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Adefovir Dipivoxil

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Carol L Brosgart – 1st expert on this subject based on the ideXlab platform

  • extended treatment with lamivudine and Adefovir Dipivoxil in chronic hepatitis b patients with lamivudine resistance
    Hepatology International, 2011
    Co-Authors: Robert P Perrillo, H W L Hann, Carol L Brosgart, Eugene R Schiff, David Mutimer, Bernard Willems, Nancy Leung, Susan Dixon, Mary Woessner, Lynn D Condreay

    Abstract:

    Purpose
    We and others have reported that adding Adefovir Dipivoxil (Adefovir) to lamivudine results in virological and biochemical improvement in cases of lamivudine resistance. The current study assessed the efficacy and safety of combined therapy after 104 weeks of combined treatment and analyzed the frequency of persistent lamivudine resistant HBV.

  • long term therapy with Adefovir Dipivoxil for hbeag negative chronic hepatitis b for up to 5 years
    Gastroenterology, 2006
    Co-Authors: Stephanos J Hadziyannis, Nicolaos C Tassopoulos, Jenny E Heathcote, Tingtsung Chang, G Kitis, Mario Rizzetto, Patrick Marcellin, Zachary Goodman, Carol L Brosgart, Katyna Borroto Esoda

    Abstract:

    Background & Aims: Treatment with Adefovir Dipivoxil for 48 weeks resulted in clinical improvement in patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B that was lost when treatment was discontinued. We investigated the efficacy, safety, and resistance profile of Adefovir Dipivoxil treatment for up to 240 weeks. Methods: HBeAg-negative patients were treated double blind with placebo or Adefovir Dipivoxil 10 mg once daily for 48 weeks, followed by Adefovir Dipivoxil from week 49 to 96. At week 97, 125 patients enrolled in a 144-week, open-label phase. Patients received Adefovir Dipivoxil for up to 192 or 240 weeks. Results: Serum hepatitis B virus (HBV) DNA levels were less than 1000 copies per milliliter in 67% of patients, and alanine aminotransferase (ALT) levels normalized in 69% after 240 weeks. After 192 or 240 weeks of treatment, over 83% of patients had improvement in necroinflammation, and over 73% had improvement in fibrosis. Ishak fibrosis scores improved compared with baseline in 35%, 55%, and 71% of patients after 48, 192, and 240 weeks of Adefovir Dipivoxil, respectively. After 240 weeks, the cumulative probability of HBV polymerase mutations was 29%, but the cumulative probability of mutations with virologic resistance was 20% and of mutations, virologic resistance, and ALT elevations was 11%. Slight elevations in creatinine were confirmed in 4 (3%) patients. Conclusions: Treatment with Adefovir Dipivoxil for up to 240 weeks was well tolerated and produced significant, increasing improvement in hepatic fibrosis, durable suppression of HBV replication, normalization of liver enzymes, and delayed development of resistance.

  • safety and efficacy of Adefovir Dipivoxil in patients infected with lamivudine resistant hepatitis b and hiv 1
    Journal of Hepatology, 2006
    Co-Authors: Yves Benhamou, Vincent Thibault, Vincent Calvez, M H Fievet, Annegenevieve Marcelin, Graeme Currie, Chuy G Chang, Lu Biao, Shelly Xiong, Carol L Brosgart

    Abstract:

