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  HIV and Hepatitis.com Coverage of the
 44th Annual Meeting of the European Association for
 the Study of the Liver (EASL 2009)
  April 22 - 26, 2009, Copenhagen, Denmark
 The material posted on HIV and Hepatitis.com about EASL 2009 is not approved by nor is it a part of EASL 2009.

Safety and Efficacy of 96 Weeks of Tenofovir (Viread) in Chronic Hepatitis B Patients Previously Treated with Lamivudine (Epivir-HBV)

The U.S. Food and Drug Administration (FDA) approved tenofovir (Viread) for the treatment of chronic hepatitis B virus (HBV) infection in August 2008; the drug has been approved for HIV treatment since 2001.

Tenofovir has previously demonstrated activity against HBV that has developed resistance to lamivudine (Epivir-HBV). In a presentation at the 44th Annual Meeting of the European Association for the Study of the Liver (EASL 2009) last week in Copenhagen, investigators presented data on tenofovir response at 96 weeks among a subset of participants from studies 102 and 103 who had previously been treated for more than 12 weeks with lamivudine or the related drug emtricitabine (Emtriva).

In these pivotal double-blind Phase 3 studies, participants were randomized 2:1 to receive 300 mg once-daily tenofovir or 10 mg once-daily adefovir (Hepsera). After 48 weeks, patients with a week 48 biopsy continued on open-label tenofovir for up to 7 additional years.

Study 102 included hepatitis B "e" antigen (HBeAg) negative patients, while Study 103 included HBeAg positive participants. Across both studies, a total of 426 patients were initially randomized to the tenofovir arm (51 lamivudine-experienced and 375 lamivudine-naive).

HBV suppression was defined as HBV DNA < 400 copies/mL or 69 IU/mL.

Results

49 lamivudine-experienced and 350 lamivudine-naive patients completed 96 weeks of tenofovir treatment; a majority of lamivudine-experienced patients (n = 41) were HBeAg negative.

In an intent-to-treat analysis, a similar proportion of patients achieved HBV suppression at week 96 in the lamivudine-experienced and lamivudine-naive subgroups (92% vs 84%).

Response rates were also similar in an on-treatment analysis (98% vs 95%, respectively).

91% of lamivudine-experienced and 77% of lamivudine-naive patients had normal ALT at week 96.

No lamivudine-experienced patients achieved hepatitis B surface antigen (HBsAg) loss.

No HBV pol/RT amino acid substitutions associated with tenofovir resistance were detected through 96 weeks of tenofovir monotherapy in lamivudine-experienced patients.

During year 2, no lamivudine-experienced patients experienced serious adverse events or discontinued therapy due to an adverse event.

5 patients experienced new grade 3-4 laboratory abnormalities; elevated serum lipase (4%) was the only abnormality occurring in more than 1 patient (n = 2).

While receiving open-label tenofovir for 96 weeks, no lamivudine-experienced patients had a confirmed decrease in creatinine clearance < 50 mL/min, an increase in creatinine of > 0.5 mg/dL, or a graded serum creatinine abnormality.

Based on these findings, the investigators concluded, "The safety, efficacy, and resistance analysis results for 96 weeks of tenofovir treatment were similar in lamivudine-experienced and lamivudine-naive chronic HBV patients. Longer follow up is ongoing."

Medizinische Hochschule Hannover, Hannover, Germany; University of Miami School of Medicine, Miami, FL; University of Thessaly Medical School, Larissa, Greece, Charité Universitätsmedizin, Berlin, Germany; Hopital de Hotel Dieu, Lyon, France; Alfred Hospital, Melbourne, Victoria, Australia; Hospital La Fe, Valencia, Spain; University of Torino, Torino, Italy; University of Paris, Clichy, France; University of Toronto, Toronto, Ontario, Canada; Gilead Sciences, Inc., Durham, NC.

4/28/09

Reference
M Manns, L Jeffers, G Dalekos, and others. Safety and efficacy of 96 weeks of tenofovir disoproxil fumarate therapy in lamivudine-experienced patients. 44th Annual Meeting of the European Association for the Study of the Liver (EASL 2009). Copenhagen, Denmark. April 22-26, 2009.


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