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  1. Article: [No title information]

    Pessoa, Mário G / Mendizábal, Manuel

    Clinical liver disease

    2019  Volume 13, Issue Suppl 1, Page(s) S1

    Title translation Prólogo: Una colaboración entre CLD y la Asociación Latinoamericana para el Estudio del Hígado (ALEH).
    Language Spanish
    Publishing date 2019-05-29
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2657644-2
    ISSN 2046-2484
    ISSN 2046-2484
    DOI 10.1002/cld.835
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  2. Article ; Online: Biomarkers in Hepatocellular Carcinoma: Diagnosis, Prognosis and Treatment Response Assessment.

    Piñero, Federico / Dirchwolf, Melisa / Pessôa, Mário G

    Cells

    2020  Volume 9, Issue 6

    Abstract: Hepatocellular carcinoma (HCC) is one of the main cancer-related causes of death worldwide. Thus, there is a constant search for improvement in screening, diagnosis, and treatment strategies to improve the prognosis of this malignancy. The identification ...

    Abstract Hepatocellular carcinoma (HCC) is one of the main cancer-related causes of death worldwide. Thus, there is a constant search for improvement in screening, diagnosis, and treatment strategies to improve the prognosis of this malignancy. The identification of useful biomarkers for surveillance and early HCC diagnosis is still deficient, with available serum biomarkers showing low sensitivity and heterogeneous specificity despite different cut-off points, even when assessed longitudinally, or with a combination of serum biomarkers. In contrast, HCC biomarkers used for prognostic (when associated with clinical outcomes) or predictive purposes (when associated with treatment response) may have an increased clinical role in the near future. Furthermore, some serum biomarkers are already implicated as a treatment selection tool, whether to provide access to certain therapies or to assess clinical benefit after treatment. In the present review we will discuss the clinical utility and foreseen future of HCC biomarkers implicated in surveillance, diagnosis, prognosis, and post-treatment assessment.
    MeSH term(s) Animals ; Biomarkers, Tumor/metabolism ; Carcinoma, Hepatocellular/diagnosis ; Carcinoma, Hepatocellular/metabolism ; Carcinoma, Hepatocellular/pathology ; Carcinoma, Hepatocellular/therapy ; Genomics ; Humans ; Liver Neoplasms/diagnosis ; Liver Neoplasms/metabolism ; Liver Neoplasms/pathology ; Liver Neoplasms/therapy ; Neoplasm Staging ; Prognosis ; Treatment Outcome
    Chemical Substances Biomarkers, Tumor
    Language English
    Publishing date 2020-06-01
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 2661518-6
    ISSN 2073-4409 ; 2073-4409
    ISSN (online) 2073-4409
    ISSN 2073-4409
    DOI 10.3390/cells9061370
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  3. Article: Impaired anti-HBV vaccine response in non-cirrhotic chronic HCV is not overcome by double dose regimen: randomized control trial.

    Medeiros, Roseane P / Terrault, Norah A / Mazo, Daniel F / Oliveira, Claudia P / Dodge, Jennifer / Zitelli, Patricia M / Lopes, Marta H / Carrilho, Flair J / Pessoa, Mário G

    Annals of hepatology

    2022  Volume 28, Issue 2, Page(s) 100891

    Abstract: Introduction and objectives: Some studies suggest chronic HCV infection diminishes responses to the anti-HBV vaccine. We evaluated the efficacy of double versus standard dose HBV vaccination among HCV patients without cirrhosis.: Patients and methods!# ...

    Abstract Introduction and objectives: Some studies suggest chronic HCV infection diminishes responses to the anti-HBV vaccine. We evaluated the efficacy of double versus standard dose HBV vaccination among HCV patients without cirrhosis.
    Patients and methods: 141 adults with untreated chronic HCV were randomized to HBV vaccination with double dose (40μg) or standard dose (20μg) at 0, 1 and 6 months; 70 healthy HCV-negative patients given standard dose served as controls. Vaccine response was defined by anti-HBs ≥10 mIU/mL.
    Results: 128 patients (60 double, 68 standard doses) completed the study. Patients were of median age 52 years, 61% female, 60% fibrosis <2 of 4, and 76% genotype 1 with median 6-log
    Conclusions: In HCV-infected patients without cirrhosis, impaired responses to HBV vaccination cannot be overcome by the use of double dose HBV vaccination, but adding a fourth dose of vaccine for non-responders may be an effective strategy. Other adjuvant measures are needed to enhance seroconversion rates in these patients.
    Trial register: U 1111-1264-2343 (www.ensaiosclinicos.gov.br).
    MeSH term(s) Adult ; Humans ; Female ; Middle Aged ; Male ; Hepatitis B Vaccines/adverse effects ; Hepatitis B Antibodies ; Vaccination ; RNA ; Hepatitis C
    Chemical Substances Hepatitis B Vaccines ; Hepatitis B Antibodies ; RNA (63231-63-0)
    Language English
    Publishing date 2022-12-24
    Publishing country Mexico
    Document type Randomized Controlled Trial ; Journal Article
    ZDB-ID 2188733-0
    ISSN 1665-2681
    ISSN 1665-2681
    DOI 10.1016/j.aohep.2022.100891
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  4. Article: Direct-acting antivirals for chronic hepatitis C treatment: The experience of two tertiary university centers in Brazil.