    BACKGROUND/AIMS: Adefovir Dipivoxil (10 mg once-daily) was added to antiretroviral therapy including lamivudine in 35 HIV/HBV co-infected patients. METHODS: Parameters evaluated included alanine aminotransferase (ALT), HBV DNA and serological markers, HIV-1 RNA, and CD4+ cell count. RESULTS: Twenty-nine patients (83%) completed 144 weeks. Serum HBV DNA declined from a baseline 9.76 log10 copies/mL (median) to 4.68, 5.24, and 5.90 log10 copies/mL at weeks 48, 96, and 144, respectively (P<0.0001 at all time points). Seven patients (25%) achieved HBV DNA<2.3 log10 copies/mL. No Adefovir-associated resistance mutations in HBV DNA polymerase or HIV-1 reverse transcriptase were detected. ALT declined from 81 IU/L (median) at baseline by -16.0, -44.5, and -46.0 IU/L at week 48, 96 and 144, respectively (P=<0.05, respectively), and normalized in 71% of patients (20 of 28) by week 144. Two patients developed antibodies against HB 'e' antigen by week 48. No serious adverse events related to Adefovir Dipivoxil occurred during the study, and HIV-1 RNA and CD4+ cell counts were stable. CONCLUSIONS: Treatment with Adefovir Dipivoxil for 144 weeks was well tolerated and resulted in significant and sustained reductions in HBV DNA and ALT in HIV/HBV co-infected patients. Efficacy increased with treatment duration, with no loss of viral suppression.

Stephanos J Hadziyannis – 2nd expert on this subject based on the ideXlab platform

  • long term therapy with Adefovir Dipivoxil for hbeag negative chronic hepatitis b for up to 5 years
    Gastroenterology, 2006
    Co-Authors: Stephanos J Hadziyannis, Nicolaos C Tassopoulos, Jenny E Heathcote, Tingtsung Chang, G Kitis, Mario Rizzetto, Patrick Marcellin, Zachary Goodman, Carol L Brosgart, Katyna Borroto Esoda

    Abstract:

    Background & Aims: Treatment with Adefovir Dipivoxil for 48 weeks resulted in clinical improvement in patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B that was lost when treatment was discontinued. We investigated the efficacy, safety, and resistance profile of Adefovir Dipivoxil treatment for up to 240 weeks. Methods: HBeAg-negative patients were treated double blind with placebo or Adefovir Dipivoxil 10 mg once daily for 48 weeks, followed by Adefovir Dipivoxil from week 49 to 96. At week 97, 125 patients enrolled in a 144-week, open-label phase. Patients received Adefovir Dipivoxil for up to 192 or 240 weeks. Results: Serum hepatitis B virus (HBV) DNA levels were less than 1000 copies per milliliter in 67% of patients, and alanine aminotransferase (ALT) levels normalized in 69% after 240 weeks. After 192 or 240 weeks of treatment, over 83% of patients had improvement in necroinflammation, and over 73% had improvement in fibrosis. Ishak fibrosis scores improved compared with baseline in 35%, 55%, and 71% of patients after 48, 192, and 240 weeks of Adefovir Dipivoxil, respectively. After 240 weeks, the cumulative probability of HBV polymerase mutations was 29%, but the cumulative probability of mutations with virologic resistance was 20% and of mutations, virologic resistance, and ALT elevations was 11%. Slight elevations in creatinine were confirmed in 4 (3%) patients. Conclusions: Treatment with Adefovir Dipivoxil for up to 240 weeks was well tolerated and produced significant, increasing improvement in hepatic fibrosis, durable suppression of HBV replication, normalization of liver enzymes, and delayed development of resistance.

  • long term therapy with Adefovir Dipivoxil for hbeag negative chronic hepatitis b
    The New England Journal of Medicine, 2005
    Co-Authors: Stephanos J Hadziyannis, Nicolaos C Tassopoulos, Jenny E Heathcote, Tingtsung Chang, G Kitis, Mario Rizzetto, Patrick Marcellin, Zachary Goodman, S Arterburn, S Xiong

    Abstract:

