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Meta-Analysis
. 2014 Feb 28;2014(2):CD005642.
doi: 10.1002/14651858.CD005642.pub3.

Peginterferon alpha-2a versus peginterferon alpha-2b for chronic hepatitis C

Goran Hauser, Tahany Awad, Kristian Thorlund, Davor Štimac, Mahasen Mabrouk, Christian Gluud
Meta-Analysis

Peginterferon alpha-2a versus peginterferon alpha-2b for chronic hepatitis C

Goran Hauser et al. Cochrane Database Syst Rev. .

Abstract

Background: A combination of weekly pegylated interferon (peginterferon) alpha and daily ribavirin still represents standard treatment of chronic hepatitis C infection in the majority of patients. However, it is not established which of the two licensed peginterferon products, peginterferon alpha-2a or peginterferon alpha-2b, is the most effective and has a better safety profile.

Objectives: To systematically evaluate the benefits and harms of peginterferon alpha-2a versus peginterferon alpha-2b in head-to-head randomised clinical trials in patients with chronic hepatitis C.

Search methods: We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded, and LILACS until October 2013. We also searched conference abstracts, journals, and grey literature.

Selection criteria: We included randomised clinical trials comparing peginterferon alpha-2a versus peginterferon alpha-2b given with or without co-intervention(s) (for example, ribavirin) for chronic hepatitis C. Quasi-randomised studies and observational studies as identified by the searches were also considered for assessment of harms. Our primary outcomes were all-cause mortality, liver-related morbidity, serious adverse events, adverse events leading to treatment discontinuation, other adverse events, and quality of life. The secondary outcome was sustained virological response in the blood serum.

Data collection and analysis: Two authors independently used a standardised data collection form. We meta-analysed data with both the fixed-effect and the random-effects models. For each outcome we calculated the relative risk (RR) with 95% confidence interval (CI) based on intention-to-treat analysis. We used domains of the trials to assess the risk of systematic errors (bias) and trial sequential analyses to assess the risks of random errors (play of chance). Intervention effects on the outcomes were assessed according to GRADE.

Main results: We included 17 randomised clinical trials which compared peginterferon alpha-2a plus ribavirin versus peginterferon alpha-2b plus ribavirin in 5847 patients. All trials had a high risk of bias. Very few trials reported data on very few patients for the patient-relevant outcomes all-cause mortality, liver-related morbidity, serious adverse events, and quality of life. Accordingly, we were unable to conduct meta-analyses on all-cause mortality, liver-related morbidity, and quality of life. Twelve trials reported on adverse events leading to discontinuation of treatment without clear evidence of a difference between the two peginterferons (197/2171 (9.1%) versus 311/3169 (9.9%); RR 0.84, 95% CI 0.57 to 1.22; I2 = 44%; low quality evidence). A trial sequential analysis showed that we could exclude a relative risk reduction of 20% or more on this outcome. Peginterferon alpha-2a significantly increased the number of patients who achieved a sustained virological response in the blood serum compared with peginterferon alpha-2b (1069/2099 (51%) versus 1327/3075 (43%); RR 1.12, 95% CI 1.06 to 1.18; I2= 0%, 12 trials; moderate quality evidence). Trial sequential analyses supported this result. Subgroup analyses based on risk of bias, viral genotype, and treatment history yielded similar results. Trial sequential analyses supported the results in patients with genotypes 1 and 4, but not in patients with genotypes 2 and 3.

Authors' conclusions: There is lack of evidence on patient-important outcomes and paucity of evidence on adverse events. Moderate quality evidence suggests that peginterferon alpha-2a is associated with a higher sustained virological response in serum than with peginterferon alpha-2b. This finding may be affected by the high risk of bias of the included studies . The clinical consequences of peginterferon alpha-2a versus peginterferon alpha-2b are unknown, and we cannot translate an effect on sustained virological response into comparable clinical effects because sustained virological response is still an unvalidated surrogate outcome for patient-important outcomes. The lack of evidence on patient-important outcomes and the paucity of evidence on adverse events means that we are unable to draw any conclusions about the effects of one peginterferon over the other.

