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Chou R, Hartung D, Rahman B, et al. Treatment for Hepatitis C Virus Infection in Adults [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Nov. (Comparative Effectiveness Reviews, No. 76.)
| Author, Year Country Quality | Comparison Definition of Sustained Virologic Response | Population Characteristics | Treatments | Results (by clinical outcome) |
|---|---|---|---|---|
| Arora, 20061 Australia, Europe, New Zealand, North America, and South America Quality: Poor | SVR vs. no SVR SVR=No detectable HCV RNA at end of followup (72 weeks) | Not reported by SVR status Mean age: 43 years Female: 60% Race: Non-white: 14% Advanced fibrosis: 10% Genotype 1: 68% Viral load: 1.1–1.2 × 106 copies/ml IVDU: 30% HIV positive: excluded | Pegylated interferon alfa-2a (24 or 48 weeks) | SVR vs. no SVR, mean difference in change from baseline SF-36 physical function: +4.7 (p<0.05) SF-36 role limitations-physical: +13 (p<0.05) SF-36 bodily pain: +11 (p<0.0001) SF-36 general health: +10 (p<0.0001) SF-36 vitality: +9.3 (p<0.0001) SF-36 social function: +5.1 (p>0.05) SF-36 role limitations-emotional: +7.3 (p>0.05) SF-36 mental health: +3.1 (p>0.05) SF-36 physical component summary: +4.9 (p<0.0001) SF-36 mental component summary: +2.0 (p>0.05) Fatigue Severity Scale, total score: −4.4 (p<0.01) Fatigue Severity Scale, VAS: −10 (p<0.01) |
| Bernstein, 20022 Australia, North America, Europe, Taiwan, New Zealand Quality: Poor | SVR vs. no SVR SVR=No detectable HCV RNA 24 weeks after completion of antiviral therapy | Not reported by SVR status Mean age <=40 years: 41% Female: 32% Race: Non-white: 14% Cirrhosis: 32% Genotype, viral load, HIV infection, IV drug use not reported | Pegylated interferon alfa-2a or interferon alfa-2a | SVR vs. no SVR, mean difference in change from baseline SF-36 physical function: +4.6 (p<0.001) SF-36 role limitations-physical: +9.8 (p<0.001) SF-36 bodily pain: +2.9 (p<0.01) SF-36 general health: +9.1 (p<0.001) SF-36 vitality: +9.6 (p<0.001) SF-36 social function: +6.2 (p<0.001) SF-36 role limitations-emotional: +8.4 (p<0.01) SF-36 mental health: +4.6 (p<0.001) SF-36 physical component summary: +2.8 (p<0.001) SF-36 mental component summary: +3.0 (p<0.001) Fatigue Severity Scale, total score: −0.5 (p<0.001) Fatigue Severity Scale, VAS: −11.5 (p<0.001) |
| Bini, 20063 USA Quality: Poor | SVR vs. no SVR SVR=No detectable HCV RNA 24 weeks after completion of antiviral therapy | Normal ALT and elevated ALT groups, respectively (not reported by SVR status) Mean age: 50 and 49 years Female: 11% and 8% Race: Non-white: 59% and 66% Normal ALT and elevated ALT groups, respectively (not reported by SVR status) Cirrhosis: 11% and 11% Genotype 1: 78% and 78% Viral load >2 × 106 copies/ml: 44% and 44% IVDU: 67% and 65% HIV positive: excluded | Interferon alfa-2b + ribavirin | SVR vs. no SVR, mean difference in change from baseline (normal ALT and elevated ALT subgroups, respectively; p values not reported) SF-36 physical function: +18 and +15 SF-36 role limitations-physical: +22 and +27 SF-36 bodily pain: +3.4 and +9.3 SF-36 general health: +3.0 and +9.9 SF-36 vitality: +12 and +12 SF-36 social function: +9.5 and +11 SF-36 role limitations-emotional: +20 and +18 SF-36 mental health: +14 and +18 SF-36 physical component summary: +3.8 and +7.1 SF-36 mental component summary: +6.0 and +2.1 Positive well being: +14 and −3.1 Sleep somnolence: +11 and +5.4 Health distress: +9.3 and +11 Hepatitis-specific health distress: +5.4 and +2.6 Hepatitis-specific limitations: +13 and +3.8 |
| Bonkovsky, 19994 USA and Canada Quality: Poor | SVR vs. no SVR SVR=No detectable HCV RNA 24 weeks after completion of antiviral therapy | Not reported by SVR status Mean age: 43 years Female: 27% Race: Non-white: 23% Cirrhosis: 16% Genotype 1: 68% Viral load: Not reported IVDU: 41% HIV positive: excluded | Consensus interferon or interferon alfa-2b | SVR vs. no SVR, mean difference in change from baseline (values estimated from graph) SF-36 physical function: +6.0 (p<0.05) SF-36 role limitations-physical: +22 (p<0.01) SF-36 bodily pain: −0.5 (p>0.05) SF-36 general health: +7.5 (p<0.01) SF-36 vitality: +9.5 (p<0.05) SF-36 social function: +10 (p<0.05) SF-36 role limitations-emotional: +11 (p>0.05) SF-36 mental health: +4.0 (p>0.05) |
