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Viread non-inferior to Baraclude in patients with chronic HBV
Viread showed non-inferiority to Baraclude in safety and treatment efficacy of lowering serum HBV-DNA at week 24 in nucleos(t)ide-analogues-naive patients with chronic hepatitis B, according to results of a recently published study.
“The major goal of [chronic hepatitis B (CHB)] treatment in the guidelines is to achieve undetectable serum HBV-DNA level, and serum HBV-DNA has been the only marker for monitoring HBV treatment until the recent advent of serum hepatitis B surface antigen (HBsAg) quantification methods,” the researchers wrote. “As [nucleos(t)ide-analogues] inhibit reverse transcription but not translation, suppression of HBV-DNA does not parallel HBsAg reduction. However, continuous [nucleos(t)ide-analogues] treatment may reduce HBsAg level gradually, and as it reflects the amount of covalently closed circular DNA (cccDNA), the treatment may reduce the risk of HCC development.”
Between November 2011 and June 2012, researchers enrolled 165 patients into the randomized, parallel-arm study, with 110 patients placed in the Viread (tenofovir disoproxil fumarate, Gilead; TDF) group and 55 patients placed in the Baraclude (entecavir hydrate, Bristol-Myers Squibb) group. Biochemically evaluable patients available at week 24 included 83 patients in the TDF group and 41 in the entecavir group.
At week 24, the mean change from baseline in HBV-DNA was –4.63 log10 copies/mL in the TDF group and –4.5 log10 copies/mL in the entecavir group. The upper limit of the 95% CI for the difference between the two groups was –0.28 to 0.2 log10 copies/mL. Alanine aminotransferase normalization occurred in 70% of the remaining patients in the TDF group at week 24, 72% at week 48 and 89% at week 96. ALT normalization occurred in 85% of the remaining patients in the entecavir group at week 24 and week 48.
The mean change from baseline HBsAg level in the entecavir group was –0.027 log10 IU/mL at week 24 and –0.051 log10 IU/mL at week 48.
The mean change from baseline HBsAg level in the TDF group was –0.147 log10 IU/mL at week 24, –0.208 log10 IU/mL at week 48 and –0.271 log10 IU/mL at week 96. HBsAg reduction was significantly greater in the TDF group (P < .05). Additionally, in the TDF group, HBsAg reduction was greater in HBV-positive patients (–0.365 log10 IU/mL) compared with HBV-negative patients (0.07 log10 IU/mL) at week 48. HBsAg reductions were greater in patients with ALT of 80 IU/L or greater (–4.10 log10 IU/mL) compared with patients with ALT of less than 80 IU/L (–0.105 log10 IU/mL).
In patients who were HBeAg-positive and HBeAg-negative at baseline, HBeAg/Ab seroconversions were observed in four out of 43 patients in the TDF group and two out of 27 patients in the entecavir group.
Regarding safety, there were 22 patients out of 109 in the TDF group and 10 patients out of 55 in the entecavir group who experienced an adverse event at week 48. Only one serious drug-related adverse event was recorded in a patient who developed arrhythmia.
“[Nucleos(t)ide-analogues] treatment reduces the disease progressions, but the treatment cannot sterilize persisting cccDNA in hepatocytes and cure this life-threatening infection,” the researchers wrote. “Thus, CHB treatment is ‘life-long,’ and chronic toxicity of [nucleos(t)ide-analogues] and acquisition of drug resistance continue to hamper successful treatment. Although incurable, HBeAg/Ab and HBsAg/Ab seroconversion may allow [nucleos(t)ide-analogues] treatment to be interrupted (functional cure), and prevalence of HBsAg loss and HBsAg/Ab seroconversion is reported as 10% and 8%, respectively, after 5 years of TDF treatment.” – by Talitha Bennett
Disclosure: The researchers report no relevant financial disclosures.