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Daclatasvir

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Daclatasvir

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Daclatasvir

Daclatasvir is a modern, synthetic medicine used as a crucial component in treating chronic Hepatitis C Virus (HCV) infection. It is a highly targeted drug that works directly against the virus itself.

Property Description
Active ingredient Daclatasvir (as dihydrochloride salt)
Form Film-coated tablet (Oral)
Pharmacological class Direct-Acting Antiviral Agent (DAA)
HCV Mechanism NS5A Replication Complex Inhibitor
Origin Synthetic (chemically synthesized)
Prescription Status Prescription-only (Rx)

What Type of Medicine is Daclatasvir and How is it Classified?

Daclatasvir is a synthetic chemical substance classified as a potent Direct-Acting Antiviral Agent (DAA) that targets the Hepatitis C Virus (HCV). Specifically, it is a HCV NS5A Inhibitor, which means it blocks a critical protein (NS5A) the virus needs to multiply and spread. Pharmacological studies have consistently supported Daclatasvir's unique position as a benchmark pangenotypic NS5A inhibitor among DAAs, highlighting its broad effectiveness against multiple HCV genotypes. This highly selective action is vital because it offers a direct way to interrupt the viral life cycle, unlike older, less targeted treatments.

Daclatasvir Composition and General Therapeutic Purpose

The medicine is supplied for oral use as a film-coated tablet and contains only Daclatasvir as the active ingredient, formulated as the daclatasvir dihydrochloride salt. Although Daclatasvir is a single active ingredient product, it is mandated for use exclusively within a combination therapy strategy, never as a monotherapy. The overall purpose of Daclatasvir is to serve as a foundational, high-efficacy component in the modern treatment of chronic HCV infection. The drug's function is to significantly lower the amount of circulating Hepatitis C Virus in the body, which is essential for reaching the ultimate clinical goal of viral clearance and mitigating the long-term risk of severe liver disease.

Regulatory References

  1. Daclatasvir NS5A Inhibitor Review

What side effects are possible with Daclatasvir?

Possible Side Effects and Safety Information

The regulatory safety profile for Daclatasvir, which is used only in combination therapy for chronic Hepatitis C Virus (HCV) infection, is structured by classifying documented adverse reactions based on their frequency and the body systems affected. This framework is consistent with standards established by health authorities like the FDA and EMA.

Adverse Reaction Classification

Side effects are categorized based on their observed occurrence in clinical trials:

  • Very Common (ge 1/10): Includes general systemic effects such as fatigue and headache.
  • Common (ge 1/100 to < 1/10): Reactions affecting various systems, including nausea, diarrhea, insomnia, and anaemia.

These effects are formally grouped into System-Organ Classes, such as Nervous System Disorders and Gastrointestinal Disorders, according to official regulatory labeling.

Serious Adverse Reactions and Restrictions

Official labels document a significant safety warning related to specific combination use. Symptomatic bradycardia (slowed heart rate) is a documented serious risk, especially when Daclatasvir is co-administered with Sofosbuvir and the antiarrhythmic drug Amiodarone.

Its use is subject to an absolute contraindication against certain medicines: strong inducers of the CYP3A enzyme (e.g., rifampicin, phenytoin, St. John’s Wort). This restriction is in place because co-administration substantially reduces Daclatasvir levels, risking a loss of viral clearance.

Population-Specific Notes

Safety considerations are highlighted for specific groups. Patients with decompensated cirrhosis (advanced liver disease) are noted to have a higher potential for serious adverse events during combination therapy. Safety and efficacy have been established for patients with severe renal impairment or End-Stage Renal Disease (ESRD).

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documents state that no specific clinical signs or characteristic symptoms are officially documented for an overdose of Daclatasvir when the drug is administered as a single agent. Treatment of overdose is universally mandated to consist of general supportive measures, including the monitoring of vital signs and observation of the patient's clinical status under medical supervision.

A critical, life-threatening risk specifically documented in official labeling is the potential for severe symptomatic bradycardia (abnormally slow heart rate) and heart block when Daclatasvir is used in certain combination regimens, particularly those involving sofosbuvir and amiodarone. Such severe cardiovascular events have, in some cases, required pacemaker intervention. It is also noted that no specific antidote is known, and due to the drug's high protein binding, dialysis is unlikely to remove substantial amounts.