    Lourenço, Mariana Sandoval / Zitelli, Patricia Momoyo Y / Cunha-Silva, Marlone / Oliveira, Arthur Ivan N / Oliveira, Cláudia P / Sevá-Pereira, Tiago / Carrilho, Flair José / Pessoa, Mario G / Mazo, Daniel F

    World journal of hepatology

    2021  Volume 14, Issue 1, Page(s) 195–208

    Abstract: Background: Hepatitis C virus (HCV) treatment has undergone major changes in recent years. Previous interferon-based therapies have been replaced by oral direct-acting antivirals (DAA) regimens, with high sustained virologic response (SVR) rates, and a ... ...

    Abstract Background: Hepatitis C virus (HCV) treatment has undergone major changes in recent years. Previous interferon-based therapies have been replaced by oral direct-acting antivirals (DAA) regimens, with high sustained virologic response (SVR) rates, and a lower incidence of adverse events (AEs).
    Aim: To evaluate the efficacy and safety of DAAs for HCV treatment in subjects from two tertiary university centers in Brazil.
    Methods: This is a multicenter retrospective cohort study of 532 patients with chronic hepatitis C (CHC), undergoing treatment with interferon-free regimens from November 2015 to November 2019. The therapeutic regimen was defined by the current Brazilian guidelines for HCV management at the time of treatment. Demographic, anthropometric, clinical, and laboratory variables were evaluated. SVRs were assessed at 12 to 24 wk after therapy by intention-to-treat (ITT), and modified ITT (m-ITT) analysis. AEs and serious adverse events (SAEs) were registered. In the statistical analysis, a
    Results: The mean age was 56.88 years, with 415 (78.5%) being HCV genotype 1, followed by genotype 3 (20.1%). Moreover, 306 (57.5%) subjects had cirrhosis, and a third of them had decompensated cirrhosis. Sofosbuvir (SOF) plus daclatasvir ± ribavirin was the most frequently used treatment (66.9%), followed by SOF plus simeprevir (21.2%). The overall ITT SVR was 92.6% (493/532), while the m-ITT SVR was 96.8% (493/509). Variables associated with treatment failure
    Conclusion: Treatment with oral DAAs attains a high SVR rate, with fewer SAEs in a real-life cohort of subjects with CHC, from two tertiary university centers in Brazil.
    Language English
    Publishing date 2021-12-15
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2573703-X
    ISSN 1948-5182
    ISSN 1948-5182
    DOI 10.4254/wjh.v14.i1.195
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  5. Article ; Online: Early liver function improvement following successful treatment of chronic hepatitis C in patients with decompensated cirrhosis: a real-life study.

    Lourenço, Mariana Sandoval / Zitelli, Patricia Momoyo Y / Cunha-Silva, Marlone / Oliveira, Arthur Ivan N / Lima, Roque Gabriel Rezende de / Souza, Evandro de Oliveira / Oliveira, Claudia P / Sevá-Pereira, Tiago / Carrilho, Flair J / Pessoa, Mario G / Mazo, Daniel F

    Clinics (Sao Paulo, Brazil)

    2021  Volume 76, Page(s) e3186

    Abstract: Objectives: Despite higher rates of sustained virologic response (SVR), important concerns remain when patients with decompensated cirrhosis due to hepatitis C virus (HCV) are treated with direct-acting antiviral agents (DAA). Questions include efficacy, ...

