studies of promising therapies by unbiased investigators. We trust that Drs. Christmas and Finucane would agree. David B. Reuben, MD Gail A. Greendale, MD Multicampus Program in Geriatric Medicine and Gerontology David Geffen School of Medicine University of California at Los Angeles Los Angeles, CA ACKNOWLEDGMENT Financial Disclosure: Funding for the original study is from Bristol Myers Squibb Immunology. Gail A. Greendale is a consultant for Wyeth-Ayerst. Author Contributions: David B. Reuben and Gail A. Greendale both took part in the preparation of this letter. Sponsor’s Role: None. ARE ELDERLY PATIENTS POOR CANDIDATESFOR PEGYLATED INTERFERON PLUS RIBAVIRIN IN THE TREATMENT OF CHRONIC HEPATITIS C? To the Editor: The National Institutes of Health consensus conference on hepatitis C defines elderly patients with chronic hepatitis C as a difficult group to treat, and no standard guidelines have been published so far for this par- ticular age group. 1 Only three uncontrolled trials with in- terferon (IFN) monotherapy in older people have been reported, 2–4 and the sample size in each study was small, ranging from 21 to 25 subjects. In all these trials, the authors found no difference in the prevalence of adverse effects be- tween older and younger patients. Only one of the studies 5 evaluated the sustained response, which was much the same in subjects younger than 60 as in subjects aged 60 and older (26% vs 33%). There are no reports on the treatment of older people with pegylated IFN and ribavirin (RBV). Thirty-three naı ¨ve patients with chronic hepatitis C (25 women, 8 men) with a mean age Æ standard deviation of 70.2 Æ 1.2 were consecutively enrolled to receive pegylated IFN a-2b at a dose of 1.5 mg/kg weekly plus a RBV dose of at least 10.6 mg/kg per day for 6 (genotype 2 or 3) or 12 (genotype 1 or 4) months. Tolerance and efficacy were compared with those ob- served in a 1:2 adult group (66 subjects, aged 45.2 Æ 8.9) matched for sex, genotype, viral load, and grading/staging parameters. All subjects gave their informed consent, and the local ethical committee approved the study. All subjects were treated for at least 24 weeks and, in the event of ne- gativization of hepatitis C virus ribonucleic acid (HCV- RNA), for 52 weeks. Early virological response (EVR) was defined as the absence of detectable HCV-RNA using PCR after the 4th week of treatment. Sustained virological response (SVR) was defined as the absence of detectable HCV-RNA 24 weeks after completing the treatment. Patients who failed to achieve a HCV-RNA reduction of at least 2 logs after the first 12 weeks of treatment were defined as nonresponders. The likelihood of SVR for each patient was determined using intention-to-treat analysis. Differences in baseline characteristics between the groups were compared using the chi-square test for dichotomous variables and the two-sided t test for continuous variables. Response rates were com- pared using chi-square analysis. The proportion of side effects leading to discontinua- tion of therapy was higher in elderly patients (24.2%) than in younger adults (12.2%), although the difference lacked statistical significance. All adverse effects except depression disappeared spontaneously within 2 to 3 weeks of discon- tinuing the treatment; the younger adult patients recovered completely from depression within 2 months, whereas the elderly patients required pharmacological therapy with trazodone (50 mg twice a day) for 3 months. The proportion of patients who reached EVR was sig- nificantly higher for the younger adults than for the elderly patients (80.3% vs 54.5%, Po.002) (Table 1). Similarly, the proportion of patients reaching a virological response at the end of treatment was significantly higher in younger adults than in older people (83.3% vs 54.5%, P o .002), and SVR was 69.7% in younger adults and 45.5% in elderly patients (P o .02). The percentage of relapsers did not dif- fer statistically between the two groups. The problem of whether to offer antiviral treatment to a wide range of patients has arisen over the last 7 to 8 years, since the reduction in the risk of hepato-cellular carcinoma was analyzed. It is generally agreed in the literature that patients responding to IFN therapy have a lower risk of hepato-cellular carcinoma, 5,6 so in terms of cost/benefit, every patient with chronic hepatitis C should be considered as a potential candidate for antiviral therapy. A 45% rate of SVR in elderly patients should be considered a good result, even though it is significantly lower than in younger adults. This is the same rate as the one reported by a previous study in 20 patients aged 65 and older treated with IFN and RBV. 7 The most important decision-making matter is the high rate of side effects in elderly patients. We failed to demonstrate a significantly higher percentage of adverse effects in older people than in younger adults, but this is probably because of our careful patient selection; an accurate monitoring of symptoms and biochemical parameters (including the he- matological profile) is recommended. In conclusion, elderly patients with chronic hepatitis C receiving combined treatment with IFN and RBV have a higher likelihood of side effects and a significantly lower rate of virological response at the end of the treatment and 6 months afterward than younger adults. Cost-benefit anal- Table 1. Response to Viral Therapy Response Elderly Younger Adult P-value n (%) Early virological response 18 (54.5) 53 (80.3) .002 No response 7 (21.2) 3 (4.5) .001 Virological response (end of treatment) 18 (54.5) 55 (83.3) .002 Relapse 3 (9.1) 9 (13.6) * Sustained virological response 15 (45.5) 46 (69.7) .02 *Not significant. LETTERS TO THE EDITOR 549 JAGS MARCH 2006–VOL. 54, NO. 3