AASLD 2013: Tenofovir for Hepatitis B Remains Safe and Effective Over 7 Years

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Chronic hepatitis B patients treated with tenofovir (Viread) for 7 years continued to main viral suppression and liver enzyme normalization, while serological response rates continued to increase, according to a poster presented at the 64th AASLD Liver Meeting last month in Washington, DC. Long-term kidney and bone-related side effects remained uncommon.

Nucleoside/nucleotide antivirals such as tenofovir disoproxil fumarate or entecavir (Baraclude) effectively suppress hepatitis B virus (HBV) replication, but they usually do not eradicate the virus and may need to be taken long term.

Patrick Marcellin from the University of Paris and colleagues presented the latest findings from Study 102 and Study 103, a pair of Phase 3 trials that evaluated tenofovir in hepatitis B "e" antigen (HBeAg) negative and positive patients, respectively.

In both trials, participants were randomly assigned to receive 300 mg once-daily tenofovir or 10 mg adefovir (Hepsera) for 1 year, after which they could elect to continue on open-label tenofovir for up to 8 years. People with continued detectable virus despite tenofovir had the option to add emtricitabine (Emtriva).

Together, the studies enrolled more than 600 treatment-naive participants; 437 (68%) were still being followed at year 7. About three-quarters were men, about 60% were white, 30% were Asian, and the mean age was approximately 40 years. Just under 25% had liver cirrhosis.

Results

o   HBeAg negative: 77% at year 7 vs 81% at year 6;

o   HBeAg positive: 60% at year 7 vs 63% at year 6.

o   HBeAg negative: 65% at year 7 vs 70% at year 6;

o   HBeAg positive: 47% at year 7 vs 51% at year 6.

"Virologic, biochemical, and serologic responses [to tenofovir] were well maintained through 7 years," the researchers concluded. "No resistance to [tenofovir] was detected through 7 years."

12/4/13

Reference

P Marcellin, EJ Gane, N Tsai, et al. Seven Years of Treatment with Tenofovir DF for Chronic Hepatitis B Virus Infection is Safe and Well Tolerated and Associated with Sustained Virological, Biochemical, and Serological Responses with no Detectable Resistance. 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2013). Washington, DC, November 1-5, 2013. Abstract 926.