| Hassanein, 20045 Australia, North America, Europe, Taiwan, Brazil, Mexico Quality: Poor | SVR vs. no SVR SVR=No detectable HCV RNA 24 weeks after completion of antiviral therapy | Not reported by SVR status Mean age: 43 years Female: 29% Race: Non-white: 16% Cirrhosis: 13% Genotype 1: 63% Viral load: 5.9 to 6.0 × 106 copies/ml IVDU: Not reported HIV positive: excluded | Pegylated interferon alfa-2a, pegylated interferon alf-2a +ribavirin, or interferon alfa-2b + ribavirin | SVR vs. no SVR, mean difference in change from baseline SF-36 physical function: +5.5 (p<0.01) SF-36 role limitations-physical: +5.7 (p<0.05) SF-36 bodily pain: +4.1 (p<0.05) SF-36 general health: +8.6 (p<0.01) SF-36 vitality: +6.3 (p >0.05) SF-36 social function: +5.8 (p<0.01) SF-36 role limitations-emotional: +9.3 (p<0.01) SF-36 mental health: +5.0 (p<0.01) SF-36 physical component summary: +2.2 (p<0.01) SF-36 mental component summary: +2.6 (p<0.01) Total fatigue: +3.3 (p<0.01) Fatigue severity: +7.4 (p<0.01) |
| McHutchison, 20016 USA Quality: Poor | SVR vs. relapse vs. non-responder SVR=No detectable HCV RNA 24 weeks after completion of antiviral therapy Relapse: Not defined | Mean age: 43 vs. 44 years Female: 42% vs. 32% Race: Non-white: 8% vs. 12% Cirrhosis: Not reported Genotype 1: 43% vs. 81% Viral load >2 million copies/ml: 58% vs. 74% IVDU: Not reported HIV positive: excluded | Interferon alfa-2a for 24 or 48 weeks, with or without ribavirin | SVR and relapse, mean difference in change from baseline vs. non-responder (p not reported, values estimated from graph) SF-36 physical function: +2.4 and +0.8 SF-36 role limitations-physical: +5.2 and +3.2 SF-36 bodily pain: +1.6 and +1.7 SF-36 general health: +5.2 and +1.5 SF-36 vitality: +4.7 and +2.0 SF-36 social function: +3.1 and +0.4 SF-36 role limitations-emotional: +3.0 and +1.2 SF-36 mental health: +2.0 and 0.0 Sleep somnolence: +3.4 and +2.3 Health distress: +5.4 and +1.2 Hepatitis-related health distress: +5.7 and +1.1 Hepatitis-related limitations: +4.6 and +2.1 |
| Neary, 19997 USA, Europe, Australia Quality: Poor | SVR vs. no SVR and overall response versus no overall response SVR=No detectable HCV RNA 24 weeks after completion of antiviral therapy Overall response=SVR plus >=2-point improvement in Knodell HAI score | Not reported by SVR or overall response status Mean age: 43 years Female: 35% Race: Non-white: 6.4% Not reported by SVR or overall response status Bridging fibrosis or cirrhosis: 17% Genotype 1: 56% Viral load >2 million copies/ml: 75% IVDU: 40% HIV positive: excluded | Interferon alfa-2b with or without ribavirin | SVR and relapse. mean difference in change from baseline vs. non-responder (estimated from graph) (p values not reported) SF-36 physical function: +8.0 and +3.8 SF-36 role limitations-physical: +7.6 and +4.9 SF-36 bodily pain: +2.4 and +2.7 SF-36 general health: +9.4 and +5.6 SF-36 vitality: +7.8 and +5.6 SF-36 social function: +9.4 and +4.1 SF-36 role limitations-emotional: +6.0 and +12 SF-36 mental health: +2.8 and +1.8 Sleep somnolence: +2.1 and +3.8 Health distress: +8.9 and +1.6 Hepatitis-related health distress: +11 and -0.8 Hepatitis-related limitations: +6.7 and +2.6 Mental health-18: +3.4 and +2.3 Overall response vs. no response (estimated from graph) SF-36 physical function: +8.3 (p<0.05) SF-36 role limitations-physical: +10 (p>0.05) SF-36 bodily pain: +3.7 (p>0-.05) SF-36 general health: +6.9 (p<0.05) SF-36 vitality: +5.8 (p<0.05) SF-36 social function: +9.2 (p<0.05) SF-36 role limitations-emotional: +3.6 (p>0.05) SF-36 mental health: +1.3 (p>0.05) Sleep somnolence: +1.5 (p>0.05) Health distress: +6.4 (p<0.05) Hepatitis-related health distress: +12 (p<0.05) Hepatitis-related limitations: +7.8 (p<0.05) Mental health-18: +1.5 (p>0.05) |
