Patients infected with chronic hepatitis B virus infection showed good resistance profiles after treatment with clevudine and adefovir, compared with patients treated with clevudine monotherapy, according to results from a clinical trial.
Researchers conducted a randomized, open-label clinical trial with 57 chronic hepatitis B virus (HBV) patients in South Korea. Patients were randomly assigned 20 mg clevudine (n=17), 30 mg clevudine (n=18) or a combination of 20 mg clevudine and adefovir (n=22) for 96 weeks. All patients were treatment naive and had been positive for hepatitis B surface antigen for at least 6 months before treatment. Twenty-four patients from the 30-mg clevudine group, 23 from the 20-mg group and 20 from the combination group completed treatment at 24 weeks and underwent viral kinetics analysis before dropouts.
Patients in the combination group did not show any resistance, whereas 20% of patients treated with either dosage of clevudine experienced resistance during 24 months. Of those treated with the combination, 95% had HBV DNA levels less than 300 copies/mL at week 96, compared with 71% and 67% in the 20-mg and 30-mg clevudine groups, respectively (P=.0376). Viral breakthroughs were achieved in 17% of 20-mg clevudine patients, 28% in the 30-mg group and 0% in the combination group (P=.0149). Viral kinetics analysis revealed no statistical differences.