Retrospective Study to Evaluate the Impact of Using Interferon (Pegylated or Not) in the Treatment of Patients With Chronic Hepatitis C in Brazil (DECISION)

NCT01280656 COMPLETED Results posted

This retrospective study will assess the sustained virologic response and the safety of two different interferons (pegylated or conventional) in patients with chronic hepatitis C. Data will be collected for 24 weeks.

Details

Lead sponsor	Hoffmann-La Roche
Status	COMPLETED
Enrolment	660
Start date	2010-01
Completion	2013-06

Conditions

• Hepatitis C, Chronic

Interventions

• Conventional Interferon
• Peginterferon Alfa-2a
• Peginterferon Alfa-2b
• Ribavirin

Primary outcomes

• Percentage of Participants With Sustained Virologic Response at 12 Weeks After End of Treatment — At Week 60
  Sustained virological response (SVR) was defined as virological response at 12 weeks after end of treatment (EOT). Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid \[HCV RNA\] was detected in the participants' plasma samples) or less than 50 international units/milliliter (IU/mL) HCV RNA (that is, the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). EOT= Week 48. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.

Countries

Brazil