When Immediate Medical Help is Required

Patients must seek immediate medical evaluation or medical advice urgently upon experiencing any symptoms related to these severe cardiac effects. These required help-seeking triggers include: fainting or near-fainting, dizziness or lightheadedness, shortness of breath, or chest pain. The overall regulatory profile dictates urgent medical action for these specific, documented, life-threatening outcomes.

Therapeutic Uses of Daclatasvir

Daclatasvir is an antiviral medicine that targets the chronic viral presence, commonly used as a core component in the modern management of chronic Hepatitis C Virus (HCV) infection. Its therapeutic goal is not to relieve immediate, acute symptoms, but to address the underlying condition and help manage the risks associated with long-term disease progression. It is indicated for use in combination therapy for chronic HCV infection.

Managing Chronic Viral Presence (Pangenotypic Efficacy)

Daclatasvir is applied across regimens designed to treat all major global types of the virus, including Genotypes 1, 3, and 4. This use is relevant for achieving Sustained Virological Response (SVR), a primary therapeutic benefit that is associated with a sustained reduction of the chronic viral load to undetectable levels, which is the clinical measure of treatment success.

“The treatment approach is centered on addressing the viral presence, which supports the goal of long-term health maintenance.”

Supporting the Interruption of Liver Disease Progression

The medication is used to address the ongoing inflammation and scarring in the liver tissue, such as fibrosis and cirrhosis (both compensated and decompensated), which are consequences of chronic HCV. By addressing the viral activity, the treatment supports the interruption of the progression of liver damage, which may assist in easing the overall risk of severe liver conditions. The drug is also relevant in challenging clinical contexts, including patients with HCV recurrence after a liver transplant or HCV/HIV co-infection.

Key Use: Addressing Chronic Viral Presence

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Daclatasvir

Populations for whom use is allowed (as stated in label):

  • Adults aged 18 years and older.
  • Patients with Compensated or Decompensated Cirrhosis.
  • Patients with HCV/HIV-1 coinfection or post-liver transplant HCV recurrence.

Populations for whom use is contraindicated:

  • Patients with a history of Hypersensitivity to the active substance or excipients.
  • Patients co-administering Strong CYP3A4 Inducers (e.g., Rifampicin, Carbamazepine, Phenytoin, or St. John's Wort) due to the risk of lower exposure and loss of efficacy.

Age and Condition-specific Eligibility Rules:

  • Paediatric Population (Under 18): Use is not established and not recommended.
  • Organ Impairment: No dose adjustment is required for any degree of hepatic or renal impairment.
  • Pregnancy: Use is contraindicated in women of childbearing potential not using effective contraception; if combined with Ribavirin, the Ribavirin pregnancy avoidance rules apply to the entire regimen.
  • Restrictions: All patients must be tested for HBV infection prior to treatment, and co-infected patients must be monitored for HBV reactivation.

What should I know about interactions with other medicines?

Daclatasvir's official interaction profile is defined by its role as a substrate of the metabolic enzyme CYP3A4 and the efflux transporter P-glycoprotein (P-gp). Co-administration with medicines that modify these pathways can significantly alter daclatasvir's concentration in the body.

Contraindicated Combinations

The regulatory label specifies that co-administration with strong CYP3A inducers is formally contraindicated. This includes medicines such as rifampin, phenytoin, and the herbal product St. John’s wort (Hypericum perforatum). These substances severely reduce daclatasvir plasma levels, leading to a potential loss of virologic efficacy.

Pharmacokinetic and Transporter Interactions

To manage altered plasma exposure, mandatory dose adjustments are required when daclatasvir is co-administered with other CYP3A modulators. Furthermore, daclatasvir acts as an inhibitor of multiple drug transporters, including P-gp, OATP1B1/1B3, and BCRP, which may lead to increased systemic exposure of co-administered medicines that are substrates of these transporters.

Other Documented Interactions

The combination of daclatasvir and sofosbuvir with amiodarone is not recommended due to a documented risk of severe symptomatic bradycardia. Administration with a high-fat, high-calorie meal is documented to reduce daclatasvir exposure. Regulatory guidance also notes that diabetic patients should have their glucose levels closely monitored upon initiation of daclatasvir therapy.

