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Appendix B: Evidence Tables

Table 1. GRADE evidence profile for HCV testing followed by antiviral treatment versus no antiviral treatment
Outcome	Quality assessment			Summary of findings
	Quality assessment			Study event rates				Relative effect		Anticipated absolute effects*
	No. Participants	No. Studies	Overall quality of evidence	Failed or no treatment		SVR		Relative effect		Risk with failed or no treatment	Absolute effect with SVR
	No. Participants	No. Studies	Overall quality of evidence	No./N	%	No./N	%	HR	CI	Risk with failed or no treatment	No.	CI
All-cause mortality	16,864 (ref 1)	1	Low	1,126/9,430	(11.9)	409/7,434	(5.5)	0.7	(0.59–0.83)	119	34 fewer	(19–47)
HCC	25,906 (ref 2–13)	12	Moderate†	145/9,185	(1.6)	1,012/16,721	(6.1)	0.24	(0.18–0.31)	46	23 fewer	(21–24)
QoL	5,978 (ref 14)	7	Low	—§	—	—§	—	—	—	—	6.6 higher¶	(—)**
Abbreviations: GRADE = Grading of Recommendations, Assessment, Development, and Evaluation; HCV = hepatitis C virus; SVR = sustained virologic response; HR = hazard ratio; CI = 95% confidence interval; HCC = hepatocellular carcinoma; QoL = quality of life. * Per 1,000 persons tested for HCV infection. † Rated up due to large relative risk effect: 0.24; 95% CI = 0.18–0.31. § Total number of participants = 5,978; distribution between participants and controls not available. ¶ The mean QoL associated with sustained viral response-vitality sub-score in the intervention groups. ** 95% CI not provided. Effect was reported as significant. Minimally clinically important difference estimated to be 4.2 (range: 3–5). Effect size results: 0.2; effect sizes are classified as small (≤0.2); moderate (0.5); and large (≥0.8 ) (Spiegel BMR, Younossi Z, Hays R, Revicki D, Robbins S, Kanwal F. Impact of hepatitis C on health related quality of life: a systematic review and quantitative assessment. Hepatology. 2005;41[4]:790–800.)

Table 2. GRADE evidence profile for HCV testing followed by boceprevir or telaprevir (with PR) compared with PR alone
Outcome	Quality assessment			Summary of findings
	Quality assessment			Study event rates				Relative effect		Anticipated absolute effects*
	No. Participants	No. Studies	Overall quality of evidence	Failed or no treatment		SVR		Relative effect		Risk with failed or no treatment	Absolute effect with SVR
	No. Participants	No. Studies	Overall quality of evidence	No./N	%	No./N	%	RR	CI	Risk with failed or no treatment	No.	CI
SAEs	2,704 (ref 15–19)	5	Moderate†	105/985	(10.7)	235/1,719	(13.7)	1.34	(0.95–1.87)	107	36 more	(5–93)
Failure to achieve SVR§	2,527 (ref 15–19)	5	Moderate¶	582/985	(59.1)	493/1,542	(32.0)	0.53	(0.47–0.60)	591	278 fewer	(236–313)
Abbreviations: GRADE = Grading of Recommendations, Assessment, Development, and Evaluation; HCV = hepatitis C virus; PR = pegylated interferon plus ribavirin; SAEs = serious adverse events; RR = risk ratio; CI = confidence interval; SVR = sustained virologic response. * Per 1,000 persons receiving HCV treatment. † Rated down for imprecision. 95% CI includes harms as well as benefits. Sensitivity analysis: excluding one trial (SPRINT 2) that showed a lower discontinuation rate in the triple therapy group in one of the treatment arms compared with standard of care, the results would be as follows: RR=1.60 (95% CI = 1.16–2.22) (no imprecision). § Failure of viral negativity at 24 weeks post treatment. ¶ Rated down for indirectness. SVR considered an intermediary outcome for long-term benefit.

Table 3. GRADE evidence profile for HCV testing followed by a brief alcohol intervention versus no intervention
Outcome	Quality assessment			Summary of findings
				Study event rates		Anticipated absolute effects
				HCV testing followed by no intervention No.	HCV testing followed by intervention No.	Risk with failed or no treatment Mean	Absolute effect with SVR
	No. Participants	No. Studies	Overall quality of evidence				Absolute effect with SVR
	No. Participants	No. Studies	Overall quality of evidence				Mean	CI
Alcohol use	5,860 (ref 20)	22	Moderate	2,922	2,938	313 g alcohol/week*	38.42 g lower	(54.16–22.67)
Abbreviations: GRADE = Grading of Recommendations, Assessment, Development, and Evaluation; HCV = hepatitis C virus; CI = 95% confidence interval. * A total of 21 trials reported baseline alcohol consumption: range: 89–456 g/week; overall mean = 313 g/week (26 standard U.S. drinks [approximately 12 g each] per week; average: 3.7 drinks per day).

References

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Takahashi H, Mizuta T, Eguchi Y, et al. Post-challenge hyperglycemia is a significant risk factor for the development of hepatocellular carcinoma in patients with chronic hepatitis C. J Gastroenterol 2011;46:790–8.
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Spiegel BMR, Younossi Z, Hays R, Revicki D, Robbins S, Kanwal F. Impact of hepatitis C on health related quality of life: a systematic review and quantitative assessment. Hepatology 2005;41:790–800.
Jacobson I, McHutchison J, Dusheiko G, et al. Telaprevir for previously untreated chronic hepatitis C virus infection. New Engl J Med 2011;364:2405–16.
McHutchison JG, Everson GT, Gordon SC, et al. Telaprevir with peginterferon and ribavirin for chronic HCV genotype 1 infection. N Engl J Med 2009;360:1827–38.
Poordad F, McCone J, Bacon B, et al. Boceprevir for untreated chronic HCV genotype 1 infection. New Engl J Med 2011;364:1195–206.
Hezode C, Forestier N, Dusheiko G, et al. Telaprevir and peginterferon with or without ribavirin for chronic HCV infection. N Engl J Med 2009;360:1839–50.
Kwo PY, Lawitz EJ, McCone J, Schiff ER, Vierling JM, Pound D, et al. Efficacy of boceprevir, an NS3 protease inhibitor, in combination with peginterferon alfa-2b and ribavirin in treatment-naive patients with genotype 1 hepatitis C infection (SPRINT-1): an open-label, randomised, multicentre phase 2 trial. Lancet 2010;376:705–16.
Kaner EF, Beyer F, Dickinson HO, et al. Effectiveness of brief alcohol interventions in primary care populations. Cochrane Database Syst Rev 2007:CD004148.

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Appendix B: Evidence Tables

References

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