    Abstract Objectives: Despite higher rates of sustained virologic response (SVR), important concerns remain when patients with decompensated cirrhosis due to hepatitis C virus (HCV) are treated with direct-acting antiviral agents (DAA). Questions include efficacy, safety, and the magnitude of liver function improvement. Here, we aimed to evaluate HCV treatment data in this specific population in Brazil.
    Methods: We included 85 patients with decompensated cirrhosis submitted to HCV therapy with DAA followed at two academic tertiary centers in the southeastern region of Brazil.
    Results: Seventy-nine patients (92.9%) were Child-Pugh (CP) score B, and six (7.1%) were CP score C. The mean MELD score was 12.86. The most common treatment was sofosbuvir plus daclatasvir±ribavirin for 24 weeks. The overall intention-to-treat (ITT) SVR rate was 87.4% (74/85) and modified-ITT 96.1% (74/77). ITT SVR was associated with lower baseline INR values (p=0.029). Adverse events (AE) occurred in 57.9% (44/76) of patients. Serious AE were reported in 12.8% (10/78), and were related to the presence of hepatic encephalopathy (p=0.027). SVR was associated with improvement in CP (p<0.0001) and MELD scores (p=0.021). Among baseline CP score B patients with SVR, 46% (29/63) regressed to CP score A. Ascites was independently associated with no improvement in liver function in patients who achieved SVR (p=0.001; OR:39.285; 95% CI:4.301-258.832).
    Conclusions: Patients with decompensated HCV cirrhosis showed a high SVR rate with interferon-free therapy. Early liver function improvement occurred after successful HCV eradication. However, long-term follow-up of these patients after SVR remains strongly advised.
    MeSH term(s) Antiviral Agents/therapeutic use ; Drug Therapy, Combination ; Hepacivirus ; Hepatitis C, Chronic/complications ; Hepatitis C, Chronic/drug therapy ; Humans ; Liver Cirrhosis/complications ; Liver Cirrhosis/drug therapy ; Ribavirin/therapeutic use ; Sustained Virologic Response ; Treatment Outcome
    Chemical Substances Antiviral Agents ; Ribavirin (49717AWG6K)
    Language English
    Publishing date 2021-11-19
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2182801-5
    ISSN 1980-5322 ; 1807-5932
    ISSN (online) 1980-5322
    ISSN 1807-5932
    DOI 10.6061/clinics/2021/e3186
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  6. Article ; Online: The role of PNPLA3 and TM6SF2 polymorphisms on liver fibrosis and metabolic abnormalities in Brazilian patients with chronic hepatitis C.

    Oliveira, Arthur Ivan N / Malta, Fernanda M / Zitelli, Patricia Momoyo Y / Salles, Ana Paula M / Gomes-Gouvea, Michele S / Nastri, Ana Catharina S / Pinho, Joao Renato R / Carrilho, Flair J / Oliveira, Claudia P / Mendes-Corrêa, Maria Cássia / Pessoa, Mario G / Mazo, Daniel F

    BMC gastroenterology

    2021  Volume 21, Issue 1, Page(s) 81

    Abstract: Background: Despite the growing body of knowledge about TM6SF2 and PNPLA3 polymorphisms in non-alcoholic fatty liver disease, their influence in the spectrum of HCV liver disease is not yet fully defined. Besides that, admixed populations, such as ... ...

