Lamivudine plus dolutegravir improves bone mineral density compared to emtricitabine/tenofovir alafenamide plus an integrase inhibitor

Author(s):  
Arturo Ciccullo ◽  
Gianmaria Baldin ◽  
Vanni Borghi ◽  
Anna Pia Lassandro ◽  
Damiano Farinacci ◽  
...  
2017 ◽  
Vol 31 (2) ◽  
pp. 216-221 ◽  
Author(s):  
Sara A. Angione ◽  
Sibyl M. Cherian ◽  
Ayşe Elif Özdener

Introduction: This review evaluates the efficacy and safety of Genvoya® (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide [EVG/c/TAF/FTC]), a single-tablet regimen used for the management of HIV-1 infection. Phase II and III randomized clinical trials evaluate the efficacy and safety of EVG/c/TAF/FTC and tenofovir disoproxil fumerate (TDF)–containing arms; renal impairment, bone mineral density, metabolic effects, and other adverse events are topics explored within this review. Methods: A MEDLINE with full text and PubMed literature search was conducted for the past 5 years, up to April 2016. Results: Virologic suppression was similar between the EVG/c/TAF/FTC and TDF-containing groups (<50 copies/mL) at week 48. The bone mineral density in the hip and spine showed a significant reduction in the TDF-containing groups. The glomerular filtration rate increased in patients in the EVG/c/TAF/FTC arm and there were significant differences in total proteinuria, albuminuria, and tubular proteinuria in patients switching to EVG/c/TAF/FTC. The most common adverse events were diarrhea, nausea, and headache. Discussion: The coformulated Genvoya regimen is well tolerated and effective in treatment-naive and virologically suppressed patients. Data seem to suggest it may also be effective and safe in patients with mild to moderate renal impairment. The lower-dosed single-tablet regimen has significantly reduced bone and renal side effects.


2019 ◽  
Vol 74 (9) ◽  
pp. 2742-2751 ◽  
Author(s):  
Christine Katlama ◽  
Lambert Assoumou ◽  
Marc-Antoine Valantin ◽  
Cathia Soulié ◽  
Esteban Martinez ◽  
...  

Abstract Background Dual therapy combining integrase inhibitors and NNRTIs represents a promising regimen in ageing HIV-infected individuals with long exposure to nucleoside analogues and PIs. Methods The ANRS 163 ETRAL trial (NCT02212379) was a 96 week, multicentre, single-arm study evaluating the efficacy and safety of raltegravir (400 mg twice daily)/etravirine (200 mg twice daily) in individuals >45 years, on a PI-containing regimen who were integrase inhibitor and etravirine naive. The primary endpoint was the proportion of participants with virological success, defined by the absence of virological failure up to week 48. Main secondary outcomes included evolution of metabolic parameters, CD4/CD8 count, bone mineral density and inflammatory markers. The study was designed to show an efficacy >90%, assuming a success rate ≥95%, with a power of 80% and a 5% type-1 error. Results One hundred and sixty-five participants (median age 52 years, duration of ART 16.9 years, viral suppression 6.9 years and CD4 count 700 cells/mm3) were enrolled. By ITT analysis, viral suppression was maintained in 99.4% of participants (95% CI = 95.6%–99.9%) at week 48 and 98.7% (95% CI = 95.0%–99.7%) at week 96. Two virological failures occurred (week 24 and week 64) without emergence of integrase inhibitor resistance. Eight participants discontinued raltegravir/etravirine for adverse events, leading to a strategy success rate of 95.1% (95% CI = 90.5%–97.5%) at week 48 and 92.7% (95% CI = 87.5%–95.8%) at week 96. Over 96 weeks, lipid fractions improved (P < 0.001), CD4/CD8 ratio increased, IFNγ-induced protein 10 (IP-10) decreased (−8.1%), soluble CD14 decreased (−27%, P < 0.001) bone mineral density improved and BMI increased. Conclusions Raltegravir plus etravirine dual therapy demonstrated durable efficacy in virologically suppressed ageing patients.


2001 ◽  
Vol 120 (5) ◽  
pp. A564-A564
Author(s):  
K ISLAM ◽  
S CREECH ◽  
R SOKHI ◽  
R KONDAVEETI ◽  
A NADIR ◽  
...  

2006 ◽  
Vol 175 (4S) ◽  
pp. 41-42
Author(s):  
Anna Orsola ◽  
Jacques Planas ◽  
Carlos Salvador ◽  
José M. Abascal ◽  
Enrique Trilla ◽  
...  

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