In an open-label clinical trial, treatment-naive patients with hepatitis B virus infection showed similar sustained virologic response rates to four different treatment regimens, according to study findings published in The Saudi Journal of Gastroenterology.
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“The purpose of this study was to compare antiviral efficacy of these four agents [lamivudine, entecavir, telbivudine and the combination of lamivudine and adefovir dipivoxil (CLA)] and to provide further recommendations for selection of oral agents in the treatment of [nucleotide]-naive [chronic hepatitis B] patients,” the researchers wrote.
Researchers enrolled 164 patients with HBV from The First Affiliated Hospital of Anhui Medical University in China and dosed them with either lamivudine (LAM; n=69), entecavir (ETV; n=25), telbivudine (LDT; n=33) or CLA (n=37) for 52 weeks. Alanine transaminase, HBV DNA and hepatitis B e antigen serum levels were measured at baseline, 12, 24 and 52 weeks to determine any differences between antiviral efficacy.
Of all the patients, 155 completed the study; most patients were male and were aged 17 to 70 years.
Virologic response rates increased during the duration of treatment in patients across all groups, according to the research. At 12 weeks, virologic response rates were 74% in the LAM group, 84% in the ETV group, 70% in the LDT group and 78% in the CLA group; at 24 weeks, virologic response rates were 80% for the LAM group, 96% for the ETV group, 82% for the LDT group and 89% in the CLA group; and at 52 weeks, virologic response rates were 83% in the LAM group, 96% in the ETV group, 91% in the LDT group and 89% in the CLA group.
After 12 weeks of therapy, HBeAg loss rates were 34% in the LAM group, 39% in the ETV group, 28% in the LDT group and 35% in the CLA group. At 52 weeks, HBeAg loss rates were 36% in the LAM group, 39% in the ETV group, 48% in the LDT group and 35% in the CLA group.
Using quantitative polymerase chain reaction assay, researchers were able to find that 131 patients had undetectable HBV DNA at 24 weeks of treatment. Of these patients, 94% maintained HBV DNA levels below the detection limit at 52 weeks, according to the research.
“All four treatments administered in this study showed no statistically significant differences when given to [nucleotide-naive] patients,” the researchers concluded.
Disclosure: The researchers report no relevant financial disclosures.