Treatment Outcomes of Clevudine versus Lamivudine at Week 48 in Naïve Patients with HBeAg Positive Chronic Hepatitis B
نویسندگان
چکیده
The authors assessed the efficacy and antiviral resistance of 48-week clevudine therapy versus lamivudine in treatment of naïve patients with HBeAg positive chronic hepatitis B. In this retrospective study, a total of 116 HBeAg positive patients, who received 30 mg of clevudine once daily (n=53) or 100 mg of lamivudine once daily (n=63) for 48 weeks, were included. At week 48, clevudine therapy produced a significantly greater mean reductions in serum HBV DNA levels from baseline than lamivudine therapy (-5.2 vs. -4.2 log(10)IU/mL; P=0.005). Furthermore, a significantly higher proportion of patients on clevudine achieved negative serum HBV DNA by PCR (<13 IU/mL) at week 48 (60.4% vs. 38.1%; P=0.025). The incidence of virologic breakthrough in the clevudine group was significantly lower than in the lamivudine group (9.4% vs. 25.4%; P=0.031). However, rates of alanine aminotransferase normalization and HBeAg loss or seroconversion were similar in the two groups (83.0% vs. 81.0%, 11.3% vs. 11.1%; P=0.813, 1.000, respectively). In conclusion, clevudine is more potent for viral suppression and lower for antiviral resistance at week 48 than lamivudine in treatment of naïve patients with HBeAg positive chronic hepatitis B.
منابع مشابه
Forty-eight weeks treatment with clevudine 30 mg qd versus lamivudine 100 mg qd for chronic hepatitis B infection: a double-blind randomized study
BACKGROUND/AIMS Clevudine is a pyrimidine analogue with potent activity against hepatitis B virus (HBV) replication in vitro. In a previous pivotal phase III clinical study, 24 weeks treatment with clevudine 30 mg has been shown to profoundly suppress HBV replication and normalize serum alanine aminotransferase level. METHODS In this study, we compare the efficacy and safety of clevudine (30 ...
متن کاملClevudine demonstrates potent antiviral activity in naïve chronic hepatitis B patients.
OBJECTIVES Clevudine has demonstrated antiviral potency in the treatment of naïve chronic hepatitis B patients in pivotal studies. The objectives of this study were to evaluate the safety and efficacy of a 1-year treatment with clevudine in chronic hepatitis B patients. METHODS This is a post-marketing surveillance using case report forms which were submitted to the health authorities. RESU...
متن کاملVirologic, serologic, and biochemical outcomes through 2 years of treatment with entecavir and lamivudine in nucleoside-naïve Chinese patients with chronic hepatitis B: a randomized, multicenter study
PURPOSE Entecavir demonstrated superior virologic and biochemical benefits over lamivudine at 48 weeks in nucleoside-naïve Chinese patients with chronic hepatitis B (CHB). We evaluated the effect of continued entecavir and lamivudine treatment in patients who continued treatment in year 2 and the off-treatment durability of patients who achieved a protocol-defined consolidated response at week ...
متن کاملLong-Term Treatment Efficacy and Safety of Clevudine Therapy in Naïve Patients with Chronic Hepatitis B
BACKGROUND/AIMS Clevudine (CLV) has potent antiviral activity against chronic hepatitis B (CHB) virus infection. The long-term efficacy and safety of CLV therapy in naïve patients with CHB were investigated. METHODS In this retrospective study, 152 naïve Korean patients with CHB who received 30 mg of CLV once daily for at least 12 months were investigated. RESULTS The cumulative rates at mo...
متن کاملThe search for cost-effective treatment of chronic hepatitis B.
Treatment of chronic hepatitis B remains challenging due to medication-resistant viral mutations, unanswered questions for initiation and duration of treatment, and risk for chronic liver complications. More than 400 million people worldwide are chronically infected with hepatitis B virus (HBV).1 Of those, an estimated 1 million die annually of HBV-related liver diseases.1 In the past decade, H...
متن کامل