Mechanism of Action

Daclatasvir is a highly selective direct-acting antiviral (DAA) that binds to the Non-structural protein 5A (NS5A), a protein essential for the Hepatitis C Virus (HCV) life cycle. This binding action immediately neutralizes two distinct functions of NS5A: preventing the formation of the viral RNA replication complex and disrupting the pathway necessary for virion assembly and secretion. This dual molecular blockade limits the ability of the virus to copy its genome or package new infectious particles.

The simultaneous inhibition of both viral replication and assembly establishes a comprehensive mechanistic cascade that leads to the drug's primary physiological effect. This action results in a rapid reduction in the amount of circulating HCV RNA (viral load) within the body. When Daclatasvir's mechanism is complemented by combination with other DAAs, it establishes a high genetic barrier to resistance, which is the physiological constraint required for the sustained suppression of the viral population.

Dosage and Administration Information

How to Use Daclatasvir

Daclatasvir is administered exclusively by the oral route as a film-coated tablet. It is a core component of combination therapy, meaning it is never used alone but always with other specified antiviral agents.

Official Administration and Dosage

Administration is structured around a once-daily (QD) schedule, and the tablet can be taken with or without food. For proper use, the film-coated tablet must be swallowed whole and should not be crushed, chewed, or broken.

Usage Parameter Parameter Details
Standard Daily Dose 60 mg once daily.
Dose for Strong CYP3A Inhibitors Reduce dose to 30 mg once daily.
Dose for Moderate CYP3A Inducers Increase dose to 90 mg once daily.
Typical Duration 12 weeks in most combination regimens.

Population and Procedural Rules

Standard procedures are used for managing treatment. If a dose is missed and less than 20 hours have passed since the usual time, the dose should be taken immediately; otherwise, the missed dose is skipped, and the next dose is taken at the regularly scheduled time. Critically, the standard 60 mg dose is maintained without adjustment for patients with any degree of renal impairment or hepatic impairment (Child-Pugh A, B, or C). No dosing recommendation is established for pediatric patients under 18 years old.

Recent Clinical Evidence

Daclatasvir: Recent Clinical Evidence

This section summarizes the published clinical research and regulatory trials that investigated the drug’s observed effects and safety characteristics. Daclatasvir is a direct-acting antiviral (DAA) approved for the treatment of chronic Hepatitis C virus (HCV) infection, typically used in combination with other DAAs like sofosbuvir.

Phase I-II: Initial Investigations

Early-stage research focused on the compound’s pharmacodynamics. Initial studies investigated the compound's effect on the viral load in controlled settings. Initial findings demonstrated a statistically significant change in viral RNA levels compared to placebo in treatment-naive and treatment-experienced patients. Tolerability trials examined the treatment in adult populations, with the profile detailed in the full safety data published in the trial reports.

Phase III: Efficacy and Long-Term Outcomes

Large-scale Phase III trials were conducted globally, primarily evaluating the drug's effect on achieving sustained virologic response (SVR)—the absence of detectable HCV RNA 12 weeks after completing therapy (SVR12).

  • Trial X (Genotype 3 Monotherapy): This pivotal trial randomized patients to receive a daclatasvir-containing regimen. This study reported high rates of SVR12 in patients with genotype 3 infection when compared to previous standard-of-care treatments.
  • Trial Y (Combination Therapy): A separate study evaluated the efficacy across multiple HCV genotypes (1, 2, 3, and 4) when daclatasvir was administered alongside sofosbuvir. Research demonstrated high SVR rates, indicating the broad effectiveness of the combination regimen.

Safety and Adverse Events

Research has examined the outcomes of co-administration with certain cardiac medications, noting the potential for drug-drug interactions. The long-term study indicated the compound was examined for its effect on preventing viral relapse over a follow-up period; trial reports indicated that no new safety signals were observed in the study cohort during this time.

Important Note on Interpretation:

The information presented here is a summary of research findings. It is not intended as medical guidance or advice. The decision to use any medication requires a comprehensive assessment of individual patient factors and risks. Individuals are advised to consult their healthcare provider to discuss the suitability of this or any other treatment.

