Trial Outcomes & Findings for Pharmacoeconomic Study Assessing the Cost of Chronic Hepatitis C Treatment With Peginterferon Alfa-2b (PegIntron) and Ribavirin (Rebetol) in the Czech Republic (Study P04588)(COMPLETED) (NCT NCT00723632)

Results Overview

SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.

Recruitment status

COMPLETED

Target enrollment

901 participants

Primary outcome timeframe

From enrollment up to 48 weeks for participants with hepatitis C virus (HCV) genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3

Results posted on

2015-10-02

Participant Flow

Participant milestones

Participant milestones
Measure	Peginterferon Alfa-2b and Ribavirin Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants \<65 kg, 1000 mg/day for participants \>65 to \<85 kg, and 1200 mg/day for participants \>=85 kg. Treatment was administered for 48 weeks to participants with hepatitis C virus (HCV) genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
Overall Study STARTED	901
Overall Study COMPLETED	698
Overall Study NOT COMPLETED	203

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacoeconomic Study Assessing the Cost of Chronic Hepatitis C Treatment With Peginterferon Alfa-2b (PegIntron) and Ribavirin (Rebetol) in the Czech Republic (Study P04588)(COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peginterferon Alfa-2b and Ribavirin n=698 Participants Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants \<65 kg, 1000 mg/day for participants \>65 to \<85 kg, and 1200 mg/day for participants \>=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
Age, Continuous	38 years n=5 Participants
Sex: Female, Male Female	300 Participants n=5 Participants
Sex: Female, Male Male	398 Participants n=5 Participants

PRIMARY outcome

Timeframe: From enrollment up to 48 weeks for participants with hepatitis C virus (HCV) genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3

Population: Participants were included in the analysis if all of the following conditions were met: initial exam form was completed; at least 1 follow up visit form was completed; the end of treatment (either according to plan or early) was recorded; and SVR status was recorded six months after treatment termination.

SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2b and Ribavirin n=698 Participants Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants \<65 kg, 1000 mg/day for participants \>65 to \<85 kg, and 1200 mg/day for participants \>=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
Average Cost Per Participant With Sustained Virologic Response (SVR) Stratified by Weight Category <= 64 kg (n=182)	28,271 Czech Crown
Average Cost Per Participant With Sustained Virologic Response (SVR) Stratified by Weight Category 65-85 kg (n=334)	31,429 Czech Crown
Average Cost Per Participant With Sustained Virologic Response (SVR) Stratified by Weight Category >= 85 kg (n=182)	34,782 Czech Crown

SECONDARY outcome

Timeframe: From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3

Population: Participants were included in the analysis if all of the following conditions were met: initial exam form was completed; at least 1 follow up visit form was completed; the end of treatment (either according to plan or early) was recorded; and SVR status was recorded six months after treatment termination.

SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2b and Ribavirin n=698 Participants Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants \<65 kg, 1000 mg/day for participants \>65 to \<85 kg, and 1200 mg/day for participants \>=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
Average Cost Per Participant With SVR Stratified by Ribavirin Dosage 800 mg/day (n=167)	31,119 Czech Crown
Average Cost Per Participant With SVR Stratified by Ribavirin Dosage 1000 mg/day (n=333)	29,306 Czech Crown
Average Cost Per Participant With SVR Stratified by Ribavirin Dosage 1200 mg/day (n=198)	35,621 Czech Crown

SECONDARY outcome

Timeframe: From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3

Population: Participants were included in the analysis if all of the following conditions were met: initial exam form was completed; at least 1 follow up visit form was completed; the end of treatment (either according to plan or early) was recorded; and SVR status was recorded six months after treatment termination.

SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2b and Ribavirin n=698 Participants Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants \<65 kg, 1000 mg/day for participants \>65 to \<85 kg, and 1200 mg/day for participants \>=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
Average Cost Per Participant With SVR Stratified by Prior Treatment Status Treatment-Naive (n=543)	30,109 Czech Crown
Average Cost Per Participant With SVR Stratified by Prior Treatment Status Previously Treated (n=155)	37,486 Czech Crown

Adverse Events

Peginterferon Alfa-2b and Ribavirin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place