Pharmacokinetics and 48-week safety and efficacy of generic ritonavir tablet-boosted atazanavir in HIV-1-infected Thai adults
| Autor: | Mathus Sawpitiporn, Jiratchaya Sophonphan, Sivaporn Gatechompol, Busarat Karachot, Bancha Chuasuwan, Mariam Duereh, Kiat Ruxrungtham, Isariya Techatanawat, Chutima Manamuti, Akarin Hiransuthikul, Hiv-Nat study team, Anchalee Avihingsanon, Narukjaporn Thammajaruk, Chureeratana Bowonwattanuwong |
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| Rok vydání: | 2018 |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors Anti-HIV Agents Atazanavir Sulfate Human immunodeficiency virus (HIV) HIV Infections medicine.disease_cause Pharmacokinetics Internal medicine medicine Drugs Generic Humans Pharmacology (medical) Pharmacology Ritonavir business.industry Middle Aged Atazanavir Infectious Diseases Treatment Outcome HIV-1 Female Drug Monitoring business medicine.drug Tablets |
| Zdroj: | Antiviral therapy. 23(8) |
| ISSN: | 2040-2058 |
| Popis: | Background Ritonavir (RTV) tablets were not available in Thailand until they were manufactured by the Government Pharmaceutical Organization of Thailand. We assessed pharmacokinetics (PK), safety and efficacy of generic RTV-boosted atazanavir (ATV) in virologically suppressed HIV-1-infected Thai adults. Methods Virologically suppressed HIV-1-infected Thai adults who currently use ATV (either 200 or 300 mg) with Norvir® soft gel capsule (SGC) 100-mg-based regimen were enrolled into this prospective, 48-week single-arm study. Participants switched from Norvir® SGC to generic RTV. Plasma trough concentration (C) was assessed at trough baseline before switching to generic RTV and week 24 in all participants, with the target ATV C of 0.15 mg/l. trough Plasma HIV-1 RNA and other laboratory safety parameters were assessed until week 48. Results Of 100 participants (51% male) enrolled, 50% was using ATV 200 mg and 50% was using 300 mg at the time RTV SGC were changed into generic tablets. All participants used two nucleoside reverse transcriptase inhibitors (NRTIs) as backbone. There were no significant changes in mean (sd) Ctrough of RTV (0.20 [0.33] versus 0.23 [0.39]; P=0.21) and ATV (0.83 [0.93] versus 0.88 [0.95]; P=0.62) between baseline and week 24. From entry to week 48, median alanine aminotransferase significantly increased from 25 to 30 IU/l ( P=0.001) and total bilirubin significantly decreased from 1.7 to 1.3 ( P=0.04). One study drug related grade 3 adverse event was reported. All but one participant maintained plasma HIV-1 RNA Conclusions Generic RTV-boosted ATV showed adequate levels, good tolerability and great efficacy after 48 weeks. |
| Databáze: | OpenAIRE |
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