Sonali Paul, MD, MS; Akriti Saxena, MD; Norma Terrin, PhD; Kathleen Viveiros, MD; Ethan M. Balk, MD, MPH; John B. Wong, MD
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Grant Support: By the National Center for Advancing Translational Sciences and National Institutes of Health (grants UL1 TR001064 and UL1 TR000073). Dr. Paul received grant support through the 2013 to 2014 Bristol-Myers Squibb Virology Research Training Program.
Disclosures: Dr. Paul reports grants from National Center for Advancing Translational Sciences, National Institutes of Health, and the 2013 to 2014 Bristol-Myers Squibb Virology Research Training Program during the conduct of the study. Dr. Wong reports nonfinancial support from the American Association for the Study of Liver Diseases (as a member of systematic review writing group for an HBV practice guideline) outside the submitted work. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-1121.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer.
Reproducible Research Statement:Study protocol, statistical code, and data set: Available from Dr. Paul upon request (e-mail, firstname.lastname@example.org).
Requests for Single Reprints: Sonali Paul, MD, MS, Massachusetts General Hospital Gastroenterology Associates, 55 Fruit Street, Blake 4, Boston, MA 02114; e-mail, email@example.com.
Current Author Addresses: Dr. Paul: Massachusetts General Hospital Gastroenterology Associates, 55 Fruit Street, Blake 4, Boston, MA 02114.
Dr. Saxena: Boston Medical Center, Gastroenterology, Moakley Building, 2nd Floor, 830 Harrison Avenue, Boston, MA 02118.
Dr. Terrin: Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, 35 Kneeland Street, 9th Floor, Boston, MA 02111.
Dr. Viveiros: Division of Gastroenterology and Hepatology, Tufts Medical Center, 800 Washington Street, Box 233, Boston, MA 02111.
Dr. Balk: Center for Evidence-Based Medicine, Brown University School of Public Health, Box G-S121-8, Providence, RI 02912.
Dr. Wong: Division of Clinical Decision Making, Tufts Medical Center, 35 Kneeland Street, 7th Floor, Boston, MA 02111.
Author Contributions: Conception and design: S. Paul, N. Terrin, K. Viveiros, J.B. Wong.
Analysis and interpretation of the data: S. Paul, A. Saxena, N. Terrin, J.B. Wong.
Drafting of the article: S. Paul, N. Terrin, J.B. Wong.
Critical revision of the article for important intellectual content: S. Paul, N. Terrin, K. Viveiros, E.M. Balk, J.B. Wong.
Final approval of the article: S. Paul, N. Terrin, K. Viveiros, E.M. Balk, J.B. Wong.
Statistical expertise: N. Terrin, E.M. Balk, J.B. Wong.
Obtaining of funding: S. Paul.
Collection and assembly of data: S. Paul, A. Saxena.
Solid tumor chemotherapy regimens pose a risk for hepatitis B virus (HBV) reactivation, but screening and antiviral prophylaxis remains controversial because of insufficient evidence.
To determine the risk for HBV reactivation with and without antiviral prophylaxis and the effectiveness of prophylaxis in adults with solid tumors and chronic or resolved HBV infection.
MEDLINE through 1 July 2015 and Web of Science, Cochrane Central Register of Controlled Trials, TOXNET, and Scopus through 1 March 2015.
26 English-language observational studies and randomized, controlled trials in patients with chronic or resolved HBV receiving chemotherapy for solid tumors.
Study characteristics, quality, and risk of bias were assessed by 1 researcher and verified by another independent researcher.
Random-effects model meta-analyses were used to estimate the risk and odds ratio (OR) of reactivation with versus without antiviral prophylaxis. Reactivation in chronic HBV without prophylaxis ranged from 4% to 68% (median, 25%) with substantial heterogeneity. Prophylaxis reduced the risk for HBV reactivation (OR, 0.12 [95% CI, 0.06 to 0.22]), HBV-related hepatitis (OR, 0.18 [CI, 0.10 to 0.32]), and chemotherapy interruption (OR, 0.10 [CI, 0.04 to 0.27]). In 3 studies of patients with resolved HBV infection, none received HBV prophylaxis and reactivation risk ranged from 0.3% to 9.0%.
Significant heterogeneity in underlying study populations and treatment regimens, incomplete baseline data, possibility of publication bias, and limited study quality. Most studies were observational and from Asia.
In patients with chronic HBV receiving solid tumor chemotherapy, the risk for HBV reactivation is similar to the risk with other types of immunosuppressive therapy. Results support HBV screening and antiviral prophylaxis before initiation of chemotherapy for solid tumors.
National Center for Advancing Translational Sciences and National Institutes of Health.
Paul S, Saxena A, Terrin N, et al. Hepatitis B Virus Reactivation and Prophylaxis During Solid Tumor Chemotherapy: A Systematic Review and Meta-analysis. Ann Intern Med. 2016;164:30–40. [Epub ahead of print 24 November 2015]. doi: https://doi.org/10.7326/M15-1121
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Published: Ann Intern Med. 2016;164(1):30-40.
Published at www.annals.org on 24 November 2015
Gastroenterology/Hepatology, Infectious Disease, Viral Hepatitis.
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