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Related Concept Videos

Effect of Hepatic Disease on Pharmacokinetics: Dose Adjustments Due to Hepatic Impairment01:08

Effect of Hepatic Disease on Pharmacokinetics: Dose Adjustments Due to Hepatic Impairment

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Hepatic impairment, characterized by decreased liver function, does not uniformly mandate adjustments in drug dosage. Whether dosage modifications are necessary depends on various factors related to the drug's metabolism and elimination pathways. If a drug is primarily excreted via the kidneys and bypasses significant hepatic processing, if it undergoes minimal metabolic transformation in the liver, or if it is volatile and primarily expelled through the lungs, dose adjustments may not be...
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Effect of Hepatic Disease on Pharmacokinetics: Drug Dosing and Hepatic Blood Flow01:26

Effect of Hepatic Disease on Pharmacokinetics: Drug Dosing and Hepatic Blood Flow

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Chronic liver disease significantly impacts drug metabolism due to alterations in hepatic blood flow and enzyme accessibility. This disruption affects the body's pharmacokinetics—the movement and processing of drugs within the system. Key enzymes crucial for metabolizing medications become less accessible, changing how drugs are processed and utilized. Furthermore, liver disease influences the synthesis of plasma proteins, such as albumin and globulins, which play critical roles in drug...
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Effect of Hepatic Disease on Pharmacokinetics: Pathophysiologic Assessment and Liver Function Test01:22

Effect of Hepatic Disease on Pharmacokinetics: Pathophysiologic Assessment and Liver Function Test

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In clinical practice, the direct measurement of hepatic blood flow to evaluate liver function presents significant challenges due to the intricate and specialized nature of the necessary techniques. Consequently, healthcare professionals often rely on empirical estimates derived from thorough patient examinations and liver function tests to gauge liver health. Among the tools at their disposal, the Child–Pugh and MELD scoring systems stand out for their ability to categorize and assess...
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Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

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Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
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Effect of Hepatic Disease on Pharmacokinetics: Active Drug, Metabolite and Fraction of Metabolized Drug01:14

Effect of Hepatic Disease on Pharmacokinetics: Active Drug, Metabolite and Fraction of Metabolized Drug

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In pharmacotherapy, monitoring drug concentrations is paramount, especially for drugs whose therapeutic effects hinge on both the active compound and its metabolite. Hepatic impairment profoundly influences drug potency by altering liver function. If the drug is more potent than its metabolite, impaired liver function amplifies drug activity due to elevated drug concentration levels. Conversely, if the metabolite holds greater potency, diminished liver function diminishes drug activity by...
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Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

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The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each...
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Hepatitis C: How Good Are Real-Life Data and Do Generics Work.

Ashley N Tran1, Joseph K Lim2

  • 1Section of Digestive Diseases, Yale Liver Center, Yale University School of Medicine, New Haven, CT, USA.

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Summary

New oral direct-acting antivirals offer high cure rates for chronic hepatitis C virus infection. Real-world data show promising outcomes, but further studies are needed for challenging patient groups.

Keywords:
Antiviral therapyDirect-acting antiviralsDrug therapyGenericsHepatitis CReal-world cohorts

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Area of Science:

  • Hepatology
  • Infectious Diseases
  • Public Health

Background:

  • Chronic hepatitis C virus (HCV) infection is a major global health concern.
  • HCV infection leads to significant illness and death.
  • Oral direct-acting antiviral (DAA) therapies demonstrate high efficacy and tolerability.

Purpose of the Study:

  • To review real-world data on oral DAA regimens for chronic hepatitis C.
  • To assess the translation of trial efficacy to community settings.
  • To examine preliminary data on generic DAA formulations.

Main Methods:

  • Review of key datasets from major real-world observational cohort studies.
  • Analysis of preliminary data from oral generic DAA formulations.
  • Synthesis of current evidence on DAA treatment outcomes.

Main Results:

  • Oral DAA regimens achieve sustained virologic response (SVR) rates exceeding 90% in clinical trials.
  • Real-world SVR rates may differ from trial data, particularly with older regimens.
  • Generic DAA formulations show potential for improved accessibility.

Conclusions:

  • Sustained virologic response significantly improves clinical outcomes in patients with chronic hepatitis C.
  • Real-world effectiveness of DAAs needs continued evaluation.
  • Further research is essential to optimize treatment strategies for difficult-to-treat populations.