Key Studies & References

  1. Hepatitis C Guidance 2023 Update: American Association for the Study of Liver Diseases–Infectious Diseases Society of America Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection
  2. EASL Recommendations on Treatment of Hepatitis C 2018

Frequently Asked Questions (FAQ)

Common questions about Daclatasvir (FAQ)

Q: How quickly does Daclatasvir start working?

Studies and official information indicate that Daclatasvir's concentration in the body reaches its highest level approximately two hours after a dose. The drug's mechanism of action is associated with a rapid initial reduction in the amount of circulating Hepatitis C Virus (HCV) in the body, as observed in studies.

Q: Can Daclatasvir affect my heart rate?

Official warnings note a specific, serious risk to heart rate. When Daclatasvir is used in combination with Sofosbuvir and the heart medication Amiodarone, there is a documented risk of severe symptomatic bradycardia (slowed heart rate) and heart block. The official warning indicates that monitoring may be required when this specific combination of medications is administered.

Q: Is it possible for Daclatasvir to interact with birth control pills?

The official product information requires women of childbearing potential to use highly effective contraception during treatment and for five weeks afterward. Additionally, Daclatasvir can affect drug transporters in the body, which could potentially alter the concentration of co-administered medicines that share these pathways.

Q: Can women who are pregnant use Daclatasvir?

Official documents state that the use of Daclatasvir is generally contraindicated during pregnancy, and its use is not recommended for women of childbearing potential who are not using effective contraception.

Q: Can Daclatasvir interact with herbal remedies?

The regulatory label strictly contraindicates co-administration with the herbal product St. John’s wort (Hypericum perforatum), as this substance can severely reduce the level of Daclatasvir in the blood, which may compromise treatment effectiveness.

Q: Why does the packaging for Daclatasvir have a Black Box Warning?

Daclatasvir, like other direct-acting antiviral (DAA) medicines for Hepatitis C, carries the FDA's most serious safety warning, often called a Black Box Warning. This warning highlights the risk of Hepatitis B Virus (HBV) reactivation in patients who are co-infected with HBV and HCV.

Q: Does Daclatasvir interact with medications for depression or anxiety?

Daclatasvir is processed in the body by the CYP3A4 enzyme, a pathway that certain medications for depression or anxiety may also affect. Furthermore, the official label lists psychiatric adverse reactions, such as insomnia and anxiety, as common effects observed during combination therapy.

Q: Does Daclatasvir cure the condition it treats?

Regulatory trials define treatment success by achieving a Sustained Virologic Response (SVR), meaning the virus is undetectable in the blood 12 weeks after finishing therapy. Achieving SVR is the defined clinical goal and is associated with significant, long-term health benefits.

Q: Is Daclatasvir a chemotherapy drug?

No, Daclatasvir is officially classified as a Direct-Acting Antiviral Agent (DAA). It is an HCV NS5A inhibitor designed to specifically block a protein the Hepatitis C Virus needs to multiply, which is a different mechanism from traditional chemotherapy drugs.

Q: What should I know about drug resistance with Daclatasvir?

Regulatory information notes that if treatment is not effective, the virus can develop resistance. Daclatasvir's use in combination regimens is designed to achieve a high genetic barrier to resistance, which is the physiological constraint required to help prevent the virus from evolving.

Q: Is it common to feel tired while taking Daclatasvir?

Yes, fatigue (tiredness) is classified in official documents as a Very Common side effect. This categorization indicates it is one of the most frequently observed effects when Daclatasvir is used as part of a combination therapy.

Q: Can Daclatasvir cause a headache?

Yes, headache is also classified in official documents as a Very Common side effect. It is one of the most frequently reported effects when the medicine is used in combination therapy.

Q: Are there any serious side effects associated with Daclatasvir?

The regulatory label documents serious risks, including the severe slowed heart rate (symptomatic bradycardia) when combined with specific cardiac drugs. There is also a risk of Hepatitis B Virus (HBV) reactivation in patients who have both HBV and HCV.

Q: Does Daclatasvir have an effect on kidney function?

Official labeling states that no dose adjustment for Daclatasvir is required for patients with any degree of renal impairment or End-Stage Renal Disease (ESRD). This is an indication that the medicine is generally well-tolerated in patients with existing kidney issues.

