RESUMEN
OBJECTIVE: Treatment of hepatitis C virus (HCV) with interferon-based therapy has been shown to be less effective in Hispanics when compared to other populations. A pilot clinic was established at the University of Puerto Rico for the treatment of HCV in the government-insured population. The aim of this study was to describe the outcomes and treatment response to pegylated interferon and ribavirin in treatment-naive patients enrolled at this government-sponsored clinic. METHODS: A retrospective analysis was undertaken to investigate the treatment outcomes with weight based peg-interferon-alpha-2b and ribavirin in patients with chronic HCV enrolled in the pilot clinic during 2003-2005. Descriptive statistics were reported. Continuous variables were summarized as means and standard deviations. Frequency distributions and percents were used for categorical variables. Statistical analysis was performed using STATA. RESULTS: A total of 155 patients (105 males and 50 females) with mean age of 42 years started treatment; 79 (51%) patients had HCV genotype 1. Completion of treatment was achieved by 59 patients (38.1%), of whom end of treatment response (ETR) was observed in 30 (50.9%), representing 19.4% of the intention-to-treat population (ITT). Sustained viral response (SVR) was achieved in 17 (28.8%) patients who completed treatment, resulting in 11% (17/155) SVR by ITT. The only significant predictor of SVR was treatment onset within 5 years of the diagnosis of HCV (p = 0.026). Although no association was found between HCV genotype and SVR (p = 0.192), those patients with HCV genotypes 2 and 3 were more likely to complete treatment (p = 0.009). CONCLUSION: SVR to pegylated interferon and ribavirin seems to be lower than expected in our population. The high rate of incomplete treatment surpasses previously reported rates in U.S. Latinos and Caucasians. Further studies should explore reasons for lower response and higher treatment discontinuation in our population.
Asunto(s)
Antivirales/uso terapéutico , Hepatitis C Crónica/tratamiento farmacológico , Hispánicos o Latinos , Interferón-alfa/uso terapéutico , Polietilenglicoles/uso terapéutico , Ribavirina/uso terapéutico , Adolescente , Adulto , Femenino , Programas de Gobierno , Instituciones de Salud , Humanos , Interferón alfa-2 , Masculino , Área sin Atención Médica , Persona de Mediana Edad , Puerto Rico , Proteínas Recombinantes , Estudios Retrospectivos , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: Chronic hepatitis C (CHC) is a major health problem in Puerto Rico (PR). More than 50% of the population is insured by a government-sponsored managed care system that does not cover treatment for CHC. Lack of access to treatment will result in an increase in end-stage liver disease with its high socioeconomic impact in the future. In an attempt to identify strategies for the treatment of CHC in the publicly insured population, the PR Health Department and the University of Puerto Rico (UPR) Gastroenterology (GI) Division have developed a pilot clinic for the evaluation and treatment of CHC. METHODS: UPR and the PR Health Department negotiated a fee per patient to include all medical care and follow-up laboratories. Viral studies were covered by a grant to the Health Department. Medications were bought at a discount price by the government and dispensed at a government pharmacy. The Health Department allocated funds for 200 patients with government insurance. A dedicated clinic was established at the UPR, staffed by an internist under the supervision of the GI faculty. Patients with a positive HCVab were referred to this clinic. The public insurance covered the CBC, liver tests, metabolic panel, TSH, HBsAg, HIV, ultrasound and liver biopsy, which were required prior to evaluation for possible treatment. In the initial visit, patients underwent a medical evaluation, including assessment of suitability for therapy and counseling. Those deemed to be candidates who still needed a liver biopsy had it performed by the GI staff. Genotype and viral titers were ordered after the decision on treatment had been made. The clinic physician prescribed pegylated interferon and ribavirin, which were dispensed by the government pharmacy. Instruction on proper drug administration was given. Clinic visits were scheduled for 1, 3, 6 and 12 months but also allowed on demand. Laboratory tests were done at the clinic and reviewed by the physician expediently to monitor for toxicity. Any medical problems or treatment for complications of therapy were covered by the primary insurer. Viral load was repeated at 12 weeks to discontinue therapy in those unlikely to respond. The budget per patient for medical visits and laboratory tests was dollars 1,500.00, HCV RNA titers plus genotype costs dollars 200.00, and HCV qualitative RNA costs dollars 123.00 RESULTS: 405 patients have been referred between February 2002 and April 2003 (the number was increased at adjust for no-shows and those not treated). 30% are female, the major risk factor is IVDU, and 80% are unemployed. 101 have started treatment and 48 are awaiting biopsy. A support group has been established at the clinic. CONCLUSIONS: The treatment for CHC in practice is not only costly but also resource consuming. Most gastroenterologists in our community refer these patients for treatment. The establishment of a dedicated clinic with a primary physician supervised by the specialists reduces costs and facilitates caring for a larger number of patients. The volume of services allows for negotiation of medical, laboratory and drug costs. In allocating funds for this project, the PR Health Department recognized the importance in reducing the potential spread in the community by treating infected patients as well as reducing the future medical and socioeconomic burden of end-stage liver disease. Although the outcome of this project is still unseen, we believe that this model may serve to establish other clinics for the treatment of CHC at lower costs with the same effectiveness.