    Abstract Background: Despite the growing body of knowledge about TM6SF2 and PNPLA3 polymorphisms in non-alcoholic fatty liver disease, their influence in the spectrum of HCV liver disease is not yet fully defined. Besides that, admixed populations, such as Brazilians, were not included in most of the studies.
    Methods: This cross-sectional study enrolled 365 treatment-naïve patients with HCV and 134 healthy individuals. TM6SF2 (rs58542926 c.499C > T) and PNPLA3 (rs738409 c.444C > G) polymorphisms were evaluated regarding their association with clinical and laboratory data, histological liver steatosis and fibrosis, and with components of the metabolic syndrome.
    Results: In HCV subjects, the frequencies of TM6SF2 CC and CT + TT were 89% and 11%, while PNPLA3 frequencies of CC and CG + GG were 51.4% and 48.6%. In the univariate logistic regression analysis, the TM6SF2 CT + TT genotype in HCV was associated with significant liver fibrosis (p = 0.047; OR 1.953; 95% CI 1.009-3.788). In comparison to the CT + TT genotype, the TM6SF2 CC genotype in HCV was associated with older age (p = 0.002), higher frequency of arterial hypertension (p = 0.032), obesity (p = 0.030), metabolic syndrome (p = 0.014) and lower total cholesterol levels (p = 0.036). The PNPLA3 GG subjects had lower body mass index than CG/ CC individuals (p = 0.047). None of the polymorphisms, or their combinations, was independently associated with hepatic steatosis or fibrosis. On the other hand, older age, lower serum levels of total cholesterol, and higher serum levels of alanine aminotransferase and alkaline phosphatase were associated with liver fibrosis in the multivariate logistic regression analysis.
    Conclusion: In this evaluation of an admixed HCV population, neither TM6SF2 nor PNPLA3 polymorphisms were independently associated with hepatic steatosis or fibrosis. Other factors seem more influential than these specific polymorphisms in isolation. More studies are warranted to clarify the role of the TM6SF2 and PNPLA3 polymorphisms in Brazilians with HCV.
    MeSH term(s) Aged ; Brazil ; Cross-Sectional Studies ; Genetic Predisposition to Disease ; Genotype ; Hepatitis C, Chronic/genetics ; Hepatitis C, Chronic/pathology ; Humans ; Lipase/genetics ; Liver/pathology ; Liver Cirrhosis/genetics ; Liver Cirrhosis/pathology ; Membrane Proteins/genetics ; Non-alcoholic Fatty Liver Disease/genetics ; Non-alcoholic Fatty Liver Disease/pathology ; Polymorphism, Single Nucleotide
    Chemical Substances Membrane Proteins ; TM6SF2 protein, human ; Lipase (EC 3.1.1.3) ; adiponutrin, human (EC 3.1.1.3)
    Language English
    Publishing date 2021-02-23
    Publishing country England
    Document type Journal Article
    ZDB-ID 2041351-8
    ISSN 1471-230X ; 1471-230X
    ISSN (online) 1471-230X
    ISSN 1471-230X
    DOI 10.1186/s12876-021-01654-3
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  7. Article ; Online: Uniting to defeat steatotic liver disease: A global mission to promote healthy livers and healthy lives.

    Krag, Aleksander / Buti, Maria / Lazarus, Jeffrey V / Allen, Alina M / Bowman, Jacqueline / Burra, Patrizia / Donnini, Giacomo / Duseja, Ajay / El-Sayed, Manal H / Gastaldelli, Amalia / Hainsworth, Ben / Karlsen, Tom H / Kessler, Michael / Korenjak, Marko / Mark, Henry E / Mann, Jake P / Miller, Veronica / Pessoa, Mário G / Piñeiro, Daniel /
    Sarin, Shiv K / Singh, Shivaram P / Rinella, Mary E / Willemse, José / Younossi, Zobair M / Francque, Sven M

    Journal of hepatology

    2023  Volume 79, Issue 5, Page(s) 1076–1078

    Language English
    Publishing date 2023-08-25
    Publishing country Netherlands
    Document type Editorial
    ZDB-ID 605953-3
    ISSN 1600-0641 ; 0168-8278
    ISSN (online) 1600-0641
    ISSN 0168-8278
    DOI 10.1016/j.jhep.2023.07.029
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  8. Article: HAV and HBV seroprevalence in 1,000 patients with chronic HCV infection in a Tertiary Care Center in São Paulo, Brazil.

    da Silva, Edvaldo F / Mazo, Daniel F / Oliveira, Claudia P / Medeiros, Roseane P / Carrilho, Flair J / Pessôa, Mário G

    Annals of hepatology

    2016  Volume 15, Issue 5, Page(s) 691–695

    Abstract: Unlabelled:  Background. Patients with chronic HCV infection and superinfection by hepatitis A virus (HAV) or hepatitis B virus (HBV) have higher morbidity and mortality when compared with those without HCV infection. Therefore, HAV and HBV active ... ...