| Rasenack, 20038 Germany, Canada, New Zealand, Spain Quality: Poor | SVR vs. no SVR SVR=No detectable HCV RNA 24 weeks after completion of antiviral therapy | Not reported by SVR status Mean age: 41 years Female: 33% Race: Non-white: 15% Bridging fibrosis/cirrhosis: 13% Injection drug use: 37% Viral load: 7.4 to 8.2 × 106 copies/ml HIV positive: Not reported Genotype: Not reported | Pegylated interferon alfa-2a or interferon alfa-2a | SVR vs. no SVR, mean difference in change from baseline SF-36 physical function: +5.0 (p=0.001) SF-36 role limitations-physical: +14 (p<0.001) SF-36 bodily pain: +5.2 (p=0.014) SF-36 general health: 12 (p<0.001) SF-36 vitality: +9.4 (p<0.001) SF-36 social function: +5.8 (p=0.005) SF-36 role limitations-emotional: +8.4 (p=0.02) SF-36 mental health: +5.3 (p=0.001) SF-36 physical component summary: +3.2 (p<0.001) SF-36 mental component summary: +2.9 (p=0.005) Fatigue Severity Scale, total score: −0.5 (p=0.001) Fatigue Severity Scale, VAS: −8.4 (p<0.001) |
| Ware, 19999 Australia, North America, and Europe Quality: Poor | SVR vs. no SVR SVR=No detectable HCV RNA 24 weeks after completion of antiviral therapy Overall response vs. no overall response Overall response=SVR + Knodell histology activity index inflammation score improved by 2 U or more | Not reported by response status Mean age: 43 years Female: 35% Race: Non-white: 6.4% Bridging fibrosis/cirrhosis: 18% Injection drug use: 40% Viral load: 4.8 to 5.2 × 106 copies/ml HIV positive: Excluded Genotype 1: 56% | Interferon alfa-2b or interferon alfa-2b + ribavirin | SVR vs. no SVR and overall response vs. no overall response, mean difference in change from baseline (p values not reported) SF-36 physical function: +2.6 and +3.5 SF-36 role limitations-physical: +1.5 and +3.1 SF-36 bodily pain: +0.45 and +1.6 SF-36 general health: +3.3 and +3.5 SF-36 vitality: +2.2 and +2.8 SF-36 social function: +3.4 and +4.3 SF-36 role limitations-emotional: −0.02 and +1.1 SF-36 mental health: +1.3 and +0.62 Sleep: +0.02 and +1.2 Health distress: +7.6 and +6.2 Chronic hepatitis C health distress: +11.5 and +11.3 Chronic hepatitis C limitations: +5.3 and +7.5 |
Abbreviations: ALT, alanine aminotransferase; HCV, hepatitis C virus; SVR, sustained virologic response.
Appendix F References
- 1.
- Arora S, O'Brien C, Zeuzem S, et al. Treatment of chronic hepatitis C patients with persistently normal alanine aminotransferase levels with the combination of peginterferon alpha-2a (40 kDa) plus ribavirin: impact on health-related quality of life. Journal of Gastroenterology & Hepatology. 2006 Feb;21(2):406–12. [PubMed: 16509866]
- 2.
- Bernstein D, Kleinman L, Barker CM, et al. Relationship of health-related quality of life to treatment adherence and sustained response in chronic hepatitis C patients. Hepatology. 2002 Mar;35(3):704–8. [PubMed: 11870387]
- 3.
- Bini EJ, Mehandru S. Sustained virological response rates and health-related quality of life after interferon and ribavirin therapy in patients with chronic hepatitis C virus infection and persistently normal alanine aminotransferase levels. Aliment Pharmacol Ther. 2006;23(6):777–85. [PubMed: 16556180]
- 4.
- Bonkovsky HL, Woolley JM. Reduction of health-related quality of life in chronic hepatitis C and improvement with interferon therapy. The Consensus Interferon Study Group. Hepatology. 1999;29(1):264–70. [PubMed: 9862876]
- 5.
- Hassanein T, Cooksley G, Sulkowski M, et al. The impact of peginterferon alfa-2a plus ribavirin combination therapy on health-related quality of life in chronic hepatitis C. Journal of Hepatology. 2004;40(4):675–81. [PubMed: 15030985]
- 6.
- McHutchison J, Manns M, Harvey J, et al. Adherence to therapy enhanges sustained response in chronic hepatitis C patients receiving PEG-Interferon alfa-2b plus Ribavirin[abstract] Journal of Hepatology. 2001;34(1):2–3.
- 7.
- Neary MP, Cort S, Bayliss MS, et al. Sustained virologic response is associated with improved health-related quality of life in relapsed chronic hepatitis C patients. Semin Liver Dis. 1999;19(Suppl 1):77–85. [PubMed: 10349695]
- 8.
- Rasenack J, Zeuzem S, Feinman SV, et al. Peginterferon alpha-2a (40kD) [Pegasys] improves HR-QOL outcomes compared with unmodified interferon alpha-2a [Roferon-A]: in patients with chronic hepatitis C. Pharmacoeconomics. 2003;21(5):341–9. [Erratum appears in Pharmacoeconomics. 2003;21(17):1290] [PubMed: 12627987]
- 9.
- Ware JE, Bayliss MS, Mannocchia M, et al. Health-related quality of life in chronic hepatitis C: impact of disease and treatment response. The Interventional Therapy Group. Hepatology. 1999;30(2):550–5. [PubMed: 10421667]
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