Sustained Virologic Response and Quality of Life

Roger Chou; Daniel Hartung; Basmah Rahman; Ngoc Wasson; Erika Cottrell; Rongwei Fu

Appendix FSustained Virologic Response and Quality of Life

Publication Details

Table

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]

Publication Details

Copyright

Publisher

Agency for Healthcare Research and Quality (US), Rockville (MD)

NLM Citation

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.) Appendix F, Sustained Virologic Response and Quality of Life.

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.