Impact of switching virologically suppressed, HIV-1-infected patients from twice-daily fixed-dose zidovudine/lamivudine to once-daily fixed-dose tenofovir disoproxil fumarate/emtricitabine
| Autor: | Roberto Corales, John P. Flaherty, Shetal Sharma, Homayoun Khanlou, Cheryl McDonald, Edwin DeJesus, Ramin Ebrahimi, Peter Ruane, Fernando Garcia, Janet Ecker, David Shamblaw, Jayashree Ravishankar |
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| Rok vydání: | 2008 |
| Předmět: |
Adult
Male medicine.medical_specialty Efavirenz Metabolic Clearance Rate Organophosphonates Renal function HIV Infections Pharmacology Emtricitabine Gastroenterology Deoxycytidine chemistry.chemical_compound Zidovudine Hemoglobins Internal medicine medicine Humans Pharmacology (medical) Adverse effect Tenofovir Aged business.industry Adenine Lamivudine Middle Aged Viral Load Lipids Infectious Diseases Treatment Outcome chemistry Tolerability Anti-Retroviral Agents Patient Satisfaction Creatinine HIV-1 Quality of Life Patient Compliance RNA Viral Female business Viral load medicine.drug |
| Zdroj: | HIV clinical trials. 9(2) |
| ISSN: | 1528-4336 |
| Popis: | Evaluate the impact of switching from twice-daily zidovudine/lamivudine (AZT/3TC) to once-daily tenofovir DF plus emtricitabine (TDF/FTC) with efavirenz (EFV).Prospective, multicenter, single-arm 24-week trial.Patients on EFV + AZT/3TC foror =8 weeks with HIV-1 RNA400 copies/mL were switched to EFV + TDF/FTC and assessed for safety/tolerability, virologic and immunologic responses, adherence, and quality of life at 4, 12, and 24 weeks.Of 402 patients, 2% discontinued for an adverse event (AE) and 1 patient for virologic failure. At 24 weeks, 87% had HIV RNA400 copies/mL, and 74% versus 71% at baseline had undetectable (HIV RNA50 copies/mL) viral load (ITT; M=F). Treatment-emergent AEs were infrequent (or = 5%) with gastrointestinal complaints being the most common. At 24 weeks compared to baseline, hemoglobin (Hb) increased by a median of 0.6 g/dL (p.001), and a decrease in creatinine clearance of 7.6 mL/min (p.001) was observed. Fasting lipids decreased slightly (p.02) in a subset of patients studied (n = 160). A higher percentage of patients reported being "very satisfied" with treatment and the absence of regimen side effects at 24 weeks versus baseline (p.001). At 24 weeks, 86% of patients tookor = 95% of doses versus 78% at baseline (p = .002).Patients switched to EFV + TDF/FTC maintained virologic suppression and the regimen was well tolerated. Patients reported increased satisfaction with treatment and fewer were bothered by side effects. |
| Databáze: | OpenAIRE |
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