    Abstract Unlabelled:  Background. Patients with chronic HCV infection and superinfection by hepatitis A virus (HAV) or hepatitis B virus (HBV) have higher morbidity and mortality when compared with those without HCV infection. Therefore, HAV and HBV active immunization has become mandatory in this population and hence their serological markers must be determined. The aim of this study was to evaluate the prevalence of serological markers of HAV and HBV infection in patients with chronic HCV.
    Material and methods: One thousand chronic HCV patients at the University of São Paulo School of Medicine were evaluated for the prevalence of serological markers of HAV and HBV infection.
    Results: Anti-HAV IgG was positive in 92.3% of patients. When stratified by age, anti-HAV IgG was found in 61% of patients between 20-29 years, 70% on patients between 30-39 years, 85% on patients between 40-49 years, 94% on patients between 50-59 years, and in 99% on patients over 60 years of age. Anti-HBc IgG was positive in 244 patients (24%). Stratified by age, in 4.3% of patients between 20-29 years, 17% 30-39 years, 21% 40-49 years, 24% 50-59 years, and in 28% of patients over 60 years. Of the 244 anti-HBc IgG positive patients, 0.8% were HBsAg positive, 8.5% were anti-HBc IgG isolated and 16% were also anti-HBs positive.
    Conclusions: In conclusion, the prevalence of anti-HAV IgG was similar to the general Brazilian population. However, anti-HBc IgG was higher in our patients, when compared to general population of Western countries, emphasizing the importance of immunization programs for this population.
    MeSH term(s) Adult ; Aged ; Biomarkers/blood ; Brazil/epidemiology ; Coinfection ; Female ; Hepatitis A/blood ; Hepatitis A/diagnosis ; Hepatitis A/epidemiology ; Hepatitis A Antibodies/blood ; Hepatitis B/blood ; Hepatitis B/diagnosis ; Hepatitis B/epidemiology ; Hepatitis B Antibodies/blood ; Hepatitis B Core Antigens/immunology ; Hepatitis C, Chronic/blood ; Hepatitis C, Chronic/diagnosis ; Hepatitis C, Chronic/epidemiology ; Humans ; Immunoglobulin G/blood ; Male ; Middle Aged ; Prevalence ; Prospective Studies ; Retrospective Studies ; Seroepidemiologic Studies ; Serologic Tests ; Superinfection ; Tertiary Care Centers ; Young Adult
    Chemical Substances Biomarkers ; Hepatitis A Antibodies ; Hepatitis B Antibodies ; Hepatitis B Core Antigens ; Immunoglobulin G
    Language English
    Publishing date 2016-09
    Publishing country Mexico
    Document type Evaluation Studies ; Journal Article
    ZDB-ID 2188733-0
    ISSN 1665-2681
    ISSN 1665-2681
    DOI 10.5604/16652681.1212320
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  9. Article ; Online: The Latin American Association for the Study of the Liver (ALEH) position statement on the redefinition of fatty liver disease.

    Mendez-Sanchez, Nahum / Arrese, Marco / Gadano, Adrian / Oliveira, Claudia P / Fassio, Eduardo / Arab, Juan Pablo / Chávez-Tapia, Norberto C / Dirchwolf, Melisa / Torre, Aldo / Ridruejo, Ezequiel / Pinchemel-Cotrim, Helma / Castellanos Fernández, Marlen Ivón / Uribe, Misael / Girala, Marcos / Diaz-Ferrer, Javier / Restrepo, Juan C / Padilla-Machaca, Martín / Dagher, Lucy / Gatica, Manuel /
    Olaechea, Blanca / Pessôa, Mario G / Silva, Marcelo

    The lancet. Gastroenterology & hepatology

    2020  Volume 6, Issue 1, Page(s) 65–72

    Abstract: The Latin American Association for the Study of the Liver (Asociación Latinoamericana para el Estudio del Hígado; ALEH) represents liver professionals in Latin America with the mission of promoting liver health and quality patient care by advancing the ... ...

    Abstract The Latin American Association for the Study of the Liver (Asociación Latinoamericana para el Estudio del Hígado; ALEH) represents liver professionals in Latin America with the mission of promoting liver health and quality patient care by advancing the science and practice of hepatology and contributing to the development of a regional health policy framework. Fatty liver disease associated with metabolic dysfunction is of specific concern in the ALEH region, where its prevalence is one of the highest globally, second only to the Middle East. A recent consensus from an international panel recommended a new definition of fatty liver disease associated with metabolic dysfunction, including a shift in name from non-alcoholic fatty liver disease (NAFLD) to metabolic-associated fatty liver disease (MAFLD), and adoption of a set of positive criteria to diagnose the disease, independent of alcohol intake or other liver diseases. Given, the importance of this proposal, ALEH invited leading members of regional nations to come to a consensus on it from a local perspective. We reached a consensus to endorse the proposal that the disease should be renamed as MAFLD and that the disease should be diagnosed by the proposed simple and easily applicable criteria. We expect that this change in nosology will result in improvements in disease awareness and in advances in scientific, economic, public health, political, and regulatory aspects of the disease.
    MeSH term(s) Consensus ; Humans ; Latin America/epidemiology ; Non-alcoholic Fatty Liver Disease/diagnosis ; Non-alcoholic Fatty Liver Disease/epidemiology ; Non-alcoholic Fatty Liver Disease/metabolism ; Prevalence ; Risk Factors ; Terminology as Topic
    Language English
    Publishing date 2020-11-09
    Publishing country Netherlands
    Document type Journal Article ; Review
    ISSN 2468-1253
    ISSN (online) 2468-1253
    DOI 10.1016/S2468-1253(20)30340-X
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  10. Article: Efficacy of telbivudine with conditional tenofovir intensification in patients with chronic hepatitis B: results from the 2-year roadmap strategy.

