A Review of the Efficacy and Safety of Genvoya® (Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide) in the Management of HIV-1 Infection

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.

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Bone mineral density in virologically suppressed people aged 60 years or older with HIV-1 switching from a regimen containing tenofovir disoproxil fumarate to an elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide single-tablet regimen: a multicentre, open-label, phase 3b, randomised trial

The Lancet HIV ◽

10.1016/s2352-3018(19)30195-x ◽

2019 ◽

Vol 6 (10) ◽

pp. e655-e666 ◽

Cited By ~ 3

Author(s):

Franco Maggiolo ◽

Giuliano Rizzardini ◽

François Raffi ◽

Federico Pulido ◽

Maria Gracia Mateo-Garcia ◽

...

Keyword(s):

Bone Mineral Density ◽

Bone Mineral ◽

Tenofovir Disoproxil Fumarate ◽

Randomised Trial ◽

Mineral Density ◽

Open Label ◽

Single Tablet Regimen ◽

Open Label Phase ◽

Tenofovir Alafenamide ◽

Hiv 1

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Efficacy and Safety of Denosumab in Osteoporosis or Low Bone Mineral Density Postmenopausal Women

Frontiers in Pharmacology ◽

10.3389/fphar.2021.588095 ◽

2021 ◽

Vol 12 ◽

Author(s):

Yi Chen ◽

Jun Zhu ◽

Yiqin Zhou ◽

Jinhui Peng ◽

Bo Wang

Keyword(s):

Bone Mineral Density ◽

Adverse Events ◽

Postmenopausal Women ◽

Bone Mineral ◽

Human Monoclonal Antibody ◽

Safety Data ◽

Cochrane Library ◽

Efficacy And Safety ◽

Mineral Density ◽

Low Bone Mineral Density

Denosumab, a human monoclonal antibody, acts against the receptor activator of nuclear factor-κB ligand and is a promising antiresorptive agent in patients with osteoporosis. This study aimed to update the efficacy and safety of denosumab vs. placebo in osteoporosis or low bone mineral density (BMD) postmenopausal women. PubMed, Embase, Cochrane library, and ClinicalTrials.gov were searched for randomized controlled trials (RCTs) reporting the efficacy and safety data of denosumab vs. placebo in osteoporosis or low BMD postmenopausal women. A random-effects model was used to calculate pooled weight mean differences (WMDs) or relative risks (RRs) with corresponding 95% confidence intervals (CIs) for treatment effectiveness of denosumab vs. placebo. Eleven RCTs including 12,013 postmenopausal women with osteoporosis or low BMD were preferred for the final meta-analysis. The summary results indicated that the percentage change of BMD in the denosumab group was greater than that of BMD in placebo at 1/3 radius (WMD: 3.43; 95%CI: 3.24–3.62; p < 0.001), femoral neck (WMD: 3.05; 95%CI: 1.78–4.33; p < 0.001), lumbar spine (WMD: 6.25; 95%CI: 4.59–7.92; p < 0.001), total hip (WMD: 4.36; 95%CI: 4.07–4.66; p < 0.001), trochanter (WMD: 6.00; 95%CI: 5.95–6.05; p < 0.001), and total body (WMD: 3.20; 95%CI: 2.03–4.38; p < 0.001). Moreover, denosumab therapy significantly reduced the risk of clinical fractures (RR: 0.57; 95%CI: 0.51–0.63; p < 0.001), nonvertebral fracture (RR: 0.83; 95%CI: 0.70–0.97; p = 0.018), vertebral fracture (RR: 0.32; 95%CI: 0.25–0.40; p < 0.001), and hip fracture (RR: 0.61; 95%CI: 0.37–0.98; p = 0.042). Finally, denosumab did not cause excess risks of adverse events. These findings suggested that postmenopausal women receiving denosumab had increased BMDs and reduced fractures at various sites without inducing any adverse events.

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