Treatment with pegylated interferon alpha 2b and ribavirin in patients unresponsive to previous treatments with standard interferon as monotherapy or combined with ribavirin

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Abstract

Background: little information is available on the effect of pegylated interferon (PEG) and ribavirin (RBV) in patients with chronic hepatitis due to virus C (CHC) who were non-responders to previous treatment. Objectives: to evaluate response to treatment in patients who were non-responders to previous treatment. Methods: one hundred and twenty-four patients who were non-responders to previous treatment were included. All patients were treated with PEG alpha 2b interferon (dose: 1.5 mg/kg body weight) and RBV (weight-dependent dosage). A qualitative PCR of virus C after six months was evaluated. In those in whom this was positive, treatment was discontinued; in those who were negative treatment was continued to the end of the year. Results: response following treatment (RFT) was 35.4% (44 patients), and sustained viral response (SVR) 29.8% (37 patients). No relation was observed between RFT, SVR and any previous treatment. RFT was dependent on low initial viremia and SVR was significantly and independently related to low serum hepatitis C RNA and a non-1 genotype. In general, treatment was well tolerated. Medication was discontinued in 5 patients, and doses reduced in 18. Conclusion: on retreatment with PEG and RBV a SVR of 29.8% was achieved in patients who had not responded to previous treatment, so its use in this group of patients is indicated.

Translated abstract

Introducción: existe poca información del resultado del tratamiento con interferón pegilado (PEG) y ribavirina (RBV) en enfermos con hepatitis crónica por virus C (HCC) no respondedores a tratamientos previos. Objetivos: valorar la respuesta al tratamiento en enfermos no respondedores a tratamientos anteriores. Métodos: se incluyeron 124 enfermos no respondedores a tratamientos previos. Todos los pacientes fueron tratados con PEG interferón alfa 2b (dosis: 1,5 mg/kg peso) y RBV (dosis ajustada al peso). Se valoró la PCR cualitativa del virus C al 6º mes. A los que la presentaban positiva se suspendió el tratamiento, mientras en los que era negativa se continuó el mismo hasta finalizar un año. Resultados: la respuesta al final de tratamiento (RFT) fue del 35,4% (44 enfermos) y la respuesta viral sostenida (RVS) del 29,8% (37 enfermos). No se observó que existiera relación alguna entre la RFT y la RVS con el tratamiento previo. La RFT fue dependiente de la existencia de una viremia baja al inicio del tratamiento y la RVS se relacionó de forma significativa e independiente con una viremia baja y un genotipo distinto al 1. El tratamiento fue bien tolerado en general. Se suspendió la medicación en 5 enfermos y se redujo la dosis en 18. Conclusión: el retratamiento con PEG y RBV consigue una RVS del 29,8% de los enfermos no respondedores a tratamientos previos, por lo que estaría indicado su uso en este grupo de enfermos.

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Most cited references 19

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Adherence to combination therapy enhances sustained response in genotype-1-infected patients with chronic hepatitis C.

Carmen Ka-Man Mak, Christian Trepo, Michael Peter Manns … (2002)

Patient adherence to prescribed antiviral therapy in human immunodeficiency virus infection enhances response. We evaluated the impact of adherence to combination therapy with interferon or peginterferon plus ribavirin in chronic hepatitis C patients. We assessed the effect of dose reduction on sustained virologic response (SVR) from prior trials with interferon alpha-2b plus ribavirin (n = 1010) or peginterferon alpha-2b 1.5 microg/kg/week plus ribavirin (n = 511). The actual treatment administered was verified from drug dispensing/return records and patient diaries. Two groups were defined: (1) patients who received >or=80% of both their total interferon and ribavirin doses for >or=80% of the expected duration of therapy and (2) patients who received reduced doses ( or=80% of the expected duration of therapy). A statistical model provided comparative estimates of the response rates in compliant patients. Most patients were at least 80% compliant with interferon alpha-2b/ribavirin or peginterferon alpha-2b/ribavirin therapy and had SVR rates of 52% and 63%, respectively, for the 2 regimens. This was most apparent for HCV-1-infected patients. The impacts of adherence on efficacy from subgroup analysis and the statistical modeling approach were similar. HCV-1-infected patients who can be maintained on >80% of their interferon or peginterferon alpha-2b and ribavirin dosage for the duration of treatment in the setting of a clinical trial exhibit enhanced sustained response rates. Our results suggest that adherence will enhance the likelihood of achieving an initial virologic response. Adherence beyond 12-24 weeks will be advantageous only for those patients who have achieved such an early virologic response.