Clinical experience with dolutegravir/abacavir/lamivudine in HIV-HCV co-infected patients treated with a sofosbuvir-based regimen-safety and efficacy
Autor: | Tamara M Johnson, Raymund Sison, Herbert Galang, Jihad Slim, Richard Habeeb, James P Fallon, Sristi Bhattarai, Prerak Shukla |
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Rok vydání: | 2016 |
Předmět: |
Ledipasvir
Simeprevir Male medicine.medical_specialty Sofosbuvir Pyridones HIV Infections Hepacivirus Piperazines 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Abacavir Internal medicine Antiretroviral Therapy Highly Active Oxazines medicine Humans Pharmacology (medical) 030212 general & internal medicine business.industry Coinfection Lamivudine Abacavir/Lamivudine Middle Aged Viral Load Virology Hepatitis C Dideoxynucleosides CD4 Lymphocyte Count Regimen Infectious Diseases Treatment Outcome chemistry Dolutegravir HIV-1 030211 gastroenterology & hepatology Drug Therapy Combination Female business Heterocyclic Compounds 3-Ring medicine.drug |
Zdroj: | HIV clinical trials. 17(6) |
ISSN: | 1945-5771 |
Popis: | There is no known reason to suspect an adverse drug interaction between dolutegravir-based antiretroviral therapy and sofosbuvir, simeprevir, or ledipasvir. There is a paucity of clinical data for this combination.Prospective, open-label study of patients with HIV well controlled on dolutegravir, abacavir, and lamivudine, who were co-infected with HCV genotype 1, and required therapy with simeprevir plus sofosbuvir or sofosbuvir/ledipasvir single-tablet regimen (STR) for 12 weeks. The two primary endpoints were percentage of patients achieving sustained virologic response (SVR) at 12 weeks post-treatment and percentage of patients with a HIV-1 viral load 50 copies/ml at end of the combination therapy.Twenty-eight subjects were enrolled from August 2014 to September 2015. Thirteen patients were treated with simprevir plus sofosbuvir, and 15 subjects were treated with sofosbuvir/ledipasvir. 23 genotype 1a, and 5 genotype 1b were included. Nineteen were treatment naïve, and 2 patients had compensated cirrhosis. The mean age was 59 years (95% CI 58.21-59.78 years). The mean age was 59 years (95% CI: 58.21-59.78 years), and 25 patients were black. Out of the 28 patients who completed this study, SVR 12 was achieved in 27 of 28 patients (96%, 95% CI 89.6-100.0%), and all patients had an HIV virus load 50 copies/ml at week 12 of therapy, for an intent-to-treat rate of 100%. No patients ended therapy secondary to adverse events.Our study suggests a good safety and efficacy for the combination of a dolutegravir, abacavir, and lamivudine with sofosbuvir-based DAA therapy. |
Databáze: | OpenAIRE |
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