Randomized study evaluating the efficacy and safety of switching from an an abacavir/lamivudine-based regimen to an elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide single-tablet regimen

Rizzardini, Giuliano; Gori, Andrea; Miralles, Celia; Olalla, Julián; Molina, Jean Michel; Raffi, François; Kumar, Princy; Antinori, Andrea; Ramgopal, Moti; Stellbrink, Hans Jürgen; Das, Moupali; Chu, Hoa; Ram, Renee; Garner, Will; Shao, Yongwu; Chuck, Susan K.; Piontkowsky, David; Haubrich, Richard

doi:10.1097/qad.0000000000002244

Cited by 8 publications

(5 citation statements)

References 53 publications

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“…All five patients also had NRTI-associated resistance mutations which were already detected in genotypes before the switch in four out of five patients. This contrasts with previous reports where integrase inhibitor resistance was either not found at the time of failure or identified in a single patient in one study [ 8 , 9 , 18 – 20 ]. Our results are consistent with a low genetic barrier to resistance with elvitegravir as compared to second- generation integrase inhibitors.…”

Section: Discussioncontrasting

confidence: 99%

“…In our retrospective cohort study of PWH fully suppressed on ART, the proportion of patients maintaining a plasma HIV RNA level < 50 copies/mL one year after switching to E/C/F/TDF was 82.0%. This proportion remains however lower than that reported in randomized clinical trials where success rates above 93% have been reported with a switch to E/C/F/TDF or E/C/F/TAF [ 8 , 9 , 18 – 20 ]. These differences can be explained in part by a higher rate of patients discontinuing the study drugs because of drug-related adverse events, lost to follow-up or other reasons in our study (14.0% ) as compared to prior randomized trials (4–6%) [ 8 , 9 , 19 ].…”

Section: Discussionmentioning

confidence: 59%

“…These differences can also explain the higher rate of virologic failure in our study (3.5%) as compared to prior studies (1.0%) (Table 2) [8,9,18,20]. An additional reason for this higher rate of virologic non response is that we allowed patients with prior NRTI or integrase resistance mutations to be enrolled, whereas these patients were excluded from the analysis in prior randomized trials [8,9].…”

Section: Discussionmentioning

confidence: 83%

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Safety and efficacy of switching to elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate in treatment-experienced people with HIV: a multicenter cohort study

Castro

Brun²,

Sellier

et al. 2023

AIDS Res Ther

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Objectives We assessed the virologic efficacy of switching to co-formulated elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate (E/C/F/TDF) in patients with controlled HIV infection. Methods We conducted a retrospective multicenter observational cohort study including adult patients with controlled HIV-1 infection on any stable antiretroviral (ART) regimen, who switched to E/C/F/TDF. Success was measured by the proportion of patients with plasma viral load < 50 copies/ml at W48 using the FDA snapshot algorithm. We also assessed risk factors associated with virological failure (VF). Results 382 patients with HIV RNA < 50 copies/mL who switched to E/C/F/TDF were included in the study. Most patients (69.9%) were male, with median age 44 years (IQR 38–51), who had been on ART for a median of 7 years (IQR 4–13). Median CD4 count was 614/mm3 and 24.6% of the patients had a history of previous virological failure. The reasons for switching were simplification (67.0%) and tolerance issues (22.0%). At week 48, 314 (82.0% [95% CI 78.4–86.0]) patients had HIV RNA < 50 copies/mL, 13 (3.5% [95% CI 3.64–8.41]) experienced virological failure. Genotype at failure was available in 6/13 patients with detection of resistance-associated mutations to integrase inhibitors and NRTIs in 5/6 (83.3%) patients. We found no predictive factor associated with virological failure except for a borderline significance with the duration of viral suppression before the switch. Tolerability of E/C/F/TDF was good with 23/382 (6.0%) patients experiencing mild adverse reactions. Conclusion In our cohort, switching well-suppressed patients to E/C/F/TDF resulted in few virologic failures and was well tolerated. However, resistance to integrase inhibitors emerged in patients with virological failure.

