as sofosbuvir, ledipasvir, or velpatasvir, depending on genotype and prior treatment experience.
• HCV infection in patients with compensated cirrhosis – Clinical trials demonstrated comparable SVR rates in patients with early‑stage liver fibrosis and those with cirrhosis, provided appropriate combination therapy is selected.

In the UK, an estimated 200 000–300 000 individuals are living with chronic HCV, and the National Health Service (NHS) recommends DAA‑based regimens as first‑line therapy. Daklinza’s pan‑genotypic activity and favourable safety profile contribute to the UK’s goal of eliminating HCV as a public health threat by 203.

Who is Daklinza For?

• Treatment‑naïve adults with genotype 1, 2, 3, or 4 HCV who are eligible for an interferon‑free regimen.
• Patients who have previously failed a DAA regimen (e.g., sofosbuvir‑based) and require a rescue protocol that includes an NS5A inhibitor with a high resistance barrier.
• Individuals with compensated cirrhosis (Child‑Pugh A) where a 12‑week course of Daklinza‑containing therapy provides SVR rates exceeding 95 % in clinical studies.
• Patients with renal impairment (eGFR ≥ 30 mL/min/1.73 m²), as daclatasvir does not require dose adjustment in mild to moderate kidney disease.

Contra‑indications include co‑administration with strong CYP3A inducers (e.g., rifampicin, carbamazepine) and known hypersensitivity to daclatasvir or any tablet excipient. Caution is advised in patients with moderate to severe hepatic impairment (Child‑Pugh B/C) because exposure may increase.

Risks, Side Effects, and Interactions

Common

• Headache
• Fatigue
• Nausea
• Diarrhoea

These events are typically mild to moderate, transient, and do not usually require discontinuation of therapy.

Rare

• Elevated liver enzymes (ALT/AST) in patients with pre‑existing liver disease
• Insomnia
• Rash

Patients should report persistent or worsening symptoms to their healthcare provider.

Serious

• Hepatic decompensation – Rare but reported in patients with advanced cirrhosis, especially when combined with other hepatotoxic agents.
• Severe allergic reactions (anaphylaxis, angio‑edema) – Immediate medical attention is required.

Drug–Drug Interactions

• Strong CYP3A inducers (rifampicin, carbamazepine, St. John’s wort) markedly reduce daclatasvir exposure → loss of efficacy.
• CYP3A inhibitors (ketoconazole, clarithromycin, HIV protease inhibitors) increase exposure → consider dose reduction of daclatasvir to 30 mg once daily when co‑administered with sofosbuvir.
• Combination with amiodarone may predispose to bradyarrhythmias; cardiac monitoring is recommended.

Patients should provide a complete medication list, including over‑the‑counter products and herbal supplements, to avoid potentially harmful interactions.

Practical Use: Dosing, Missed Dose, Overdose

• Standard dosing: 60 mg (one tablet) taken orally once daily, with or without food. The tablet may be swallowed whole; crushing is not advised.
• Combination regimens: The dose of Daklinza remains 60 mg when co‑administered with sofosbuvir, ledipasvir, or velpatasvir, unless a CYP3A inhibitor is present (dose may be reduced to 30 mg).
• Missed dose: Take the missed tablet as soon as remembered on the same day; do not take a double dose the following day.
• Overdose: No specific antidote exists. If an overdose is suspected, seek emergency medical care; supportive measures include monitoring of cardiac rhythm and liver function.
• Food and alcohol: Food does not significantly affect absorption, so the medication can be taken with meals. Moderate alcohol consumption is permissible, but patients with advanced liver disease should limit intake.
• Comorbidities: No dose adjustment is required for mild‑to‑moderate renal impairment. In severe hepatic impairment (Child‑Pugh B/C), use is not recommended due to limited safety data.

Buying Daklinza from Our Online Pharmacy

Daklinza can be purchased from our online pharmacy in the UK with a focus on safety, affordability, and confidentiality.

