Skip directly to search Skip directly to A to Z list Skip directly to site content
CDC Home

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

Study event rates

Relative effect

Anticipated absolute effects*

No. Participants

No. Studies

Overall quality of evidence

Failed or no treatment

SVR

Risk with failed or no treatment

Absolute effect with SVR

No./N

%

No./N

%

HR

CI

No.

CI

All-cause mortality

16,864
(ref 1)

1

Low

1,126/9,430

(11.9)

409/7,434

(5.5)

0.7

(0.590.83)

119

34 fewer

(1947)

HCC

25,906
(ref 2–13)

12

Moderate

145/9,185

(1.6)

1,012/16,721

(6.1)

0.24

(0.180.31)

46

23 fewer

(2124)

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 = 0.180.31.

§ 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: 35). 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]:790800.)


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

Study event rates

Relative effect

Anticipated absolute effects*

No. Participants

No. Studies

Overall quality of evidence

Failed or no treatment

SVR

Risk with failed or no treatment

Absolute effect with SVR

No./N

%

No./N

%

RR

CI

No.

CI

SAEs

2,704
(ref 15–19)

5

Moderate

105/985

(10.7)

235/1,719

(13.7)

1.34

(0.951.87)

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 = 1.162.22) (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

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: 89456 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

  1. Backus LI, Boothroyd DB, Phillips BR, Belperio P, Halloran J, Mole LA. A sustained virologic response reduces risk of all-cause mortality in patients with hepatitis C. Clin Gastroenterol Hepatol 2011;9:509–16.
  2. Asahina Y, Tsuchiya K, Tamaki N, et al. Effect of aging on risk for hepatocellular carcinoma in chronic hepatitis C virus infection. Hepatology 2010;52:518–27.
  3. Hung CH, Lee CM, Wang JH, et al. Impact of diabetes mellitus on incidence of hepatocellular carcinoma in chronic hepatitis C patients treated with interferon-based antiviral therapy. Int J Cancer 2011;128:2344–52.
  4. Kawamura Y, Arase Y, Ikeda K, et al. Diabetes enhances hepatocarcinogenesis in noncirrhotic, interferon-treated hepatitis C patients. Am J Med 2010;123:951–6.
  5. Kramer JR, Davila JA, Duan Z, Richardson PA, Kanwal F, El-Serag H. Antiviral treatment for hepatitis C virus is associated with a reduced risk of hepatocellular carcinoma in a national cohort of U.S. veterans. Presented at Digestive Disease Week; Chicago, Illinois; May 7, 2011.
  6. Kurokawa M, Hiramatsu N, Oze T, et al. Effect of interferon alpha-2b plus ribavirin therapy on incidence of hepatocellular carcinoma in patients with chronic hepatitis. Hepatology Research 2009;39:432–8.
  7. Okanoue T, Itoh Y, Kirishima T, et al. Transient biochemical response in interferon therapy decreases the development of hepatocellular carcinoma for five years and improves the long-term survival of chronic hepatitis C patients. Hepatology Research 2002;23:62–77.
  8. Osaki Y, Ueda Y, Marusawa H, et al. Decrease in alpha-fetoprotein levels predicts reduced incidence of hepatocellular carcinoma in patients with hepatitis C virus infection receiving interferon therapy: a single center study. J Gastroenterol 2012;47:444–51.
  9. Pradat P, Tillmann HL, Sauleda S, et al. Long-term follow-up of the hepatitis C HENCORE cohort: response to therapy and occurrence of liver-related complications. J Viral Hepat 2007;14:556–63.
  10. Sinn DH, Paik SW, Kang P, et al. Disease progression and the risk factor analysis for chronic hepatitis C. Liver International 2008;28:1363–9.
  11. 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.
  12. Tateyama M, Yatsuhashi H, Taura N, et al. Alpha-fetoprotein above normal levels as a risk factor for the development of hepatocellular carcinoma in patients infected with hepatitis C virus. J Gastroenterol 2011;46:92–100.
  13. Yoshida H, Shiratori Y, Moriyama M, et al. Interferon therapy reduces the risk for hepatocellular carcinoma: national surveillance program of cirrhotic and noncirrhotic patients with chronic hepatitis C in Japan. IHIT Study Group. Inhibition of Hepatocarcinogenesis by Interferon Therapy. Ann Intern Med 1999;131:174–81.
  14. 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.
  15. 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.
  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.
  17. Poordad F, McCone J, Bacon B, et al. Boceprevir for untreated chronic HCV genotype 1 infection. New Engl J Med 2011;364:1195–206.
  18. 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.
  19. 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.
  20. Kaner EF, Beyer F, Dickinson HO, et al. Effectiveness of brief alcohol interventions in primary care populations. Cochrane Database Syst Rev 2007:CD004148.

Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services.

References to non-CDC sites on the Internet are provided as a service to MMWR readers and do not constitute or imply endorsement of these organizations or their programs by CDC or the U.S. Department of Health and Human Services. CDC is not responsible for the content of pages found at these sites. URL addresses listed in MMWR were current as of the date of publication.

All MMWR HTML versions of articles are electronic conversions from typeset documents. This conversion might result in character translation or format errors in the HTML version. Users are referred to the electronic PDF version (http://www.cdc.gov/mmwr) and/or the original MMWR paper copy for printable versions of official text, figures, and tables. An original paper copy of this issue can be obtained from the Superintendent of Documents, U.S. Government Printing Office (GPO), Washington, DC 20402-9371; telephone: (202) 512-1800. Contact GPO for current prices.

**Questions or messages regarding errors in formatting should be addressed to mmwrq@cdc.gov.

 
USA.gov: The U.S. Government's Official Web PortalDepartment of Health and Human Services
Centers for Disease Control and Prevention   1600 Clifton Road Atlanta, GA 30329-4027, USA
800-CDC-INFO (800-232-4636) TTY: (888) 232-6348 - Contact CDC–INFO
A-Z Index
  1. A
  2. B
  3. C
  4. D
  5. E
  6. F
  7. G
  8. H
  9. I
  10. J
  11. K
  12. L
  13. M
  14. N
  15. O
  16. P
  17. Q
  18. R
  19. S
  20. T
  21. U
  22. V
  23. W
  24. X
  25. Y
  26. Z
  27. #