Safety and efficacy of adefovir dipivoxil in patients co-infected with HIV-1 and lamivudine-resistant hepatitis B virus: an open-label pilot study

[Guest guest]

Lancet 2001 Sep 1;358(9283):718-23

Safety and efficacy of adefovir dipivoxil in patients co-infected with HIV-1

and lamivudine-resistant hepatitis B virus: an open-label pilot study.

Benhamou Y, Bochet M, Thibault V, Calvez V, Fievet MH, Vig P, Gibbs CS,

Brosgart C, Fry J, Namini H, Katlama C, Poynard T

Service d'Hepato-Gastroenterologie, Groupe Hospitalier Pitie-Salpetriere,

Paris, France

[Medline record in process]

Background Lamivudine-resistant hepatitis B virus (HBV) is found in about

15-32% of infected patients with or without co-infection with HIV-1 after 1

year of lamivudine therapy. Adefovir dipivoxil is active in vivo and in

vitro against wild-type and lamivudine-resistant HBV. We assessed the safety

and efficacy of a once daily dose of adefovir dipivoxil in an open-label

trial for the treatment of lamivudine-resistant HBV infection in

HIV-1-infected patients.Methods 35 HIV-1/HBV co-infected patients receiving

lamivudine therapy (150 mg twice daily) as part of their current HIV-1

antiretroviral regimen were enrolled. Patients received a 10 mg once-daily

dose of adefovir dipivoxil for48 weeks while maintaining their existing

anti-HIV-1 therapy, including lamivudine. Patients were assessed every 4

weeks for safety and efficacy.Findings Four patients withdrew from the study

(two because of adverse events), leaving 31 patients who received adefovir

dipivoxil for a median of 48 weeks (range 44-48). Mean decreases in serum

HBV DNA concentrations from baseline (log 8.64 copies/mL [sE log 0.08]) were

2log 3.40 copies/mL [log 0.12] at week 24 (n=31) and 2log 4.01 copies/mL

[log 0.17] at week 48 (n=29; p<0.0001). Two patients underwent hepatitis B e

antigen seroconversion-one at week 32 and one at week 36. Adefovir dipivoxil

was generally well tolerated, but was associated with a transient increase

in serum alanine aminotransferase concentrations in 15 patients. We found no

significant changes in either HIV-1 RNA or CD4 cell count.Interpretation

These results indicate that 48 weeks of 10 mg daily adefovir dipivoxil is

well tolerated and active against lamivudine-resistant HBV in HIV-1/HBV

co-infected patients.

PMID: 11551579, UI: 21436053

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[Guest guest]

Lancet 2001 Sep 1;358(9283):718-23

Safety and efficacy of adefovir dipivoxil in patients co-infected with HIV-1

and lamivudine-resistant hepatitis B virus: an open-label pilot study.

Benhamou Y, Bochet M, Thibault V, Calvez V, Fievet MH, Vig P, Gibbs CS,

Brosgart C, Fry J, Namini H, Katlama C, Poynard T

Service d'Hepato-Gastroenterologie, Groupe Hospitalier Pitie-Salpetriere,

Paris, France

[Medline record in process]

Background Lamivudine-resistant hepatitis B virus (HBV) is found in about

15-32% of infected patients with or without co-infection with HIV-1 after 1

year of lamivudine therapy. Adefovir dipivoxil is active in vivo and in

vitro against wild-type and lamivudine-resistant HBV. We assessed the safety

and efficacy of a once daily dose of adefovir dipivoxil in an open-label

trial for the treatment of lamivudine-resistant HBV infection in

HIV-1-infected patients.Methods 35 HIV-1/HBV co-infected patients receiving

lamivudine therapy (150 mg twice daily) as part of their current HIV-1

antiretroviral regimen were enrolled. Patients received a 10 mg once-daily

dose of adefovir dipivoxil for48 weeks while maintaining their existing

anti-HIV-1 therapy, including lamivudine. Patients were assessed every 4

weeks for safety and efficacy.Findings Four patients withdrew from the study

(two because of adverse events), leaving 31 patients who received adefovir

dipivoxil for a median of 48 weeks (range 44-48). Mean decreases in serum

HBV DNA concentrations from baseline (log 8.64 copies/mL [sE log 0.08]) were

2log 3.40 copies/mL [log 0.12] at week 24 (n=31) and 2log 4.01 copies/mL

[log 0.17] at week 48 (n=29; p<0.0001). Two patients underwent hepatitis B e

antigen seroconversion-one at week 32 and one at week 36. Adefovir dipivoxil

was generally well tolerated, but was associated with a transient increase

in serum alanine aminotransferase concentrations in 15 patients. We found no

significant changes in either HIV-1 RNA or CD4 cell count.Interpretation

These results indicate that 48 weeks of 10 mg daily adefovir dipivoxil is

well tolerated and active against lamivudine-resistant HBV in HIV-1/HBV

co-infected patients.

PMID: 11551579, UI: 21436053

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