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Hepatitis C Virus and Human Immunodeficiency Virus Coinfection in an Urban Population: Low Eligibility for Interferon Treatment
  One hundred eighty human immunodeficiency virus (HIV) and hepatitis C virus (HCV)coinfected patients were prospectively evaluated for suitability for interferon and ribavirin therapy. Of the 149 patients with chronic HCV infection who completed the evaluation, 44 (30%) were eligible for treatment and 105 (70%) were ineligible, with the main barriers being missed clinic visits, active psychiatric illness, active drug or alcohol use, decompensated liver disease, or medical illness.. These barriers persisted despite ongoing education regarding the seriousness of HCV disease and access to a designated psychiatrist and substance abuse programs ..... These data underscore the challenges that exist in treating HCV disease in an urban population of HCV- and HIV-coinfected patients. Of interest, 14% of the patients referred were HCV RNA negative, similar to the general population... Decompensated liver disease was seen in 13% at presentation, reinforcing the prevalence of liver-related morbidity in HCV- and HIV-coinfected patients.
Because the majority of coinfected patients have a history of injection drug use, we believe that our results are generalizable to other urban populations with injection drug use as a risk factor. Interestingly, our findings are remarkably similar to the results of Falck-Ytter et al. [1; see end of this report], who reported that only 28% of urban patients with HCV infection alone were eligible for HCV therapy.
Clinical Infectious Diseases, 2003;36:97-100, Jan 2003 Catherine A. Fleming, Donald E. Craven,a David Thornton, Sheila Tumilty, and David Nunes. Boston Medical Center, Boston University School of Medicine, Boston, Massachusetts
Article Excerpts
Coinfection with hepatitis C virus (HCV) and HIV is increasingly recognized as a public health problem in the United States. About 30% of HIV-infected patients are coinfected with HCV, with the highest prevalence in injection drug users. HIV is a risk factor for accelerated HCV disease, and liver disease has emerged as a major cause of mortality and morbidity in coinfected patients. Combination therapy with pegylated IFN and ribavirin is the current standard of care for chronic HCV infection, with sustained response rates of about 50%. The objectives of this study were therefore to prospectively evaluate coinfected patients' suitability for HCV therapy with IFN and ribavirin and to identify barriers to treatment among this population.
About 1250 HIV-infected patients receive primary care at Boston Medical Center, of whom 55% are HCV-coinfected. A designated consult clinic, staffed by infectious disease and hepatology specialists, was established to evaluate coinfected patients for HCV treatment. Patients were referred by their primary care providers and underwent a standardized evaluation, comprising patient history, physical examination, and laboratory tests, which included determination of HCV RNA level, complete blood count, measurement of serum creatinine level, random blood sugar test, liver function tests, and coagulation studies. If HCV RNA was detectable, genotype was determined and a liver ultrasound was obtained. Patients without absolute contraindications for treatment were encouraged to undergo liver biopsy for disease staging; however, this was not required.
Baseline eligibility criteria for HCV treatment were detectable serum HCV RNA and elevated serum aminotransferase levels within the previous 12 months. Exclusion criteria included nonadherence (missing >3 clinic appointments), ongoing alcohol or drug use (other than marijuana) in the preceding 6 months, active psychiatric illness (defined as symptomatic psychosis or depression or a suicide attempt within the previous year), active medical illness (defined as ongoing illness that is a contraindication to IFN therapy or is associated with a life expectancy of <3 years), decompensated liver disease (defined as a Child Pugh score of >7), advanced HIV disease (defined as a CD4 cell count of <100 cells/mm3 regardless of HIV load or count of 100-200 cells/mm3 with HIV load of >10,000 copies/mL), neutrophil count of <1.5 x 109 cells/L, and platelet count of <75 x 109 cells/L.
Patients who were not treatment candidates were reevaluated after 6 months, and their treatment eligibility reassessed. All patients received a comprehensive education program during their initial clinic visits, and onsite addiction counseling was available, with referral to methadone and drug rehabilitation programs. Psychiatric consultation was obtained for all patients with a history of, or symptoms suggestive of, ongoing psychiatric illness. Each patient's eligibility for HCV therapy was evaluated jointly by the attending infectious disease and hepatology staff by use of the above criteria.
