Combination of tenofovir and lamivudine versus tenofovir after lamivudine

liver411

Combination of tenofovir and lamivudine versus tenofovir after lamivudine
failure for therapy of hepatitis B in HIV-coinfection.

CLINICAL SCIENCE

AIDS. 20(15):1951-1954, October 3, 2006.

Schmutz, Guenther a; Nelson, Mark b; Lutz, Thomas c; Sheldon, Julie d;
Bruno, Raffaele e; von Boemmel, Florian f; Hoffmann, Christian g; Rockstroh,
Juergen h; Stoehr, Albrecht g; Wolf, Eva i; Soriano, Vincent d; Berger,
Florian a; Berg, Thomas f; Carlebach, Amina c; Schwarze-Zander, Carolynne h;
Schurmann, Dirk f; Jaeger, Hans i; Mauss, Stefan a

Abstract:
Objective: At present sequential monotherapy for chronic hepatitis B with
hepatitis B virus (HBV)-polymerase inhibitors is clinical practice. It is
unknown to date whether combination therapy with lamivudine plus tenofovir
could be superior to sequential therapy with tenofovir after the occurrence
of lamivudine resistance.

Methods: We conducted a multicenter, 1: 2 matched pair analysis comparing
patients with HBV/HIV-coinfection starting an antiretroviral regimen
including tenofovir plus lamivudine with patients who had highly
replicative, lamivudine resistant HBe-antigen positive chronic hepatitis B
and started with tenofovir as the only active HBV polymerase inhibitor
subsequent to lamivudine.

Results: At baseline patients on tenofovir plus lamivudine (n = 25) had a
median HBV DNA of 5.9 x 107 copies/ml compared to 1.37 x 108copies/ml in the
tenofovir arm (n = 50; P = 0.32). A sustained undetectable HBV DNA < 1000
copies/ml was achieved in 19/25 (76%) patients on tenofovir plus lamivudine
and in 42/50 (84%) on tenofovir (P = 0.53). A loss of HBe-antigen was
observed in 9/25 (36%) patients on tenofovir plus lamivudine and in 12/50
(24%) patients on tenofovir (P = 0.29). HBs-antigen loss was found in 1/25
(4%) and 3/50 (6%) patients.

Conclusions: In this cohort of HBV/HIV-coinfected individuals, full HBV DNA
suppression was achieved in the majority of patients independent of
treatment allocation. Loss of HBe- and HBs-antigen was not different between
the two study arms. Over a median treatment period of 116 weeks tenofovir
was as effective as tenofovir plus lamivudine. Longer treatment periods may
be needed to evaluate potential benefits of first-line combination therapy
for chronic hepatitis B.

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