Treatment Outcomes to Peg-Interferon and Ribavirin in a Government Sponsored Clinic for an Underserved Population with Chronic Hepatitis C

Abstract

Purpose: Recent studies have revealed a lower HCV treatment response and a higher treatment discontinuation rate in Hispanics compare to Caucasians. HCV treatment is not covered by the Puerto Rico government health care system. A pilot government-sponsored clinic was established at the University of Puerto Rico for the treatment of this underserved population. The aim of this study is to describe the outcomes and treatment response of Peg-interferon and Ribavirin in treatment-naïve chronic HCV patients in this clinic. Methods: A retrospective analysis to investigate the outcomes of HCV patients treated with Peg-interferon and Ribavirin in a pilot clinic during 2003–2005. Frequencies and percentages to summarize patient's groups and Fisher's exact test to analyze the distribution of all groups were used. Results: 156 (106 M:50 F, mean age 41.9) patients started treatment. Genotype 1 was found in 72.4%. Treatment was discontinued in 47 (30%): 24 (51%) were early non-responders, 16 (34%) had adverse effects, 5 (10.7%) developed co-morbidities during treatment, 2 (4.3%) had unrelated deaths. Another 46 patients (29.5%) were lost to follow-up after having started treatment. Sixty-three patients (40.4%) completed treatment. When patients with an early discontinuation are excluded, 37/63 (58.7%) had End-of-treatment response (ETR), while the ETR on those intended to treat was 23.7%. Recurrence of viremia was observed in 5/37 (13.5%) of those with ETR. Sustained viral response (SVR) was seen in 16/63 (25.4%) patients who completed treatment, while the SVR on those intended to treat was 16/156 (10.3%). Sixteen of 37 (43.2%) patients were lost to follow up to assess SVR. No significant correlation was found between ETR and age, gender, viral genotype, initial HCV RNA, early virological response, or degree of fibrosis (p > 0.05). Conclusions: The high rate of treatment discontinuation in our population surpasses the previously reported rates in U.S. Latinos and Caucasians. Treatment response to Peg-interferon and Ribavirin seems to be lower in our population. The pilot clinic for treatment of HCV did not fullfill its goals. Quality of life assessment, clinic coordinator, treatment of side effects and educational material should be provided to improve patient compliance and decrease rate of discontinuation. Further studies should assess reasons for higher treatment discontinuation in Hispanics.