From 1 January 2000 to 1 February 2002, 180 HCV- and HIV-coinfected patients were referred for evaluation; 173 completed the evaluation and are included in this study. Twenty-four patients (14%) had undetectable HCV RNA and were considered to have inactive HCV infection. Of the 149 patients with chronic HCV infection, 44 (29%) were considered to be eligible for HCV therapy (table 1). Fifty-five patients (37%) underwent liver biopsy, 23 of whom were subsequently considered to be ineligible for HCV therapy because of intercurrent medical issues, psychiatric illness, relapsed drug or alcohol use, or failure to follow up in clinic. Twelve otherwise eligible patients refused liver biopsy, 3 of whom subsequently commenced treatment. The eligible patients were significantly more likely to have CD4 cell counts of >200 cells/mm3 and HIV loads of <50 copies/mL and to be infected with HCV genotype other than 1; however, there were no other differences in laboratory values or demographics.
Of the 44 chronically infected patients who were assessed as appropriate for HCV therapy, 28 (64%) decided not to proceed. Reasons for not starting treatment were potential side effects for 9 patients (8 of whom had minimal fibrosis on liver biopsy), unstable social circumstances for 3 patients, concerns about ability to work for 3 patients, and worry about relapse of injection drug use for 2 patients. One patient's wife became pregnant, and 1 patient died of an unrelated cause. Six patients did not return to the clinic after discussing therapy, and 3 patients relocated. Sixteen patients (36%) commenced HCV treatment, 8 (50%) of whom were infected with genotypes 2, 3, or 4, compared with a 24% prevalence of these genotypes overall.
One hundred five patients (70%) were considered to be ineligible for HCV therapy. The major barriers included nonadherence with medical visits for 24 patients (23%), active psychiatric disease for 22 patients (21%), drug or alcohol use in the previous 6 months for 24 patients (23%), decompensated liver disease for 13 patients (12%), advanced HIV disease for 14 patients (13%), and medical comorbidities for 8 patients (8%). The latter group included poorly controlled diabetes, cardiac disease, anemia, Hodgkin's disease, and end-stage renal disease.
Our study may have overestimated the proportion of eligible patients among all inner-city coinfected persons, because primary care physicians tended to refer patients they perceived as good candidates, thus introducing referral bias. However, the proportion of patients with severe liver disease may also be an overestimate, because patients with severe liver disease were also more likely to have been referred. The fact that the majority of these patients had well-controlled HIV disease, evidenced by the fact that >40% had an undetectable HIV load, reinforces that fact that even for those patients adhering to HIV treatments, embarking on HCV treatment may pose a significant challenge. Patients with nonHCV genotype 1 disease were more likely to commence treatment, indicating that the poor response and longer duration of therapy in HCV genotype 1infected patients are also perceived as being significant barriers.
1. Ann Intern Med. 2002 Dec 17;137(12):1012. "Surprisingly small effect of antiviral treatment in patients with hepatitis C" Falck-Ytter. German Cochrane Institute, Stefan-Meier-Strasse 26, 79104 Freiburg, Germany.
BACKGROUND: The effect and applicability of interferon-based antiviral therapies in the general population of persons with hepatitis C virus (HCV) infection are unknown. OBJECTIVE: To determine the applicability and usefulness of anti-viral therapy in a metropolitan clinic population. DESIGN: Retrospective case series of consecutively referred patients. SETTING: A teaching county hospital in Cleveland, Ohio. PATIENTS: 327 patients referred to a liver clinic after a positive result for antibody against HCV on enzyme-linked immunosorbent assay (ELISA). MEASUREMENTS: Treatment rates; reasons for nontreatment. RESULTS: 34 patients had no detectable HCV RNA. Of the remaining 293 patients, 72% were not treated for the following reasons: 37% did not adhere to evaluation procedures, 34% had medical or psychiatric contraindications, 13% had ongoing substance or alcohol abuse, 11% preferred no treatment, and 5% had normal liver enzyme levels. Only 83 patients (28%) were treated; 13% had a sustained viral response. CONCLUSION: Most patients with HCV infection are not candidates for interferon-based therapies; alternative interventions should be sought for these patients.
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