comparison of tenofovir plus lamivudine versus tenofovir monotherapy in patients with lamivudine-resistant chronic hepatitis b

comparación de tenofovir más lamivudina frente a monoterapia con tenofovir en pacientes con hepatitis b crónica resistente a lamivudina

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ID: 180586
2016
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Abstract
Background/Aims:Tenofovir disoproxil fumarate (TDF) exhibits similar antiviral efficacy against treatment-naïve and lamivudine (LAM)-resistant chronic hepatitis B (CHB). However, there are few clinical reports on the antiviral effects of TDF–LAM combination therapy compared to TDF monotherapy in patients with LAM-resistant CHB. Methods:We investigated the antiviral efficacy of TDF monotherapy vs. TDF–LAM combination therapy in 103 patients with LAM-resistant CHB. Results:The study subjects were treated with TDF alone (n=40) or TDF–LAM combination therapy (n=63) for ≥6 months. The patients had previously been treated with TDF-based rescue therapy for a median of 30.0 months (range, 8–36 months). A virologic response (VR) was achieved in 99 patients (96.1%): 95.0% (38/40) of patients in the TDF monotherapy group and 96.8% (61/63) of patients in the TDF–LAM combination therapy group. The VR rates were not significantly different between the TDF monotherapy and TDF–LAM combination therapy groups (88.9 vs. 87.3% at month 12, and 94.4 vs. 93.7% at month 24, log-rank p=0.652). Univariate and multivariate analyses revealed that none of the pretreatment factors were significantly associated with VR. Conclusions:TDF monotherapy was as effective as TDF–LAM combination therapy for maintaining viral suppression in the vast majority of patients with LAM-resistant CHB, which suggests that TDF add-on therapy with LAM is unnecessary.
Antecedentes/Objetivos: El fumarato de disoproxilo de tenofovir (TDF) muestra una eficacia antiviral similar frente a la hepatitis B crónica (HBC) tanto en pacientes sin tratamiento previo como en aquellos con resistencia a la lamivudina (LAM). Sin embargo, existen escasos informes clínicos sobre los efectos antivirales de la terapia combinada de TDF-LAM en comparación con la monoterapia con TDF en pacientes con HBC resistente a LAM. Métodos: Se investigó la eficacia antiviral de la monoterapia con TDF frente a la terapia combinada de TDF-LAM en 103 pacientes con HBC resistente a LAM. Resultados: Los sujetos del estudio fueron tratados con TDF en monoterapia (n=40) o con terapia combinada de TDF-LAM (n=63) durante ≥6 meses. Los pacientes habían recibido previamente una terapia de rescate basada en TDF durante una mediana de 30,0 meses (rango: 8-36 meses). Se alcanzó una respuesta virológica (RV) en 99 pacientes (96,1 %): el 95,0 % (38/40) de los pacientes en el grupo de monoterapia con TDF y el 96,8 % (61/63) de los pacientes en el grupo de terapia combinada de TDF-LAM. Las tasas de RV no difirieron significativamente entre los grupos de monoterapia con TDF y de terapia combinada de TDF-LAM (88,9 frente a 87,3 % en el mes 12, y 94,4 frente a 93,7 % en el mes 24; log-rank p=0,652). Los análisis univariados y multivariados revelaron que ninguno de los factores previos al tratamiento se asoció significativamente con la RV. Conclusiones: La monoterapia con TDF fue tan eficaz como la terapia combinada de TDF-LAM para mantener la supresión viral en la gran mayoría de los pacientes con HBC resistente a LAM, lo que sugiere que la adición de LAM a la terapia con TDF es innecesaria.
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Authors ;Chan Ho Park;Seok Won Jung;Jung Woo Shin;Mi Ae Bae;Yoon Im Lee;Yong Tae Park;Hwa Sik Chung;Neung Hwa Park
Journal american journal of clinical oncology
Year 2016
DOI
10.3350/cmh.2016.22.1.152
URL
http://e-cmh.org/upload/pdf/cmh-22-1-152.pdf
Keywords
resistance Gastroenterology

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