Safety of peginterferon alfa-2a plus ribavirin in a large multinational cohort of chronic hepatitis C patients

Liver International, 08/21/2012

The study confirmed the safety and tolerability profile of peginterferon alfa–2aribavirin and identified patient subgroups at higher risk of dose reductions and discontinuations, thus allowing optimum management of adverse events (AEs).

Methods

  • Patients were assigned at the investigator's discretion to 24- or 48-week treatment with peginterferon alfa-2a 180 μg/week and ribavirin 800 mg/day or 1000/1200 mg/day.
  • All AEs, defined as SAEs and non-SAEs of special interest, were recorded during treatment and for 12 weeks thereafter.
  • Non-SAEs of special interest included those leading to dose reduction/discontinuation, neutropenia, thrombocytopenia, anaemia, ALT elevations leading to dose modification and unknown/unexpected AEs.

Results

  • Of 1675 and 7178 patients assigned to 24 and 48 weeks of treatment, respectively, 87.6 and 68.3% completed therapy, whereas 6.4 and 10.3% prematurely stopped peginterferon alfa-2a treatment because of AEs.
  • Among patients assigned to 24 and 48 weeks, 37.4 and 46.9%, respectively, reported any AE (SAE or non-SAE of special interest); 4.2 and 6.6% reported SAEs and 35.2 and 44.0% reported non-SAEs of special interest.
  • Female gender, increasing age and cirrhosis were significantly associated with dose reductions of either drug.
  • Increasing age (and female gender in the case of ribavirin) was significantly associated with treatment discontinuation.

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