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

Guenther Schmutz, Mark Nelson, Thomas Lutz, Julie Sheldon, Raffaele Bruno, Florian Von Boemmel, Christian Hoffmann, Juergen Rockstroh, Albrecht Stoehr, Eva Wolf, Vincent Soriano, Florian Berger, Thomas Berg, Amina Carlebach, Carolynne Schwarze-Zander, Dirk Schürmann, Hans Jaeger, Stefan Mauss

Research output: Contribution to journalArticle

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 × 10 copies/ml compared to 1.37 × 10copies/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.

Original languageEnglish
Pages (from-to)1951-1954
Number of pages4
JournalAIDS (London, England)
Volume20
Issue number15
DOIs
Publication statusPublished - Oct 2006

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Tenofovir
Lamivudine
Hepatitis B
Coinfection
HIV
Hepatitis B virus
Chronic Hepatitis B
Therapeutics
Antigens
DNA

Keywords

  • Combination therapy
  • HBV/HIV-coinfection
  • Lamivudine
  • Monotherapy
  • Tenofovir

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

Cite this

Combination of tenofovir and lamivudine versus tenofovir after lamivudine failure for therapy of hepatitis B in HIV-coinfection. / Schmutz, Guenther; Nelson, Mark; Lutz, Thomas; Sheldon, Julie; Bruno, Raffaele; Von Boemmel, Florian; Hoffmann, Christian; Rockstroh, Juergen; Stoehr, Albrecht; Wolf, Eva; Soriano, Vincent; Berger, Florian; Berg, Thomas; Carlebach, Amina; Schwarze-Zander, Carolynne; Schürmann, Dirk; Jaeger, Hans; Mauss, Stefan.

In: AIDS (London, England), Vol. 20, No. 15, 10.2006, p. 1951-1954.

Research output: Contribution to journalArticle

Schmutz, G, Nelson, M, Lutz, T, Sheldon, J, Bruno, R, Von Boemmel, F, Hoffmann, C, Rockstroh, J, Stoehr, A, Wolf, E, Soriano, V, Berger, F, Berg, T, Carlebach, A, Schwarze-Zander, C, Schürmann, D, Jaeger, H & Mauss, S 2006, 'Combination of tenofovir and lamivudine versus tenofovir after lamivudine failure for therapy of hepatitis B in HIV-coinfection', AIDS (London, England), vol. 20, no. 15, pp. 1951-1954. https://doi.org/10.1097/01.aids.0000247116.89455.5d
Schmutz, Guenther ; Nelson, Mark ; Lutz, Thomas ; Sheldon, Julie ; Bruno, Raffaele ; Von Boemmel, Florian ; Hoffmann, Christian ; Rockstroh, Juergen ; Stoehr, Albrecht ; Wolf, Eva ; Soriano, Vincent ; Berger, Florian ; Berg, Thomas ; Carlebach, Amina ; Schwarze-Zander, Carolynne ; Schürmann, Dirk ; Jaeger, Hans ; Mauss, Stefan. / Combination of tenofovir and lamivudine versus tenofovir after lamivudine failure for therapy of hepatitis B in HIV-coinfection. In: AIDS (London, England). 2006 ; Vol. 20, No. 15. pp. 1951-1954.
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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 × 10 copies/ml compared to 1.37 × 10copies/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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T1 - Combination of tenofovir and lamivudine versus tenofovir after lamivudine failure for therapy of hepatitis B in HIV-coinfection

AU - Schmutz, Guenther

AU - Nelson, Mark

AU - Lutz, Thomas

AU - Sheldon, Julie

AU - Bruno, Raffaele

AU - Von Boemmel, Florian

AU - Hoffmann, Christian

AU - Rockstroh, Juergen

AU - Stoehr, Albrecht

AU - Wolf, Eva

AU - Soriano, Vincent

AU - Berger, Florian

AU - Berg, Thomas

AU - Carlebach, Amina

AU - Schwarze-Zander, Carolynne

AU - Schürmann, Dirk

AU - Jaeger, Hans

AU - Mauss, Stefan

PY - 2006/10

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N2 - 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 × 10 copies/ml compared to 1.37 × 10copies/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.

AB - 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 × 10 copies/ml compared to 1.37 × 10copies/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.

KW - Combination therapy

KW - HBV/HIV-coinfection

KW - Lamivudine

KW - Monotherapy

KW - Tenofovir

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