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Sofosbuvir for chronic hepatitis C virus infection genotype 1-4 in patients coinfected with HIV

Maribel Rodriguez-Torres1, Anuj Gaggar, Gong Shen

  • 1*Fundacion de Investigacion, Santurce, Puerto Rico; †Gilead Sciences, Inc, Foster City, CA; and ‡University of Puerto Rico, San Juan, Puerto Rico.

Journal of Acquired Immune Deficiency Syndromes (1999)
|January 27, 2015
PubMed

Insights

Sofosbuvir is safe and effective for patients with chronic hepatitis C virus (HCV) and HIV coinfection. The drug showed no interactions with antiretrovirals and achieved high sustained virologic response rates when combined with peginterferon-ribavirin.

Area of Science:

  • Hepatology and Virology
  • Infectious Diseases
  • Antiviral Drug Development

Background:

  • Chronic hepatitis C virus (HCV) infection significantly increases morbidity and mortality in patients with HIV.
  • Sofosbuvir, an HCV NS5B inhibitor, demonstrates potent pan-genotypic antiviral activity.
  • Understanding drug interactions and treatment efficacy is crucial for managing HCV/HIV coinfection.

Purpose of the Study:

  • To assess the safety and efficacy of sofosbuvir in patients coinfected with HCV and HIV.
  • To evaluate potential drug interactions between sofosbuvir and various antiretroviral agents.
  • To determine the sustained virologic response rate of sofosbuvir-based therapy in HCV/HIV-coinfected individuals.

Main Methods:

  • A two-part study involving noncirrhotic patients with chronic HCV (genotypes 1-6) and stable HIV.
  • Part A: Open-label, multiple-dose study to assess drug interactions with common antiretrovirals.
  • Part B: Open-label, single-arm pilot study of sofosbuvir plus peginterferon-ribavirin for 12 weeks, with SVR12 as the primary endpoint.

Main Results:

  • No clinically significant drug interactions were observed between sofosbuvir and evaluated antiretrovirals in Part A.
  • In Part B, 91.3% of patients achieved sustained virologic response (SVR12).
  • No serious adverse events, HIV viral breakthrough, or CD4 count decreases were reported; two patients discontinued treatment due to adverse events.

Conclusions:

  • Sofosbuvir can be safely coadministered with commonly used antiretroviral therapies.
  • The combination of sofosbuvir with peginterferon-ribavirin demonstrated high efficacy for treating HCV/HIV-coinfected patients.
  • Sofosbuvir represents a promising therapeutic option for managing chronic HCV in the context of HIV coinfection.
Abstract

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