The likelihood of a sustained response to a course of interferon in patients with chronic hepatitis C correlates with several clinical and viral factors, including age, viral genotype and initial levels of hepatitis C virus (HCV) RNA in serum. The role of race and ethnicity has not been assessed. We evaluated the association of race with response to interferon in a large randomized, controlled trial using either consensus interferon (9 g) or interferon alfa-2b (3 million units) given three times weekly for 24 weeks. African-American patients participating in the study were similar to white patients in mean age (43 vs. 42 years) and baseline levels of HCV RNA (3.6 vs. 3.0 million copies/mL) but had lower rates of cirrhosis (5% vs. 12%) and more frequently had viral genotype 1 (88% vs. 66%: P ‫؍‬ .004). Most strikingly, the rates of end-of-treatment and sustained virological responses were lower among the 40 African-American patients (5% and 2%) than among the 380 white patients (33% and 12%) (P ‫؍‬ .04 and .07). Rates of response among Hispanic and Asian-American patients were not statistically different than non-Hispanic white patients. Median viral levels decreased by week 24 of therapy by 2.5 logs in white patients (from 3.0 to 0.012 million copies/mL) but by only 0.5 logs among AfricanAmerican patients (from 3.6 to 1.8 million copies/mL). Thus, there are marked racial differences in virological responses to interferon in hepatitis C that must be considered in assessing trials of interferon therapy and in counseling patients regarding treatment. The differences in response rates are as yet unexplained. (HEPATOLOGY 1999;30: 787-793.)

Unselected patients with advanced NSCLC and PS 2 are best treated with combination chemotherapy as first-line therapy. Erlotinib may be considered in patients selected by clinical or molecular markers.

A multicenter, open-label, phase 3 study was conducted in 337 patients with chronic hepatitis C virus (HCV) infection who had either not responded to previous interferon therapy or had relapsed after discontinuation of therapy with either consensus interferon (9 g) or interferon ␣-2b (3 million U) three times a week for 24 weeks. Patients were randomized to receive a higher dose of consensus interferon (15 g) administered subcutaneously three times a week for 24 or 48 weeks and then were observed for an additional 24 weeks. Patients who had relapsed after prior interferon therapy were more likely to have a sustained alanine aminotransferase response and HCV RNA response (as measured by reverse transcriptionpolymerase chain reaction with a sensitivity of F100 copies/mL) than were patients who had not responded to prior interferon therapy. For relapsers, the sustained HCV RNA response rate was 58% (48 weeks) and 28% (24 weeks). The sustained alanine aminotransferase response for relapsers was 52% (48 weeks) and 39% (24 weeks). The sustained HCV RNA response rate among prior nonresponders was 13% (48 weeks) and 5% (24 weeks), and the sustained alanine aminotransferase response rate for nonresponders was 17% (48 weeks) and 12% (24 weeks). The administration of 15 g of consensus interferon was well tolerated and was not associated with an increase in the incidence of side effects. These data demonstrate that re-treatment with 15 g of consensus interferon is safe and effective therapy for patients with chronic hepatitis C who have either not responded to previous interferon therapy or relapsed after discontinuation of interferon therapy. (HEPA-TOLOGY 1998;27:1136-1143.)Hepatitis C virus (HCV) is the most common cause of non-A, non-B viral hepatitis in the world. 1,2 The disease is insidious, and the majority of patients do not develop jaundice at its onset. 3,4 HCV is a major public health concern because of its propensity to progress to chronic hepatitis, cirrhosis, and hepatocellular carcinoma. 5,6 The mechanism for viral persistence is unknown because HCV is an RNA virus that is not integrated into the host genome. 7 One potential explanation for the high rate of chronic infection is that HCV escapes immunologic surveillance because of its high spontaneous mutation rate, which has been estimated at 10 Ϫ2 mutations/nucleotide/year. 8 The current approved therapies for hepatitis C in the United States consist of the alpha interferons. 9,10 These are a family of cytokines with antiviral and immunomodulatory properties. 11,12 However, less than half of patients treated with alpha interferons do not respond to treatment, and of those who demonstrate a response, up to approximately two thirds will relapse within 6 months of discontinuing therapy. 13,14 Thus, the overall sustained alanine transaminase (ALT) response rate to alpha-interferon therapy is approximately 15% to 20%. 10 Consensus interferon (CIFN; Amgen Inc., Thousand Oaks, CA) is a genetically engineered molecule derived by assigning the most commonly observed ...