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PEGASYS

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Opinions on drugs - Posted on Mar 15 2006 - Updated on Feb 19 2009

Reason for request

Extension of indication in the treatment of HBeAg positive or negative chronichepatitis B in adults with compensated liver disease.Extension of indication in the treatment of chronic hepatitis C in adultscoinfected with HIV (stable HIV infection), who are serum HCV-RNA positive,including patients with compensated cirrhosis

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Clinical Benefit
Substantial

Treatment of HBeAg positive or negative chronic hepatitis B in adults with compensated liver disease
The actual benefit of Pegasys is substantial.


Treatment of HIV coinfected adult patients (stable HIV infection), with serum positive HCV RNA, including patients with compensated cirrhosis
The actual benefit of Pegasys in HIV-HCV coinfected patients is substantial.

Clinical Added Value
no clinical added value

- Patients with HBeAg positive or negative chronic hepatitis B, with compensated liver disease
The superiority of Pegasys over standard alpha interferons has not been satisfactorily proven. The Committee considered that Pegasys does not offer any improvement in actual benefit (IAB V) compared to standard alpha interferon.

- Patients with chronic hepatitis C
Changes in the SPC relating to the treatment of adult patients coinfected with HCV and HIV (stable HIV infection) do not justify changing the previous Opinion (Committee Opinion of 20 November 2002).

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