    Background Treatment with Adefovir Dipivoxil for 48 weeks resulted in histologic, virologic, and biochemical improvement in patients with hepatitis B e antigen (HBeAg)–negative chronic hepatitis B. We evaluated the effect of continued therapy as compared with cessation of therapy. Methods One hundred eighty-five HBeAg-negative patients with chronic hepatitis B were assigned to receive 10 mg of Adefovir Dipivoxil or placebo once daily for 48 weeks (ratio, 2:1). After week 48, patients receiving Adefovir Dipivoxil were again randomly assigned either to receive an additional 48 weeks of the drug or to switch to placebo. Patients originally assigned to placebo were switched to Adefovir Dipivoxil. Patients treated with Adefovir Dipivoxil during weeks 49 through 96 were subsequently offered continued therapy. The primary end points were changes in hepatitis B virus (HBV) DNA and alanine aminotransferase levels. Results Treatment with Adefovir Dipivoxil resulted in a median decrease in serum HBV DNA of 3.47 log …

  • Adefovir Dipivoxil in the treatment of chronic hepatitis B virus infection.
    Expert Review of Anti-infective Therapy, 2004
    Co-Authors: Stephanos J Hadziyannis, George V. Papatheodoridis

    Abstract:

    Adefovir Dipivoxil (Hepsera®, Gilead Sciences) is a prodrug of Adefovir, with potent antiviral activity against hepatitis B virus. Adefovir Dipivoxil therapy, 10 mg daily for 48 weeks, is effective in hepatitis B e antigen-positive and -negative chronic hepatitis B. In hepatitis B e antigen-negative chronic hepatitis B, Adefovir Dipivoxil was recently found to maintain its efficacy even after 3 years of therapy. Adefovir Dipivoxil is effective in patients with compensated or decompensated chronic viral B liver disease, and in pre- and post-transplant hepatitis B virus patients who develop resistance to lamivudine (Epivir®, GlaxoSmithKline). It is well-tolerated and safe even after the third year of long-term therapy, and is associated with low rates of viral resistance. All these characteristics make Adefovir Dipivoxil an important drug for the treatment of hepatitis B virus infection and an excellent candidate for long-term maintenance therapy in chronic viral B liver disease.

Patrick Marcellin – 3rd expert on this subject based on the ideXlab platform

  • sustained hepatitis b e antigen seroconversion in patients with chronic hepatitis b after Adefovir Dipivoxil treatment analysis of precore and basal core promoter mutants
    Clinical Infectious Diseases, 2008
    Co-Authors: Ichin Wu, Patrick Marcellin, Myron J Tong, Mitchell L Shiffman, Elsa Mondou, David Frederick, Andrea Snow Lampart, J Sorbel, Franck Rousseau, Tingtsung Chang

    Abstract:

    BACKGROUND: This study evaluated the persistence of hepatitis B e antigen (HBeAg) seroconversion (which is considered to be an important therapeutic end point) after Adefovir Dipivoxil treatment. METHODS: Forty-five patients who experienced confirmed HBeAg seroconversion and had a serum hepatitis B virus DNA level < 10(5) copies/mL while receiving 10 mg of Adefovir Dipivoxil in a prior study were enrolled in the present study. At the time of the last dose of Adefovir Dipivoxil (baseline), the median age of the patients was 35 years, 64% were male, 73% were Asian, 27% were white, the median alanine aminotransferase level was 25 IU/L, and the median serum hepatitis B virus DNA level was 3.0 log copies/mL. The median follow-up time was 150 weeks (range, 13-252 weeks). RESULTS: Forty-one patients maintained sustained seroconversion at the last 2 assessments, and 4 experienced seroreversion at weeks 12 (3 patients) and 16 (1 patient) of follow-up. Approximately 50% of patients had a hepatitis B virus DNA level < 1000 copies/mL at the last visit of the study period. Of 13 patients who were viremic and had available samples at the last visit, 11 had basal core promoter and/or precore mutations. Notably, 8 of these 11 patients had basal core promoter and/or precore mutations before Adefovir Dipivoxil therapy despite being HBeAg positive. The median duration of Adefovir Dipivoxil treatment was shorter before seroconversion (48 vs. 108 weeks; P = .03) and longer after seroconversion (41 vs. 22 weeks; P = .02) for patients who experienced sustained seroconversion, compared with the patients who experienced seroreversion. CONCLUSIONS: Prolonged Adefovir Dipivoxil therapy after HBeAg seroconversion appeared to increase the likelihood of sustained HBeAg seroconversion. Most patients who experienced HBeAg seroconversion and had viremia had precore and/or basal core promoter mutants, which usually existed before initiation of Adefovir Dipivoxil therapy.

