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Tenofovir + 3TC or FTC Efficacy in HBV/HIV Coinfection: 85% <1000 IU/ml
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Reported by Jules Levin
EASL, April 2007, Barcelona, Spain
GV Mathews, e Seaberg, GJ dore, SR Lewin, S Bowden, J Sassadeuz, P Marks, J Hoy, S Locarnini, CL Thio. National centre in HIV Epidemiology and Clinical research, Sydney; VIDRL, Melbourne; VIDS, Melbourne; The Alfred Hospital, Melbourne
Background: Liver-related morbidity and mortality are increased in HIV-HBV coinfected individuals compared to those with HBV alone. The optimal antiviral therapy for this population is ill-defined.
Methods: An international collaborative cohort of 150 HIV/HBV coinfected individuals from the MACS cohort, USA (M) and two HIV units in Australia (A) was established to examine this issue. All patients were HIV-1/HBsAg positive prior to HAART and had 6 monthly follow-up for 3 years including HBV viral load testing (Artus, Light Cycler).
Results:
Baseline data were available for 120 patients (M=57, A=63). Demographic and clinical characteristics were similar between countries except ethnicity (M=47% African-American). The mean age was 47 years, 98% were male, 88% were MSM, 13% were IDU, and 69% were Caucasian.
The mean duration of HIV infection was 12 years, with a mean nadir CD4 cell count of 179 cells/mm3. At baseline, the mean CD4 count was 442 cells/mm3, 84% were on HAART (mean duration 6.5 years), and 31% had a prior AIDS diagnosis. In terms of HBV status, 47% were HBeAg positive, 49% had undetectable HBV DNA (< 20 IU/mL), and 16% had HBV DNA > 6 log IU/mL.
Baseline treatment by HBV-activr ART regimens was:
-- 46% on combination therapy (tenofovir [TDF] + lamivudine [LAM, 3TC] or emtricitabine [FTC] Group 1),
-- 28% on LAM (3TC) or FTC monotherapy Group 2,
-- 9% on TDF monotherapy Group 3, and
-- 16% on no HBV-active therapy Group 4.
HBV characteristics demonstrated an elevated mean baseline ALT (50 Iu/L), 47% were HbeAg positive, and HBV DNA <20 Iu/ml in 49%, 21-3 log IUs/ml in 22%, 3-6 log IUs/ml in 14%, and >6 log IUs/ml in 16%.
RESULTS
HBV DNA suppression was associated with HAART use (P = 0.02).
HAART that included the combination of tenofovir plus lamivudine or emtricitabine was associated with the lowest HBV DNA levels (P = 0.002).
The proportions of patients achieving HBV DNA levels < 1000 IU/mL were as follows:
--85% of those receiving tenofovir plus lamivudine (3TC) or emtricitabine (FTC)
--67% of those receiving lamivudine or emtricitabine as monotherapy
--60% of those receiving tenofovir monotherapy
--44% of those receiving no anti-HBV drugs
Conclusion
Data from this large cohort of HIV-HBV coinfected persons demonstrate that the majority (71%) have HBV DNA < 1000 IU/mL. Preliminary data suggest that combination [therapy] with tenofovir plus lamivudine or emtricitabine may be most effective at suppressing HBV replication. Further exploration of this association and surveillance for hepatotoxicity, for maintenance of viral suppression, and for development of drug-resistant HBV continues.
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