• Affordable pricing – We source the medication close to manufacturer cost, passing savings directly to you.
• Verified quality – All batches are obtained from licensed overseas suppliers who meet Good Manufacturing Practice (GMP) standards; each shipment is accompanied by a certificate of analysis.
• Guaranteed delivery – Discreet packaging is shipped via express (typically 7 days) or regular airmail (approximately 3 weeks), with tracking available for every order.
• Online‑only access – Our pharmacy broker service collaborates with internationally accredited pharmacies, enabling patients who face limited local supply or insurance barriers to obtain the medication legally and securely.
• Privacy protection – We adhere to strict data‑protection policies, ensuring that personal and medical information remains confidential throughout the ordering process.

FAQ

• Is Daklinza approved for use in children or adolescents?
  Daklinza has not been evaluated in paediatric populations, and it is not authorised for individuals under 18 years of age. Treatment decisions for younger patients must be made by a specialist using alternative approved regimens.

• Can Daklinza be taken with antacids or proton‑pump inhibitors?
  Yes. Daclatasvir’s absorption is not significantly affected by changes in gastric pH, so routine use of antacids, H2‑blockers, or proton‑pump inhibitors does not require dose adjustment.

• What does the Daklinza tablet look like?
  The tablet is a white, round, film‑coated tablet marked with the imprint “DK‑60”. It contains no coloured dyes, making it suitable for patients with dye sensitivities.

• Are there any special storage requirements for Daklinza?
  Store the tablets at controlled room temperature (15 °C–30 °C). Protect them from excessive moisture and direct sunlight; do not refrigerate or freeze.

• How long can a patient keep a supply of Daklinza after opening the bottle?
  Once the bottle is opened, the tablets remain stable for up to 24 months provided they are stored as described above and the original packaging is kept intact.

• Does Daklinza appear on standard drug‑testing panels for employment or sport?
  Daclatasvir is not a prohibited substance under World Anti‑Doping Agency (WADA) regulations and is not included in typical occupational drug‑screening panels.

• Can Daklinza be imported for personal use under UK law?
  Personal importation of a prescription‑only medicine is permitted in limited quantities (up to a 3‑month supply) when the patient holds a valid UK prescription. Importation without a prescription may breach customs regulations.

• What clinical trial established Daklinza’s efficacy?
  The Phase III HCV‑SIR (Sustained Virologic Response) studies demonstrated SVR12 rates of 94–99 % when Daklinza was combined with sofosbuvir in genotype 1, 2, 3, and 4 patients, including those with compensated cirrhosis.

• How does Daklinza compare with earlier interferon‑based regimens?
  Interferon‑based therapy required injections, prolonged treatment (48 weeks), and was associated with significant flu‑like symptoms and depression. Daklinza‑based oral regimens are shorter (12–24 weeks), have higher cure rates, and a markedly improved tolerability profile.

• Is there a difference between Daklinza tablets sold in the EU and those marketed in the US?
  The active ingredient, daclatasvir, is identical across regions. Minor formulation differences, such as excipient composition, may exist but do not affect clinical efficacy or safety.

• Can patients with hepatitis B co‑infection take Daklinza?
  Co‑infection with hepatitis B virus requires careful monitoring, as rapid HCV clearance can lead to hepatitis B reactivation. Patients should be evaluated for HBV DNA levels and may need antiviral prophylaxis.

• What is the impact of genetic polymorphisms on Daklinza efficacy?
  Certain NS5A resistance‑associated substitutions (RAS) can reduce daclatasvir potency. Baseline resistance testing is recommended for genotype 1a patients with prior DAA failure to guide optimal regimen selection.

Glossary

NS5A inhibitor

A class of antivirals that block the hepatitis C virus non‑structural protein 5A, preventing viral 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 virologic cure.

CYP3A4

A liver enzyme responsible for the metabolism of many drugs, including daclatasvir; inhibitors or inducers of this enzyme can alter drug levels.

Compensated cirrhosis

Advanced liver scarring where the liver still performs essential functions without overt failure; classified as Child‑Pugh A.

⚠️ Disclaimer

The information provided about Daklinza is for general knowledge only. It does not replace professional medical consultation. All treatment decisions should be made under the supervision of a qualified healthcare provider. We assume all readers are responsible adults capable of making informed decisions about their health. Our online pharmacy offers access to Daklinza for individuals who may have limited availability through traditional pharmacies, prescription‑based insurance schemes, or who are seeking affordable generic alternatives. Always consult your doctor before starting, changing, or discontinuing any medication.