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Review
. 2011 Mar;26(3):326-39.
doi: 10.1007/s11606-010-1569-5. Epub 2011 Jan 4.

Systematic review of the literature on comparative effectiveness of antiviral treatments for chronic hepatitis B infection

Tatyana A Shamliyan  1 , James R Johnson, Roderick MacDonald, Aasma Shaukat, Jian-Min Yuan, Robert L Kane, Timothy J Wilt
Affiliations
Review

Systematic review of the literature on comparative effectiveness of antiviral treatments for chronic hepatitis B infection

Tatyana A Shamliyan et al. J Gen Intern Med. 2011 Mar.

Abstract

Objectives: To evaluate the comparative effectiveness of antiviral drugs in adults with chronic hepatitis B monoinfection for evidence-based decision-making.

Methods: A systematic review of randomized controlled clinical trials (RCTs) published in English. Results after interferon and nucleos(t)ides analog therapies were synthesized with random-effects meta-analyses and number needed to treat (NNT).

Results: Despite sustained improvements in selected biomarkers, no one drug regimen improved all intermediate outcomes. In 16 underpowered RCTs, drug treatments did not reduce mortality, liver cancer, or cirrhosis. Sustained HBV DNA clearance was achieved in one patient when two were treated with adefovir (NNT from 1 RCT=2 95%CI 1;2) or interferon alpha-2b (NNT from 2 RCTs=2 95%CI 2;4), 13 with lamivudine (NNT from 1 RCT=13 95%CI 7;1000), and 11 with peginterferon alpha-2a vs. lamivudine (NNT from 1 RCT=11 95%CI 7;25). Sustained HBeAg seroconversion was achieved in one patient when eight were treated with interferon alpha-2b (NNT from 2 RCTs=8 95%CI 5;33) or 10--with peginterferon alpha-2b vs. interferon alpha-2b (NNT from 1 RCT=10 95%CI 5;1000). Greater benefits and safety after entecavir vs. lamivudine or pegylated interferon alpha-2b vs. interferon alpha-2b require future investigation of clinical outcomes. Adverse events were common and more frequent after interferon. Treatment utilization for adverse effects is unknown.

Conclusions: Individual clinical decisions should rely on comparative effectiveness and absolute rates of intermediate outcomes and adverse events. Future research should clarify the relationship of intermediate and clinical outcomes and cost-effectiveness of drugs for evidence-based policy and clinical decisions.

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Figures

Figure 1
Figure 1
Results from randomized controlled clinical trials that compared active treatments to placebo at the end of the treatment.
Figure 2
Figure 2
Results from randomized controlled clinical trials that compared active mono-treatments at the end of the treatment.
Figure 3
Figure 3
Results from randomized controlled clinical trials that compared combined therapy vs. monotherapy at the end of the treatment.
Figure 4
Figure 4
Sustained results from randomized controlled clinical trials that compared active treatments to placebo at follow up off the treatment.
Figure 5
Figure 5
Sustained results from randomized controlled clinical trials that compared active treatments at follow up off the treatment.
Figure 6
Figure 6
Rates (%) of clinical and intermediate outcomes in HBe antigen positive patients (pooled from randomized controlled clinical trials with random effects models).
See this image and copyright information in PMC

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