Interferon alpha-2b and ribavirin in combination for patients with chronic hepatitis C who failed to respond to, or relapsed after, interferon alpha therapy: a randomized trial

Bárbaro, Giuseppe; Lorenzo, G. Di; Belloni, G; Ferrari, Luisella; Paiano, Aldo; Poggio, P. Del; Bacca, D.; Fruttaldo, L; Mongiò, Franco; Francavilla, Ruggiero; Scotto, Gaetano; Grisorio, Benvenuto; Calleri, Guido; Annese, Mauro; Barelli, Andrea; Rocchetto, Piero; Rizzo, Giovanni; Gualandi, Guido; Poltronieri, Italo; Barbarini, Giorgio

doi:10.1016/s0002-9343(99)00160-6

Cited by 71 publications

(86 citation statements)

References 23 publications

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“…[11][12][13][14][15][16][17] Two studies were conducted by the same lead investigator, who was contacted to ensure that the patient populations did not overlap. 18,19 Thus, 9 randomized controlled trials were used for the primary meta-analysis. [18][19][20][21][22][23][24][25][26] Table 1 shows the characteristics of these trials, which included a total of 789 patients.…”

Section: Randomized Controlledmentioning

confidence: 99%

“…18,19 Thus, 9 randomized controlled trials were used for the primary meta-analysis. [18][19][20][21][22][23][24][25][26] Table 1 shows the characteristics of these trials, which included a total of 789 patients. Prior nonresponse to IFN monotherapy was not explicitly defined in 2 studies.…”

Section: Randomized Controlledmentioning

confidence: 99%

“…A biochemical ETR (BETR) could be evaluated in 7 trials [18][19][20]22,[24][25][26] with a total of 752 patients, of which 6 showed significant improvement among patients treated with combination therapy compared with IFN monotherapy. [18][19][20]22,24,26 The overall weighted response was 39.4% with a common odds ratio (OR) of 5.5 (95% CI 3.7-8.0) in favor of combination therapy.…”

Section: Randomized Controlledmentioning

confidence: 99%

“…[18][19][20]22,24,26 The overall weighted response was 39.4% with a common odds ratio (OR) of 5.5 (95% CI 3.7-8.0) in favor of combination therapy.…”

Section: Randomized Controlledmentioning

confidence: 99%

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Interferon and Ribavirin for Patients With Chronic Hepatitis C Who Did Not Respond to Previous Interferon Therapy: A Meta–Analysis of Controlled and Uncontrolled Trials

Cheng

2001

Hepatology

101

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The efficacy of interferon (IFN) combined with ribavirin for the treatment of patients with hepatitis C who failed to respond to initial IFN therapy is not well established. The primary goal of this study was to perform a systematic review of the literature evaluating the efficacy of combination therapy in nonresponders. Studies were retrieved from MEDLINE, abstracts of scientific meetings, and review of the bibliographies of retrieved studies. Controlled trials were included in the primary analysis whereas uncontrolled trials and trials reported as abstracts were included for sensitivity analysis. The primary endpoints were biochemical and virologic response. A combined estimate of the odds ratio (OR) for each endpoint was obtained by using the random effects model. The number needed to treat (NNT) was calculated by taking the inverse of the pooled risk difference. Nine controlled trials (789 patients) were identified. Six months after treatment, the overall sustained biochemical and virologic responses to 24 weeks of combination therapy were 15.2% and 13.2% with a common OR of 3.8 (95% confidence interval [CI] 2.2-6.7) and 4.9 (95% CI 2.1-11.2) compared with patients treated with IFN monotherapy. The pooled risk difference for the sustained virologic response (SVR) to combination therapy was 7% (95% CI 2-13). The NNT was 14 (95% CI Chronic hepatitis C virus (HCV) infection is a major cause of liver disease worldwide. 1 Interferon (IFN) alfa was the first approved therapy but resulted in a sustained virologic response (SVR) in only a minority of patients. A major advance in treatment was the observation that the addition of ribavirin to IFN (combination therapy) was associated with a significantly higher SVR rate compared with IFN alone. Four large, international multicenter studies have shown that combination therapy was substantially more effective than IFN monotherapy in patients who had previously relapsed virologically or biochemically after IFN monotherapy (relapsers), and in patients who had never been treated with IFN (naive patients). [2][3][4][5] Much less is known about the efficacy of combination therapy in patients who failed to respond to IFN monotherapy (nonresponders), a group representing more than one half of all patients treated with IFN. 6 A number of uncontrolled studies and an increasing number of controlled trials have suggested that the efficacy of re-treatment with combination therapy may be higher than for re-treatment with IFN alone. However, the rate of SVR after combination therapy in nonresponders has varied among available reports. Furthermore, the extent to which a response can be predicted by patient-or treatment-related characteristics remains uncertain. Thus, the primary goal of this study was to assess the available evidence showing the efficacy of combination therapy in nonresponders by performing a systematic review of the literature with a meta-analysis of controlled trials.8

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Section: Randomized Controlledmentioning

confidence: 99%

Section: Randomized Controlledmentioning

confidence: 99%

Section: Randomized Controlledmentioning

confidence: 99%

“…[18][19][20]22,24,26 The overall weighted response was 39.4% with a common odds ratio (OR) of 5.5 (95% CI 3.7-8.0) in favor of combination therapy.…”

Section: Randomized Controlledmentioning

confidence: 99%

See 2 more Smart Citations

Interferon and Ribavirin for Patients With Chronic Hepatitis C Who Did Not Respond to Previous Interferon Therapy: A Meta–Analysis of Controlled and Uncontrolled Trials

Cheng

2001

Hepatology

101

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“…However, the combination of interferonalpha and ribavirin is superior to interferon alpha alone in inducing sustained remission from HCV in patients who have not previously been treated with interferon alpha (581)(582)(583)(584)(585)(586). Similarly, the combination appears to be superior to alphainterferon alone in patients who have previously been treated with interferon alpha, but have relapsed (585,(589)(590)(591). The incidence of adverse effects of combination therapy is (71) Rx, treatment.…”

Section: The Evaluation Of Renal Transplant Candidates: Clinical Pracmentioning

confidence: 99%

The Evaluation of the Renal Transplant Candidates: Clinical Practice Guidelines

2001

American Journal of Transplantation

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Interferon and Ribavirin vs Interferon Alone in the Re-treatment of Chronic Hepatitis C Previously Nonresponsive to Interferon

Cummings¹,

Lee²,

West³

et al. 2001

JAMA

155

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Interferon alpha-2b and ribavirin in combination for patients with chronic hepatitis C who failed to respond to, or relapsed after, interferon alpha therapy: a randomized trial

Cited by 71 publications

References 23 publications

Interferon and Ribavirin for Patients With Chronic Hepatitis C Who Did Not Respond to Previous Interferon Therapy: A Meta–Analysis of Controlled and Uncontrolled Trials

Interferon and Ribavirin for Patients With Chronic Hepatitis C Who Did Not Respond to Previous Interferon Therapy: A Meta–Analysis of Controlled and Uncontrolled Trials

The Evaluation of the Renal Transplant Candidates: Clinical Practice Guidelines

Interferon and Ribavirin vs Interferon Alone in the Re-treatment of Chronic Hepatitis C Previously Nonresponsive to Interferon

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