The benefits of a public pharmacist service in chronic hepattis C treatment: The real-life results of sofosbuvir-based therapy.

BACKGROUND: In Brazil, the sofosbuvir-based therapy was introduced in the public health system (SUS) in 2015 to treat Chronic Hepatitis C (CHC). This drug and other direct-acting antiviral agents (DAAs) represent a major advance in the HCV-infection treatment due to their high effectiveness and tolerability. However, the drug safety profile is limited by significant drug interactions and its use is restricted for their high cost. Pharmacists have the opportunity to improve patient care by monitoring the therapy, recommending strategies to guarantee treatment adherence, effectiveness and safety, preventing complications of the disease, and drug-related problems, thus reducing the cost for patients and payers. OBJECTIVE: This study aimed to assess the results of the one of the first patient group treated with sofosbuvir in Brazil and their opinions about the benefits of clinical pharmacist services in the achievement of the cure for CHC and in the management of their therapy difficulties. METHODS: This cohort study (November 2015-January 2017) enrolled 240 patients followed up by the clinical pharmacists at the University Pharmacy (UPh) of the Federal University of Santa Catarina, Brazil, during the CHC treatment. The therapeutic schemes used were sofosbuvir + daclatasvir or + simeprevir associated or not with ribavirin. At the end of the therapy, the patients provided qualitative feedback about the clinical pharmacist services. RESULTS: The study demonstrated high levels of treatment adherence (99.2% of completion rates) and effectiveness rates (Sustained Virological Response rates) (92.1%). Patients reported high levels of satisfaction with the care provided on account of the good rapport built with their pharmacist, the counseling and education on HCV-infection and on sofosbuvir-based therapy utilization, motivation for adherence, and convenient access to the pharmacist. CONCLUSIONS: The clinical pharmacist services provided by the UPh was beneficial to patients treated for CHC with the sofosbuvir-based therapy.

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.

Sustained virological response to treatment of chronic hepatitis C with peginterferon alfa and ribavirin

This study aimed to evaluate the rate of sustained virological response (SVR) and the clinical and treatment characteristics of patients with chronic hepatitis C (CHC). A retrospective uncontrolled cohort study was conducted among patients who received treatment for CHC between 2005 and 2008 attended at the Center for the Application and Monitoring of Injectable Medications, in Florianopolis, SC, Brazil. The inclusion criteria were: patients over 18 years of age, with a confirmed diagnosis of chronic hepatitis C according to Brazilian guidelines, treated with PEG-IFN alfa-2a or 2b associated with RBV. A total of 188 patients were included in the study: 70% men, 59% genotype 1, 27% coinfected with HIV, 31% with cirrhosis. The SVR rate, calculated by probability theory, was determined as 26% (max=57.4% and min=12.8%) and the intention to treat was 12.8%. Associations between Sustained Virological Response (SVR) and the variables sex (p=0.017), age (p=0.003), genotype (p=0.648) and cirrhosis (p=0.275), were determined in the bivariate analysis and only sex and age were significantly associated with SVR. The SVR rate was considered low, which can be partially explained by patients' unfavorable pretreatment characteristics.

O objetivo do estudo foi avaliar a taxa de resposta viral sustentada (RVS) e as características clínicas e do tratamento dos pacientes portadores de hepatite C crônica. Realizou-se uma coorte retrospectiva não controlada com recorte temporal dos anos de 2005 a 2008, dos pacientes atendidos no Polo de Aplicação e Monitoramento de Medicamentos Injetáveis, em Florianópolis, SC. Os critérios de inclusão foram: pacientes maiores de 18 anos, com diagnóstico confirmado de hepatite C crônica de acordo com o protocolo brasileiro, tratados com PEG-IFN alfa-2a ou 2b associado a ribavirina. Total de 188 pacientes foi incluído no estudo, 70% homens, 59% genótipo 1, 27% co-infectados com o HIV e 31% apresentando cirrose. A taxa de RVS calculada através da teoria das probabilidades foi de 26% (max=57,4% and min=12,8%) e por intenção de tratamento de 12,8%. Verificou-se a associação da RVS com as variáveis: sexo (p=0,017), idade (p=0,003), genótipo (p=0,648) e presença de cirrose (p=0,275). Somente sexo e idade foram associados significativamente com a RVS. A taxa de RVS foi considerada baixa e, em parte, pode ser explicada pelas características desfavoráveis dos pacientes para a obtenção de RVS.