HTB

Schering’s pegylated interferon approved for treating hepatitis C in HIV coinfected patients

3 July 2007. Related: Hepatitis coinfection.

On 25 June 25, 2007, Schering-Plough announced that the European Commission has approved combination therapy with Pegintron (peginterferon alfa-2b, 1.5 mcg/kg once weekly) and Rebetol (ribavirin, 800 – 1,200 mg daily) for the treatment of previously untreated adult patients with chronic hepatitis C who are coinfected with clinically stable HIV.

The European Commission approval results in Marketing Authorization with unified labeling that is valid in the current European Union (EU) 27 member states as well as in Iceland and Norway.

Although already widely used in coinfected patients earlier EU approval in March 2001 was for treating adult patients with chronic hepatitis C alone.

Approval was based on the results of two published clinical studies in previously HCV untreated adult patients. [1, 2] Duration of treatment in HCV/HIV coinfected patients is 48 weeks, regardless of HCV genotype.

Comment

For approval in coinfected patients to come more than 5 years after the original indication highlights the delay that coinfected patients face in access to new treatments for hepatitis C, which was recognised in a recent EU concept paper. [3]

Source: Schering-Plough press release (06/25/07).
http://www.schering-plough.com

References:

  1. Carrat F, Bani-Sadir F, Pol S et al. JAMA 2004; 292(23): 2839-2848.
  2. Laguno M, Murillas J, Blanco J et al. AIDS 2004; 18(13): F27-F36.
  3. Concept paper for clinical development of medicinal products for the treatment of hepatitis C infection (26 April). Ref: EMEA/CHMP/EWP/156308/2007

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