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Section: Discussioncontrasting

confidence: 99%

Section: Discussionmentioning

confidence: 59%

Section: Discussionmentioning

confidence: 83%

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Safety and efficacy of switching to elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate in treatment-experienced people with HIV: a multicenter cohort study

Castro

Brun²,

Sellier

et al. 2023

AIDS Res Ther

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“…E/C/F/TAF was shown to increase adherence to ART and decrease the risk of drug resistance and virological failure. [1][2][3][4] However, another study showed a higher level of several lipid parameters in patients with tenofovir alafenamide (TAF)-based therapy compared with tenofovir (TDF)-based therapy in treatment-naïve and -experienced adults. [5] In 2019, a phase IV clinical study of E/C/F/TAF was conducted at our Antiviral Treatment Center, allowing us to explore the virological and immunological responses during 12 months of follow-up after switching.…”

mentioning

confidence: 99%

“…This single-tablet regimen provides a convenient, once-daily, treatment option for many PLWHA. E/C/F/TAF was shown to increase adherence to ART and decrease the risk of drug resistance and virological failure [1–4] . However, another study showed a higher level of several lipid parameters in patients with tenofovir alafenamide (TAF)-based therapy compared with tenofovir (TDF)-based therapy in treatment-naïve and -experienced adults [5] .…”

mentioning

confidence: 99%

Advantages of switching to elvitegravir/cobicistat/emtricitabine/tenofovir therapy in virologically-suppressed people living with human immunodeficiency virus/acquired immune deficiency syndrome

Fan

et al. 2022

Chinese Medical Journal

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Risk of dyslipidaemia in people living with HIV who are taking tenofovir alafenamide: a systematic review and meta‐analysis

Yoo,

Jung,

Kim

et al. 2024

J Int AIDS Soc.

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IntroductionAmong many antiretroviral drugs, tenofovir alafenamide is used extensively in combination regimens of tenofovir/emtricitabine or tenofovir/emtricitabine/bictegravir. However, concerns have arisen about the potential of tenofovir alafenamide to exacerbate hyperlipidaemia. This meta‐analysis evaluates the relationship between tenofovir alafenamide use and lipid‐profile alterations in people living with HIV.MethodsWe searched PubMed, Ovid MEDLINE, EMBASE and the Cochrane Library to identify studies on changes in cholesterol levels (e.g. total cholesterol, low‐density and high‐density lipoprotein cholesterol, and triglycerides) in people living with HIV who received treatment with a regimen containing tenofovir alafenamide (data collected 31 March 2023, review completed 30 July 2023). Potential risk factors for worsening lipid profile during treatment with tenofovir alafenamide were also evaluated.ResultsSixty‐five studies involving 39,713 people living with HIV were selected. Significant increases in total cholesterol, low‐density and high‐density lipoprotein cholesterol, and triglycerides were observed after treatment with tenofovir alafenamide. Specifically, low‐density lipoprotein cholesterol (+12.31 mg/dl) and total cholesterol (+18.86 mg/dl) increased markedly from the third month of tenofovir alafenamide use, with significant elevations observed across all time points up to 36 months. Comparatively, tenofovir alafenamide regimens resulted in higher lipid levels than tenofovir disoproxil fumarate regimens at 12 months of use. Notably, discontinuation of the tenofovir alafenamide regimen led to significant decreases in low‐density lipoprotein cholesterol (–9.31 mg/dl) and total cholesterol (–8.91 mg/dl). Additionally, tenofovir alafenamide use was associated with increased bodyweight (+1.38 kg; 95% confidence interval: 0.92–1.84), which became more pronounced over time. Meta‐regression analysis identified young age, male sex and low body mass index as risk factors for worsening cholesterol levels in individuals treated with tenofovir alafenamide.ConclusionsTenofovir alafenamide use in people living with HIV is associated with significant alterations in lipid profile.

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Randomized study evaluating the efficacy and safety of switching from an an abacavir/lamivudine-based regimen to an elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide single-tablet regimen

Cited by 8 publications

References 53 publications

Safety and efficacy of switching to elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate in treatment-experienced people with HIV: a multicenter cohort study

Safety and efficacy of switching to elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate in treatment-experienced people with HIV: a multicenter cohort study

Advantages of switching to elvitegravir/cobicistat/emtricitabine/tenofovir therapy in virologically-suppressed people living with human immunodeficiency virus/acquired immune deficiency syndrome

Risk of dyslipidaemia in people living with HIV who are taking tenofovir alafenamide: a systematic review and meta‐analysis

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