Efficacy and safety of entecavir for chronic HBV in HIV/HBV coinfected patients receiving lamivudine as part of antiretroviral therapy
| Autor: | Phillip Phiri, Mario G. Pessoa, Carlos Eduardo Brandão-Mello, Helena Brett-Smith, Brian Gazzard, Andrea Hall, Vicente Soriano, Anna K Huang, Maria Cassia Mendes-Correa, Isabel Cassetti |
|---|---|
| Rok vydání: | 2008 |
| Předmět: |
Adult
Male Hepatitis B virus medicine.medical_specialty Guanine Immunology HIV Infections Viremia Virus Replication Placebo medicine.disease_cause Antiviral Agents Gastroenterology Hepatitis B Chronic Antiretroviral Therapy Highly Active Internal medicine Drug Resistance Viral medicine Humans Immunology and Allergy Single-Blind Method biology Reverse-transcriptase inhibitor business.industry HIV virus diseases Lamivudine Entecavir Middle Aged Hepatitis B biology.organism_classification medicine.disease Virology Infectious Diseases DNA Viral Lentivirus Linear Models Drug Therapy Combination Female business Follow-Up Studies medicine.drug |
| Zdroj: | AIDS. 22:1779-1787 |
| ISSN: | 0269-9370 |
| DOI: | 10.1097/qad.0b013e32830b3ab5 |
| Popis: | Background: Prolonged use of lamivudine in patients coinfected with HIV and hepatitis B virus (HBV) leads to an increasing risk of lamivudine resistance in both diseases. We investigated the addition of entecavir, a potent inhibitor of HBV polymerase, to lamivudine-containing highly active antiretroviral therapy (HAART) in patients who experienced rebound in HBV viremia while maintaining suppression of plasma HIV RNA less than 400 copies/ml. Methods: Sixty-eight patients were randomized to entecavir 1 mg (n=51) or placebo (n = 17) once daily for 24 weeks; 65 patients continued the study with entecavir for an additional 24 weeks. Lamivudine-containing HAART was continued throughout. Results: At week 24, the mean HBV DNA in entecavir-treated patients was 5.52 log 10 -copies/ml versus 9.27 log 10 copies/ml for placebo, and atweek48, it was 4.79 log 10 copies/ ml versus 5.63 log 10 copies/ml, respectively. The mean HBV DNA change from baseline for entecavir was -3.65 log 10 copies/ml (versus + 0.11 for placebo, P < 0.0001) and alanine aminotransferase normalization in 34% of patients (versus 8% for placebo, P = 0.08). At48 weeks, mean change in H BV DNA reached -4.20 log 10 copies/ml in patients who received entecavir for the entire 48 weeks. The frequency of adverse events with entecavir and placebo was comparable. Through 48 weeks, no clinically relevant changes in HIV viremia or CD4 cell counts were identified. Conclusion: In this study, entecavir was associated with rapid, clinically significant reductions in HBV DNA, with maintenance of HIV viremia suppression, in HIV/HBV coinfected patients with HBV viremia while on lamivudine treatment. |
| Databáze: | OpenAIRE |
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