  • long term therapy with Adefovir Dipivoxil for hbeag negative chronic hepatitis b for up to 5 years
    Gastroenterology, 2006
    Co-Authors: Stephanos J Hadziyannis, Nicolaos C Tassopoulos, Jenny E Heathcote, Tingtsung Chang, G Kitis, Mario Rizzetto, Patrick Marcellin, Zachary Goodman, Carol L Brosgart, Katyna Borroto Esoda

    Abstract:

    Background & Aims: Treatment with Adefovir Dipivoxil for 48 weeks resulted in clinical improvement in patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B that was lost when treatment was discontinued. We investigated the efficacy, safety, and resistance profile of Adefovir Dipivoxil treatment for up to 240 weeks. Methods: HBeAg-negative patients were treated double blind with placebo or Adefovir Dipivoxil 10 mg once daily for 48 weeks, followed by Adefovir Dipivoxil from week 49 to 96. At week 97, 125 patients enrolled in a 144-week, open-label phase. Patients received Adefovir Dipivoxil for up to 192 or 240 weeks. Results: Serum hepatitis B virus (HBV) DNA levels were less than 1000 copies per milliliter in 67% of patients, and alanine aminotransferase (ALT) levels normalized in 69% after 240 weeks. After 192 or 240 weeks of treatment, over 83% of patients had improvement in necroinflammation, and over 73% had improvement in fibrosis. Ishak fibrosis scores improved compared with baseline in 35%, 55%, and 71% of patients after 48, 192, and 240 weeks of Adefovir Dipivoxil, respectively. After 240 weeks, the cumulative probability of HBV polymerase mutations was 29%, but the cumulative probability of mutations with virologic resistance was 20% and of mutations, virologic resistance, and ALT elevations was 11%. Slight elevations in creatinine were confirmed in 4 (3%) patients. Conclusions: Treatment with Adefovir Dipivoxil for up to 240 weeks was well tolerated and produced significant, increasing improvement in hepatic fibrosis, durable suppression of HBV replication, normalization of liver enzymes, and delayed development of resistance.

  • long term therapy with Adefovir Dipivoxil for hbeag negative chronic hepatitis b
    The New England Journal of Medicine, 2005
    Co-Authors: Stephanos J Hadziyannis, Nicolaos C Tassopoulos, Jenny E Heathcote, Tingtsung Chang, G Kitis, Mario Rizzetto, Patrick Marcellin, Zachary Goodman, S Arterburn, S Xiong

    Abstract:

    Background Treatment with Adefovir Dipivoxil for 48 weeks resulted in histologic, virologic, and biochemical improvement in patients with hepatitis B e antigen (HBeAg)–negative chronic hepatitis B. We evaluated the effect of continued therapy as compared with cessation of therapy. Methods One hundred eighty-five HBeAg-negative patients with chronic hepatitis B were assigned to receive 10 mg of Adefovir Dipivoxil or placebo once daily for 48 weeks (ratio, 2:1). After week 48, patients receiving Adefovir Dipivoxil were again randomly assigned either to receive an additional 48 weeks of the drug or to switch to placebo. Patients originally assigned to placebo were switched to Adefovir Dipivoxil. Patients treated with Adefovir Dipivoxil during weeks 49 through 96 were subsequently offered continued therapy. The primary end points were changes in hepatitis B virus (HBV) DNA and alanine aminotransferase levels. Results Treatment with Adefovir Dipivoxil resulted in a median decrease in serum HBV DNA of 3.47 log …