    Piratvisuth, Teerha / Komolmit, Piyawat / Chan, Henry Ly / Tanwandee, Tawesak / Sukeepaisarnjaroen, Wattana / Pessoa, Mário G / Fassio, Eduardo / Ono, Suzane K / Bessone, Fernando / Daruich, Jorge / Zeuzem, Stefan / Manns, Michael / Uddin, Alkaz / Dong, Yuhong / Trylesinski, Aldo

    Drugs in context

    2016  Volume 5, Page(s) 212294

    Abstract: Background: A 2-year roadmap study was conducted to evaluate the efficacy and safety of tenofovir intensification at Week 24 in patients with chronic hepatitis B (CHB) receiving telbivudine.: Scope: A prospective multicenter study was conducted in ... ...

    Abstract Background: A 2-year roadmap study was conducted to evaluate the efficacy and safety of tenofovir intensification at Week 24 in patients with chronic hepatitis B (CHB) receiving telbivudine.
    Scope: A prospective multicenter study was conducted in treatment-naive patients with hepatitis B e antigen (HBeAg)-positive CHB. All patients received telbivudine (600 mg/day) until Week 24. Thereafter, patients with detectable hepatitis B virus (HBV) DNA (≥300 copies/mL) were administered tenofovir (300 mg/day) plus telbivudine, and patients with undetectable HBV DNA continued telbivudine monotherapy until Week 104. The primary endpoint was the proportion of patients with undetectable HBV DNA (<300 copies/mL) at Weeks 52 and 104.
    Findings: A total of 105 patients were enrolled in the trial, of which 100 were eligible for efficacy analysis. Undetectable HBV DNA levels were observed at Week 24 in 55 patients who continued on with telbivudine monotherapy. The remaining 45 patients with detectable HBV DNA received tenofovir add-on therapy. With monotherapy, 100% (55/55) and 94.5% (52/55) of patients achieved HBV DNA <300 copies/mL at Weeks 52 and 104, respectively; the corresponding values for patients with add-on therapy were 84.4% (38/45) and 93.3% (42/45). Overall, undetectable HBV DNA (<300 copies/mL) was found in 93% (93/100) and 94% (94/100) of patients at Weeks 52 and 104, respectively. HBeAg seroconversion rate was 44.4% (44/99) at Week 104 for the overall patient population. One patient in the monotherapy group and six in the intensification group demonstrated HBsAg clearance at Week 104. HBsAg seroconversion was observed in four patients at Week 104, all belonged to the tenofovir intensification group. Eight patients sustained HBsAg loss during a posttreatment follow-up period of 16 weeks. Alanine aminotransferase (ALT) normalization was constant in the telbivudine monotherapy group, whereas a progressive improvement was observed in the tenofovir intensification group. Two patients in the monotherapy and none in the intensification group experienced viral breakthrough by Week 104. There were no reports of myopathy in either group. The mean changes in estimated glomerular filtration rate (eGFR), estimated using the Modification of Diet in Renal Disease (MDRD) formula, from baseline to Week 104 were +6.145 mL/min/1.73 m(2) (p=0.0230) and +7.954 mL/min/1.73 m(2) (p=0.0154) in the telbivudine monotherapy and tenofovir intensification groups, respectively. The incidence of serious AEs was four in the telbivudine monotherapy and two in the tenofovir intensification group. The main limitation of this study was limited sample size, which made the power of the observation low, and the absence of a comparative subgroup to assess the progression of patients with detectable HBV DNA without treatment intensification.
    Conclusions: Data from this 2-year roadmap study confirmed that telbivudine with add-on tenofovir was effective and well tolerated in patients with CHB. Telbivudine was associated with an improvement in eGFR from baseline in both the groups.
    Language English
    Publishing date 2016-04-22
    Publishing country England
    Document type Journal Article
    ZDB-ID 2719560-0
    ISSN 1740-4398 ; 1745-1981
    ISSN (online) 1740-4398
    ISSN 1745-1981
    DOI 10.7573/dic.212294
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