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ALT Flare (alt + flare)
Selected AbstractsSerum alanine aminotransferase flares during interferon treatment of chronic hepatitis B: Is sustained clearance of HBV DNA dependent on levels of pretreatment viremia?HEPATOLOGY, Issue 5 2001Satheesh Nair During interferon treatment of chronic hepatitis B, an alanine aminotransferase (ALT) flare may herald a sustained loss of viral replication, but the relationship between virologic response, the extent of a flare, and pretreatment hepatitis B virus (HBV) DNA level has not been defined. We retrospectively examined the impact of an ALT flare on sustained virologic response in 121 interferon-treated patients and 42 untreated controls with either low-level (<100 pg/mL) or high-level (,100 pg/mL) viremia. The degree of ALT flare was classified as mild (increase in ALT of 86-171 IU/L above baseline), moderate (increase of 172 to 343 IU/L above baseline), and severe (increase of ,344 IU/L above baseline). Undetectable serum HBV DNA and hepatitis B e antigen (HBeAg) loss were significantly more likely at the end of follow-up in patients having a flare (P = .0001 and .001, respectively). In the high viremia group, a proportionate increase in virologic response was observed as the degree of flare increased. By multivariate analysis, high baseline HBV DNA, high pretreatment ALT, and both moderate and severe ALT flare were independently predictive of a virologic response with severe flare being the most powerful predictor for a sustained loss of serum HBV DNA (odds ratio, 5.3; P = .004). Severe flare was predictive of a virologic response in the high but not low viremia group. We conclude that a virologic response in patients with high-level viremia is dependent on the degree of ALT flare. Induction of a robust flare may enhance virologic response when high-level viremia is detected. [source] Question of ALT flare during switch to adefovir from lamivudine: A single center open-label, randomized, safety study (June 17, 2005 to February 5, 2009),JOURNAL OF MEDICAL VIROLOGY, Issue 9 2010Hie-Won L. Hann Abstract Earlier clinical studies have reported an ALT flare greater than 10 times the upper limit of normal in some patients with chronic hepatitis B when their lamivudine (LAM) treatment was switched to adefovir (ADV) therapy. The current study compared the safety of switching directly to ADV versus overlapping LAM and ADV for 3 months followed by ADV monotherapy. Patients with chronic hepatitis B receiving LAM therapy for ,6 months were eligible for the study regardless of the presence of LAM resistance, HBeAg status or serum ALT levels. Eighteen patients (13 males) were randomized to direct switch to ADV and 17 patients (10 males) to overlap. HBV-DNA, ALT, albumin, and total bilirubin were assayed at baseline, 3, 6, 9, and 12 months. Study drugs were discontinued at the end of 12 months with the follow up at 3 and 6 months. The decision to continue antiviral therapy was made at the discretion of the investigator. Baseline ALT levels were similar between the direct switch and overlap group: median ALT (U/L) was 44.0 (16,266) and 33.0 (19,367) for direct switch for overlap group, respectively (P,=,0.42). No ALT flare was noted at 3 months in either group: median ALT decreased from 44.0 to 34.5,U/L in the direct switch group, and from 33.0 to 23.0 in the overlap group. Furthermore, no patient in either group exhibited ALT flare throughout the 12 months. This study did not show an ALT flare during switch to ADV at 3 months or at any time later. J. Med. Virol. 82:1489,1493, 2010. © 2010 Wiley-Liss, Inc. [source] Virological, serological and biochemical outcomes through 3 years of entecavir treatment in nucleoside-naive Chinese chronic hepatitis B patientsJOURNAL OF VIRAL HEPATITIS, Issue 2010G. B. Yao Summary., Hepatitis B virus (HBV) infection has a high prevalence in China. Entecavir has shown superior efficacy over lamivudine in Chinese nucleoside-naive chronic hepatitis B (CHB) patients over 48 weeks, with continued clinical benefit to 96 weeks. The present study evaluates the long-term efficacy of entecavir in Chinese CHB patients who continued entecavir treatment for 144 weeks. Patients receiving either entecavir 0.5 mg/day (n = 258) or lamivudine 100 mg/day (n = 261) entered the initial 96-week randomized, double-blind, controlled efficacy study. Patients who did not achieve a consolidated response [HBV DNA <0.7 MEq/mL; alanine aminotransferase (ALT) <1.25 × upper limit of normal; and if hepatitis B e antigen (HBeAg) positive at baseline, loss of HBeAg for ,24 weeks] or who experienced viral breakthrough or relapse entered a 48-week entecavir rollover study. A total of 160 patients received continuous entecavir for 144 weeks; of these, 89% had undetectable serum HBV DNA, 86% showed ALT normalization, 20% reported HBeAg loss and 8% experienced HBeAg seroconversion. The cumulative rates of HBeAg loss and seroconversion were 36% and 27% at Week 144, respectively. The development of resistance was low, with three patients up to Week 96 and an additional two patients in Weeks 96,144 showing evidence of associated genotypic mutations. Entecavir was well tolerated. Adverse event rates were similar to those in lamivudine-treated patients, but patients receiving entecavir experienced fewer ALT flares. This study demonstrates that entecavir provides durable, long-term suppression of HBV DNA and ALT normalization in Chinese CHB patients, and is associated with low rates of emerging resistance. The results are consistent with the findings using entecavir globally and in Japan. [source] | ||||||||||