PubMed Disclaimer

Conflict of interest statement

Tahany Awad was an invited speaker for Roche and is now employed by AbbVie.

Figures

1
1
Methodological quality summary: review authors' judgements about each methodological quality item for each included trial.
2
2
Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included trials.
3
3
Trial sequential analysis (TSA): peginterferon alpha‐2a versus peginterferon alpha‐2b on the outcome serious adverse events.
 The diversity‐adjusted required information size of n = 4799 patients was calculated based upon a proportion of 13.0% of patients with serious adverse events in the peginterferon alpha‐2b group, a relative risk reduction of 20% in peginterferon alpha‐2a group, an alpha (type I error) of 5%, a beta (type II error) of 20%, and a diversity (D) of 0%. The solid blue curve presents the cumulative meta‐analysis Z‐score and the inward sloping red curves present the two‐sided Lan‐DeMets trial sequential monitoring boundaries. The cumulative Z‐score reaches the area of futility delineated by the two trial sequential monitoring boundaries.
4
4
Funnel plot of comparison: 1 Peginterferon alpha‐2a versus peginterferon alpha‐2b, outcome: 1.4. Adverse events leading to treatment discontinuation.
5
5
Trial sequential analysis (TSA): peginterferon alpha‐2a versus peginterferon alpha‐2b on the outcome adverse events leading to treatment discontinuation.
 The diversity‐adjusted required information size of n = 12,832 patients was calculated based upon a proportion of 9.0% of patients with treatment discontinuation in the peginterferon alpha‐2b group, a relative risk reduction of 20% in peginterferon alpha‐2a group, an alpha (type I error) of 5%, a beta (type II error) of 20%, and a diversity (D) of 81%. The solid blue curve presents the cumulative meta‐analysis Z‐score and the inward sloping red curves present the adjusted threshold for statistical significance according to the two‐sided Lan‐DeMets trial sequential monitoring boundaries. The cumulative Z‐score does not cross any of the monitoring boundaries and does not reach the area of futility delineated by the two trial sequential monitoring boundaries which are not even drawn by the program due to the fact that the distance between the acquired and the required information size is too large.
6
6
Funnel plot of comparison: Peginterferon alpha‐2a versus peginterferon alpha‐2b, outcome: 1.8 Sustained virological response.
7
7
Trial sequential analysis (TSA): peginterferon alpha‐2a versus peginterferon alpha‐2b on the outcome sustained virological response. 
 The diversity‐adjusted required information size of n = 4257 patients was calculated based upon a proportion of 49.6 % of patients with sustained virological response in the peginterferon alpha‐2b group, a relative risk reduction of a 10% in peginterferon alpha‐2a group, an alpha (type I error) of 5%, a beta (type II error) of 10%, and a diversity (D) of 51%. The solid blue curve presents the cumulative meta‐analysis Z‐score and the inward sloping red curves present the adjusted threshold for statistical significance according to the two‐sided Lan‐DeMets trial sequential monitoring boundaries. The cumulative Z‐score reaches the area of futility (delineated by the two trial sequential monitoring boundaries), but then it crosses both the conventional significance boundary (two tailed P = 0.05) and the trial sequential monitoring boundary.
8
8
Trial sequential analysis (TSA): peginterferon alpha‐2a versus peginterferon alpha‐2b on the two subgroup analysis sustained virological response in participants infected with hepatitis C genotype 1 and 4. 
 The diversity‐adjusted required information size of n = 6375 patients was calculated based upon a proportion of 44.9% of patients with sustained virological response in the peginterferon alpha‐2b group, a relative risk reduction of a 10% in peginterferon alpha‐2a group, an alpha (type I error) of 5%, a beta (type II error) of 10%, and a diversity (D) of 45%. The solid blue curve presents the cumulative meta‐analysis test Z‐score and the inward sloping red curves present the two‐sided Lan‐DeMets trial sequential monitoring boundaries. The cumulative Z‐score almost reaches the area of futility (delineated by the two trial sequential monitoring boundaries), but then it crosses both the conventional significance boundary (two tailed P = 0.05 ) and the trial sequential monitoring boundary.
