This study assesses virologic response, safety, tolerability, and changes in health-related quality of life (HRQoL) in antiretroviral (ARV)-naive patients treated with 2 atazanavir (ATV)-based regimens over 96 weeks. Treatment-naive adult patients (n = 200) were randomized to receive either ATV 300 mg with ritonavir (RTV) 100 mg (ATV300/r, n = 95) or ATV 400 mg (ATV400; n = 105). At week 96, 75% of ATV300/r-treated and 70% of ATV400-treated patients achieved viral loads <400 copies/mL (difference estimate [95% confidence interval, CI] = 5.1 [-7.1 to 17.2]). Five and 20 patients, respectively, experienced virologic failure. Adverse event-related discontinuations occurred among 8% receiving ATV300/r and 3% receiving ATV400. Plasma lipid elevations were generally low. Both regimens were well tolerated and associated with sustained improvements in HRQoL. These findings demonstrate long-term efficacy, tolerability, and safety of both ATV300/r and ATV400 in ARV-naive patients through 96 weeks with improvements in HRQoL.
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http://dx.doi.org/10.1177/1545109709355828 | DOI Listing |
Infect Dis Ther
January 2025
ViiV Healthcare, Madrid, Spain.
Introduction: Dolutegravir (DTG) + lamivudine (3TC) demonstrated high rates of virologic suppression (VS) and low rates of virologic failure (VF), discontinuation, and drug resistance in randomized trials. Real-world evidence can support treatment effectiveness, safety, and tolerability in clinical practice and aid in treatment decisions.
Methods: A systematic literature review (SLR) was conducted to identify studies using DTG + 3TC (January 2013-March 2024).
Clin Gastroenterol Hepatol
December 2024
Health Services Research, Durham University, Durham, United Kingdom.
Background & Aims: Budesonide orodispersible tablets (BOT) have been shown to be safe and effective in phase III double-blind trials of induction and 48-week maintenance therapy of eosinophilic esophagitis (EoE). We now analyzed the long-term efficacy and safety of BOT in a 96-week open-label extension (OLE) study.
Methods: All patients with EoE in the 48-week double-blind maintenance study were eligible to receive BOT treatment for up to 96 weeks.
Zhonghua Gan Zang Bing Za Zhi
October 2024
Key Laboratory of Infectious Diseases Research in South China, Ministry of Education, Nanfang Hospital, Southern Medical University, Guangzhou510515, China.
In chronic hepatitis B (CHB) patients with previous 96-week treatment with tenofovir amibufenamide (TMF) or tenofovir disoproxil fumarate (TDF), we investigated the efficacy of sequential TMF treatment from 96 to 144 weeks. Enrolled subjects who were previously assigned (2:1) to receive either 25 mg TMF or 300 mg TDF with matching placebo for 96 weeks received extended or switched TMF treatment for 48 weeks. Efficacy was evaluated based on virological, serological, biological parameters, and fibrosis staging.
View Article and Find Full Text PDFJ Antimicrob Chemother
January 2025
Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Background: Antiretroviral therapy (ART) is recommended for all individuals with HIV infection, including those with acute HIV-1 infection (AHI). While recommendations are similar to those for chronic infection, efficacy data regarding treatment of acute HIV is limited.
Methods: This was a single arm, 96-week study of a once-daily integrase inhibitor (INSTI)-based regimen using elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) in AHI.
Biomedicines
October 2024
Unit of Infectious Diseases, ARNAS Garibaldi Hospital, Department of Clinical and Experimental Medicine, University of Catania, 95122 Catania, Italy.
: Out of 39.9 million adults living with HIV in 2022, 20 million were women. Despite bearing a significant burden, women remain underrepresented in clinical trials, including those for antiretroviral treatments (ART).
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