Q: Are there any food restrictions when taking Daclatasvir?

Daclatasvir may be taken with or without food. However, official product information notes that administration with a high-fat, high-calorie meal can reduce the amount of the drug absorbed into the body.

Q: What is the experience of people who have taken Daclatasvir?

Clinical trials reported high rates of Sustained Virologic Response (SVR) across multiple genotypes, which indicates the treatment's success in clearing the virus. The safety profile reviewed in trials identified the most common adverse effects as headache and fatigue.

Q: Are there any known long-term side effects of Daclatasvir?

Long-term follow-up of patients who participated in clinical trials indicated that no new safety signals were observed in the study cohorts after the completion of therapy. The primary long-term benefits are associated with achieving sustained viral clearance (SVR).

Q: Is there a generic version of Daclatasvir available?

The original branded product has been discontinued. Official records indicate that multiple patents related to the drug substance and methods of use are in effect, and its availability depends on the regulatory status in specific regions.

Q: Does Daclatasvir require combination with ribavirin?

Daclatasvir is always used in combination with other antiviral agents. For certain patient populations, particularly those with decompensated cirrhosis, the combination regimen may include the medicine ribavirin.

Q: What are the main research conclusions about Daclatasvir's effectiveness?

Research conclusions support that Daclatasvir, when used in combination therapy, is highly effective across multiple HCV genotypes. The trials demonstrated that the treatment led to high rates of Sustained Virologic Response (SVR), the ultimate goal of HCV therapy.

Q: Is it normal to have a slight fever when starting Daclatasvir?

Official documents list pyrexia (fever) as a potential effect in some combination regimens. It is typically categorized as a Common side effect in certain combination therapies, meaning it occurs in more than 1 in 100 patients.

Q: What happens when treatment with Daclatasvir is stopped?

Discontinuation of therapy before the scheduled end date may limit the overall health benefits associated with viral clearance. Stopping treatment prematurely also carries a risk of the Hepatitis C Virus developing resistance to future treatments.

Q: Is Daclatasvir used to treat other viral infections?

Daclatasvir is a highly specific Direct-Acting Antiviral designed to target the Hepatitis C Virus (HCV). It is not indicated or effective for treating other viral infections, such as the common cold or influenza.

Q: Is it possible to be allergic to Daclatasvir?

Yes, the official label lists hypersensitivity to the active substance or any component of the formulation as a contraindication. This means the medicine must not be used by patients who have had an allergic reaction to it in the past.

Q: Does Daclatasvir need to be taken with a meal?

Daclatasvir may be taken with or without food. However, official information notes that a high-fat, high-calorie meal can reduce the amount of the drug that gets into the bloodstream.

Q: How effective is Daclatasvir in real-world studies?

The drug's approved effectiveness is based on clinical trials which reported high rates of Sustained Virologic Response (SVR). Real-world evidence remains a subject of ongoing regulatory interest to confirm effectiveness across broader, more diverse patient populations outside of controlled study settings.

Q: Is blood work required before starting Daclatasvir?

Official regulatory information mandates that all patients must be tested for Hepatitis B Virus (HBV) infection prior to initiating Daclatasvir treatment. This testing is mandated in regulatory documents due to the documented risk of HBV reactivation associated with the treatment.

Q: What is the role of Daclatasvir in different genotypes of the infection?

Daclatasvir is approved for use against specific Hepatitis C Virus genotypes, including genotype 1 and genotype 3 infections, when used in combination with other agents. It is recognized in studies for its pangenotypic (broad) inhibitory properties.

How should Daclatasvir be stored and disposed of?

Storage and Disposal of Daclatasvir

Daclatasvir tablets must be stored according to regulatory requirements to maintain product integrity and safety.

Storage Conditions

Constraint Requirement
Temperature Store at room temperature (below 30 C).
Environment Protect from excess heat, moisture, and direct light; Do not freeze.
Container Keep in the original container and ensure it is tightly closed.

All medication must be stored out of the reach of children in a secure location.

Disposal

Dispose of unused or expired Daclatasvir tablets safely. The preferred method is using a formal drug take-back program. Do not flush down the toilet or pour into a drain. If disposing in household trash, mix the tablets with an undesirable substance (e.g., dirt) and place the mixture in a sealed container.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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