9
9
Trial sequential analysis (TSA): peginterferon alpha‐2a versus peginterferon alpha‐2b on the two subgroup analysis sustained virological response in patients infected with hepatitis C genotype 2 and 3.The diversity‐adjusted required information size of n = 1113 patients was calculated based upon a proportion of 81.4% of patients with sustained virological response in the peginterferon alpha‐2b group, a relative risk reduction of a 10% in peginterferon alpha‐2a group, an alpha (type I error) of 5%, a beta (type II error) of 10%, and a diversity (D) of 0%. The solid blue curve presents the cumulative meta‐analysis Z‐score and the inward sloping red curves present the two‐sided Lan‐DeMets trial sequential monitoring boundaries. The cumulative Z‐score does not reach the area of futility (delineated by the two trial sequential monitoring boundaries), but it crosses the conventional significance boundary (two tailed P = 0.05). However, the cumulative Z‐score does not cross the trial sequential monitoring boundary.
10
10
Trial sequential analysis (TSA): peginterferon alpha‐2a versus peginterferon alpha‐2b on the subgroup analysis on the outcome sustained virological response in trials with low risk of randomisation bias.
 The diversity‐adjusted required information size of n = 5,624 patients was calculated based upon a proportion of 42.4 % of patients with sustained virological response in the peginterferon alpha‐2b group, a relative risk reduction of a 10% in peginterferon alpha‐2a group, an alpha (type I error) of 5%, a beta (type II error) of 10%, and a diversity (D) of 71%. The solid blue curve presents the cumulative meta‐analysis Z‐score which reaches the area of futility (delineated by the two trial sequential monitoring boundaries), but then crosses both the conventional significance boundary (two tailed P = 0.05 not shown on the figure) and the trial sequential monitoring boundary.
11
11
Trial sequential analysis (TSA): peginterferon alpha‐2a versus peginterferon alpha‐2b on the subgroup analysis on the outcome sustained virological response in trials with low risk of blinding bias.
 The diversity‐adjusted required information size of n = 2079 patients was calculated based upon a proportion of 68% of patients with sustained virological response in the peginterferon alpha‐2b group, a relative risk reduction of a 10% in peginterferon alpha‐2a group, an alpha (type I error) of 5%, a beta (type II error) of 10%, and a diversity (D) of 0%. The solid blue curve presents the cumulative meta‐analysis Z‐score and the inward sloping red curves present the two‐sided Lan‐DeMets trial sequential monitoring boundaries. The trial sequential monitoring boundaries were not broken by the cumulative Z‐curve.
1.1
1.1. Analysis
Comparison 1 Peginterferon alpha‐2a versus peginterferon alpha‐2b, Outcome 1 All‐cause mortality.
1.2
1.2. Analysis
Comparison 1 Peginterferon alpha‐2a versus peginterferon alpha‐2b, Outcome 2 Liver‐related morbidity.
1.3
1.3. Analysis
Comparison 1 Peginterferon alpha‐2a versus peginterferon alpha‐2b, Outcome 3 Serious adverse events.
1.4
1.4. Analysis
Comparison 1 Peginterferon alpha‐2a versus peginterferon alpha‐2b, Outcome 4 Adverse events leading to treatment discontinuation.
1.5
1.5. Analysis
Comparison 1 Peginterferon alpha‐2a versus peginterferon alpha‐2b, Outcome 5 All other (non serious) adverse events.
1.6
1.6. Analysis
Comparison 1 Peginterferon alpha‐2a versus peginterferon alpha‐2b, Outcome 6 Sustained virological response.
2.1
2.1. Analysis
Comparison 2 Subgroup analysis, Outcome 1 Sustained virological response according to genotype.
2.2
2.2. Analysis
Comparison 2 Subgroup analysis, Outcome 2 Sustanied virological response according to treatment history.
2.3
2.3. Analysis
Comparison 2 Subgroup analysis, Outcome 3 Sustained virological response according to risk of bias from randomisation.
2.4
2.4. Analysis
Comparison 2 Subgroup analysis, Outcome 4 Sustained virological response according to risk of bias from blinding.
2.5
2.5. Analysis
Comparison 2 Subgroup analysis, Outcome 5 Sustained virological response in patients without HIV co‐infection.
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