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Ledipasvir/Sofosbuvir: A Review in Chronic Hepatitis C

Lesley J Scott1

  • 1Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. demail@springer.com.

Drugs
|January 31, 2018
PubMed

Insights

Ledipasvir/sofosbuvir (Harvoni®) offers high sustained virological response rates for chronic hepatitis C (CHC) in adults and adolescents. This direct-acting antiviral regimen is effective across various genotypes and patient populations, including those with cirrhosis or HIV co-infection.

Area of Science:

  • Hepatology
  • Virology
  • Pharmacology

Background:

  • Chronic hepatitis C (CHC) treatment has been revolutionized by direct-acting antiviral (DAA) regimens.
  • Ledipasvir/sofosbuvir (Harvoni®) is an approved, fixed-dose, once-daily oral treatment for CHC in adults and adolescents.

Purpose of the Study:

  • To evaluate the efficacy and tolerability of ledipasvir/sofosbuvir (± ribavirin) in diverse CHC patient populations.
  • To assess sustained virological response rates (SVR12) in treatment-naive and -experienced individuals.

Main Methods:

  • Analysis of clinical trial and real-world data for ledipasvir/sofosbuvir (± ribavirin) treatment.
  • Inclusion of patients with various hepatitis C virus (HCV) genotypes (GT1-6), cirrhosis, HIV co-infection, and post-transplant status.

Main Results:

  • High SVR12 rates were observed in adults and adolescents with HCV GT1 infection, including those with compensated cirrhosis or HIV co-infection.
  • Consistent SVR12 rates were reported in real-world studies compared to clinical trials.
  • High SVR12 rates were also achieved in patients with HCV GT2, 3, 4, 5, or 6 infection, cirrhosis, post-transplant status, and prior DAA/interferon treatment failure.

Conclusions:

  • Ledipasvir/sofosbuvir (± ribavirin) is an effective and well-tolerated option for adults and adolescents with HCV GT1, 4, 5, or 6 infection, including those with HIV co-infection or cirrhosis.
  • Evidence supports its use in patients with chronic HCV GT2 or 3 infection as well.

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