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Simeprevir And Sofosbuvir

Simeprevir And Sofosbuvir

Introduction

Antiviral therapy for recurrent hepatitis C in liver transplant recipients has been associated with low efficacy, poor tolerability, and drug-drug interactions. Recent approval of various hepatitis C direct-acting antivirals has resulted in improvement of these parameters. We evaluated the efficacy and safety of 12 week all-oral interferon- and ribavirin-free therapy with sofosbuvir and simeprevir.

Class and mechanism

Simeprevir (Olysio) is a NS3/4A hepatitis C virus (HCV) protease inhibitor. Simeprevir is a macrocyclic compound that non-covalently binds to and inhibits the NS3/4A HCV protease, a protein that is responsible for cleaving and processing the HCV-encoded polyprotein, a critical step in HCV viral life cycle. Simeprevir is considered a second generation HCV protease inhibitor because of the enhanced binding affinity and specificity to NS3/4A when compared with the first-generation protease inhibitors with linear structure. 

Side effects and complications

Adverse effect is the term used for describing a symptom and/or abnormal lab result and complication that occurs during a clinical trial. This term encompasses at least the following scenarios:

  • medication-related side effects
  • complications that may be due to the disease process being studied (for example, an effect of chronic HCV infection) that may have nothing to do with the study drugs
  • accidents (these may also be unrelated to the study drugs)

In Target, participants who received peginterferon were more likely to report symptoms of a flu-like illness as well as depression, difficulty falling asleep, rash and fatigue. Such symptoms are common with exposure to peginterferon.

In general, the regimen with the fewest side effects was the combination of simeprevir + sofosbuvir.

Key points

According to the interim data from Target:

  • All regimens are broadly effective.
  • There were low rates of treatment failure.
  • There were low rates of treatment discontinuation.
  • There were fewer side effects from all-oral regimens than there are with interferon-containing regimens.
  • Side effects were lowest with the simeprevir + sofosbuvir regimen, as it did not contain interferon or ribavirin.

Sofosbuvir: Nucleotide analog polymerase inhibitor

Sofosbuvir, which blocks a specific protein needed by the hepatitis C virus to replicate, is to be used as a component of a combination antiviral treatment regimen for chronic HCV infection. It is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon. Depending on the type of HCV infection a patient has, the treatment regimen could include sofosbuvir and ribavirin or sofosbuvir, ribavirin, and peginterferon-alfa.

Safety and efficacy. Sofosbuvir's effectiveness was evaluated in six clinical trials consisting of 1,947 treatment-naive and treatment-experienced participants with HCV genotypes 1, 2, 3, or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those coinfected with HCV and HIV-1.

The trials were designed to measure whether HCV was no longer detected in the blood at least 12 weeks after finishing treatment, suggesting a participant's HCV infection has been cured.

Results from all clinical trials showed that a treatment regimen containing sofosbuvir was effective in treating multiple types of HCV. In addition, sofosbuvir demonstrated efficacy in participants who could not tolerate or take an interferon-based treatment regimen and in participants with liver cancer awaiting liver transplantation, addressing unmet medical needs in these populations.

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