Hepatitis C in Brazil: lessons learned with boceprevir and telaprevir.

In 2012, the first-generation protease inhibitors telaprevir (TVR) and boceprevir (BOC) were introduced in the Brazilian health system for treatment of chronic hepatitis C, after their approval by the National Committee for Health Technology Incorporation (CONITEC). However, these medicines were discontinued in 2015. The short period of use in therapy and their high cost require a discussion about the consequences for patients and for the health system of the early incorporation of new therapies. The article presents a qualitative analysis of the incorporation process of both medications in Brazil and the results of a multicenter study that included patients treated with BOC or TVR between January 2011 and December 2015 in five Brazilian cities. The study included 855 patients (BOC: n=247) and (TVR: n=608). The document analysis showed that CONITEC's decision to incorporate BOC and TVR was based on results of phase III clinical trials that compared sustained virologic response (SVR) rates of patients treated with BOC and TVR with rates of those that received placebo. However, these studies included a low percentage of cirrhotic patients. The SVR rates observed in this multicenter study were worse than clinical trials pointed out (BOC: 45.6%; TVR: 51.8%), but similar to those achieved with previously adopted therapies. The discontinuation rate due to adverse events was (BOC: 15.4%; TVR: 12.7%). Based on these unsatisfactory results, the study brings a discussion that goes beyond the therapy outcomes, exploring the incorporation of these high-cost medicines and the related decision-making process, contributing to future decisions in medicine policies and in the treatment of chronic hepatitis C.

Curing Chronic Hepatitis C: A Cost Comparison of the Combination Simeprevir Plus Sofosbuvir vs. Protease-Inhibitor-Based Triple Therapy

ABSTRACT Introduction. Interferon-free, multi-direct acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection is highly effective and well tolerated, but costly. To gain perspective on the evolving economics of HCV therapy, we compared the cost per cure of a multi-DAA regimen with the prior standard of triple therapy. Material and methods. Patients infected with HCV genotype 1 who were treated through the University of Colorado Hepatology Clinic between May 2011 and December 2014 comprised the study population. The multi-DAA regimen of simeprevir plus sofosbuvir (SMV/SOF) was compared to the triple therapy regimen consisting of peginterferon and ribavirin, with either boceprevir or telaprevir (TT). Sustained-virologic response (SVR) rates, total costs per treatment and adverse events were recorded. Total cost per SVR were compared for the two treatments, controlling for patient demographics and clinical characteristics. Results. One hundred eighty-three patients received SMV/SOF (n = 70) or TT (n = 113). Patients receiving SMV/SOF were older, more treatment experienced, and had a higher stage of fibrosis. SVRs were 86% and 59%, average total costs per patient were $152,775 and $95,943, and average total costs per SVR were $178,237 vs. $161,813.49 for SMV/SOF and TT groups, respectively. Medication costs accounted for 98% of SMV/SOF and 85% of TT treatment costs. Conclusion. The high cure rate of multi-DAA treatment of HCV is offset by the high costs of the DAAs, such that the cost per cure from TT to multi-DAA therapy has been relatively constant. In order to cure more patients, either additional financial resources will need to be allocated to the treatment of HCV or drug costs will need to be reduced.

Curing Chronic Hepatitis C: A Cost Comparison of the Combination Simeprevir Plus Sofosbuvir vs. Protease-Inhibitor-Based Triple Therapy.

INTRODUCTION: Interferon-free, multi-direct acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection is highly effective and well tolerated, but costly. To gain perspective on the evolving economics of HCV therapy, we compared the cost per cure of a multi-DAA regimen with the prior standard of triple therapy. MATERIAL AND METHODS: Patients infected with HCV genotype 1 who were treated through the University of Colorado Hepatology Clinic between May 2011 and December 2014 comprised the study population. The multi-DAA regimen of simeprevir plus sofosbuvir (SMV/SOF) was compared to the triple therapy regimen consisting of peginterferon and ribavirin, with either boceprevir or telaprevir (TT). Sustained-virologic response (SVR) rates, total costs per treatment and adverse events were recorded. Total cost per SVR were compared for the two treatments, controlling for patient demographics and clinical characteristics. RESULTS: One hundred eighty-three patients received SMV/SOF (n = 70) or TT (n = 113). Patients receiving SMV/SOF were older, more treatment experienced, and had a higher stage of fibrosis. SVRs were 86% and 59%, average total costs per patient were $152,775 and $95,943, and average total costs per SVR were $178,237 vs. $161,813.49 for SMV/SOF and TT groups, respectively. Medication costs accounted for 98% of SMV/SOF and 85% of TT treatment costs. CONCLUSION: The high cure rate of multi-DAA treatment of HCV is offset by the high costs of the DAAs, such that the cost per cure from TT to multi-DAA therapy has been relatively constant. In order to cure more patients, either additional financial resources will need to be allocated to the treatment of HCV or drug costs will need to be reduced.

Importancia de la evaluación económica en los tratamientos antirretrovirales para el VIH/SIDA / Importance of the economic evaluation in the antiretroviral treatments for HIV/AIDS

Se realizó una investigación bibliográfica sobre los estudios de evaluación económica en los tratamientos antirretrovirales para el VIH/SIDA en el ámbito internacional, que permita valorar los beneficios económicos y sociales en términos de salud para el paciente, y compararlos con el monto económico de los recursos farmacéuticos utilizados en el tratamiento global de esta enfermedad. Así, se podrá obtener los niveles de eficiencia farmacoterapéutica requeridos, que justifiquen la utilización de los medicamentos en los presupuestos de salud de todos los países que requieran combatir a esta pandemia a escala mundial. Por esta razón, la farmacoeconomía aplicada al campo de la farmacoterapia para el VIH/SIDA, es considerada como un elemento más que contribuye a mejorar la prescripción racional de los antirretrovirales, lo cual implica una consideración del empleo eficiente de los recursos sanitarios. El gasto en los tratamientos con antirretrovirales es cuantioso, pero su valoración en términos de eficiencia permite conocer las combinaciones más efectivas y mejor toleradas para la salud del paciente, definiendo las mejores estrategias de tratamiento y en qué forma están influidas por los cambios en la carga viral y por la aparición de las resistencias. Es por ello, que el uso racional y eficiente de los antirretrovirales posibilita una disminución en el consumo de recursos hospitalarios a expensas de una reducción de las estancias, así como un evidente beneficio del descenso de la morbilidad y mortalidad de los pacientes tratados con estos medicamentos. Como se demuestra en esta revisión bibliográfica, los resultados obtenidos en los estudios farmacoeconómicos internacionales indican que los tratamientos antirretrovirales, fundamentalmente la terapia sumamente activa, tiene una buena relación costo-efectividad y debería ser ofrecida a todos los casos VIH/SIDA que pudieran beneficiarse de ella, dado el evidente indicio de los efectos beneficiosos demostrados por esta farmacoterapia, tanto desde el punto de vista económico como en los resultados clínicos, inmunológicos y virológicos sobre los pacientes(AU)