Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1 (THRIVE): a phase 3, randomised, non-inferiority trial

Cohen, Calvin; Andrade-Villanueva, Jaime; Clotet, Bonaventura; Fourie, Jan; Johnson, Margaret; Ruxrungtham, Kiat; Wu, Hao; Zorrilla, Carmen; Crauwels, Herta; Rimsky, L; Vanveggel, Simon; Boven, Katia

doi:10.1016/s0140-6736(11)60983-5

Cited by 329 publications

(363 citation statements)

References 23 publications

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“…Compared with efavirenz, rilpivirine led to minimal changes in LDL-C, HDL-C, TC, and triglycerides in 2 recently reported trials. 22,23 Similar observations were reported when etravirine was compared with efavirenz in the Study of Etravirine Neuropsychiatric Symptoms Versus Efavirenz Trial. 24 In the etravirine group, TC, HDL-C, and LDL-C increased by 0.40 mmol/L, 0.10 mmol/L, and 0.20 mmol/L, respectively.…”

Section: Hiv and Cholesterolsupporting

confidence: 59%

Use of HMG-CoA Reductase Inhibitors in the HIV Population: Implications for Individualized Treatment Selection

Advani

Patel²,

Pichardo³

et al. 2014

JMCP

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Section: Hiv and Cholesterolsupporting

confidence: 59%

Use of HMG-CoA Reductase Inhibitors in the HIV Population: Implications for Individualized Treatment Selection

Advani

Patel²,

Pichardo³

et al. 2014

JMCP

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“…More than 80% of viruses resistant to efavirenz or nevirapine were also resistant to rilpivirine. This suggests that care should be taken when using rilpivirine to treat HIV-1 infection, even in treatment-naive patients, 10 because of the high prevalence (2.8%) of transmitted NNRTI-resistant viruses. 11 Resistance to raltegravir was only analysed in patients taking raltegravir at the time of sampling, and was found in 66% of cases, in keeping with data from the ANRS Aquitaine CO3 Cohort.…”

Section: Discussionmentioning

confidence: 99%

Prevalence of HIV-1 drug resistance in treated patients with viral load >50 copies/mL: a 2014 French nationwide study

Assoumou

Charpentier

Recordon-Pinson

et al. 2017

Journal of Antimicrobial Chemotherapy

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Background: Surveillance of HIV-1 drug resistance in treated patients with plasma viral load (VL) .50 copies/ mL. Methods:The protease and reverse transcriptase (RT) genes were systematically sequenced in samples from 756 patients with VL .50 copies/mL in 2009. The genotyping results were interpreted for each antiretroviral drug (ARV) by using the ANRS algorithm v21. Weighted analyses were used to derive representative estimates of percentages of patients. Prevalence rates were compared with those obtained in 2004 among patients with VL .1000 copies/mL.Results: Sequences were obtained for 506 patients. Sequencing was successful in 45%, 80% and 96% of samples with VL of 51 -500, 501-1000 and .1000 copies/mL, respectively. Resistance or possible resistance to at least one ARV was observed in 59% of samples. Overall, 0.9% of samples contained viruses resistant to all drugs belonging to at least three drug classes. All resistance prevalence rates were significantly lower in 2009 than in 2004. Conclusion:In France, where 86% of patients were receiving combination antiretroviral therapy in 2009, only 15.0% of patients had a VL .50 copies/mL, suggesting that only 8.9% of treated patients could potentially transmit resistant viruses. Only 0.08% of patients harboured viruses fully resistant to at least three antiretroviral drug classes. Further studies are needed to determine whether resistance continues to decline over time.

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“…The fixed-dose combination Atripla and the individual components have been evaluated in a number of clinical trials in comparison to alternate agents including NNRTI (nevirapine, etravirine [ETR], rilpivirine [RPV]), ritonovir-boosted protease inhibitor (PI-r) (lopinavir-ritonavir [LPV-r], atazanavir-ritonavir [ATZ-r]) integrase inhibitors (raltegravir [RAL], elvitegravir), and CCR-5 inhibitors (maraviroc). [25][26][27][28][29][30][31][32][33][34][35] In the studies to date, largely of noninferiority design, and using the primary endpoints as defined by the studies, Atripla has not been beaten for efficacy by any other agent.…”

Section: Efficacymentioning

confidence: 99%

“…137 Two Phase III clinical trials (ECHO and THRIVE) have shown the Complera combination to be noninferior to Atripla in treatmentnaïve patients with HIV-1 infection. 27,28 Patients taking RPV reported fewer neurological side effects than those taking EFV (17% vs 38%) had a better lipid profile on therapy and were less likely to discontinue the regimen due to treatment side effects (3% vs 8%). In subgroup analysis, patients in the RPV arm with a baseline viral load $ 100,000 copies/mL had a significantly higher rate of virologic failure than in the EFV arm at 48 weeks (15% vs 6%), and viral failure was associated with an increased rate of drug resistance.…”

Section: New Strsmentioning

confidence: 99%

Issues in resistance, adherence, and comparative efficacy of the single-tablet regimen combination of tenofovir, emtricitabine, and efavirenz in the management of HIV-1 infection

Rebick¹,

Walmsley²

2012

VAAT

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Abstract:Atripla is the first once-daily, single-tablet, triple-combination antiretroviral therapy. It is recommended for the initial treatment of the naïve patient with human immunodeficiency virus-1 (HIV-1) infection in all current guidelines, based on its proven efficacy in numerous head-to-head randomized clinical trials. Not only has it proven efficacy, but the fixed-dose combination, Atripla, has resulted in an improvement in adherence, quality of life, and satisfaction among naïve as well as virally suppressed patients switching from another regimen. Despite the advantages, tolerability issues can arise that are related primarily to the efavirenz component, which is known to cause central nervous side effects such as dizziness, abnormal dreams, and anxiety. Although generally self-limited, these side-effects can lead to treatment discontinuation in the short-or long-term. Based on the observation of neural tube defects in macaque models, and isolated case reports in human fetuses with first trimester exposure, it is rated as Food and Drug Administration pregnancy category D, and considered as contraindicated in the first trimester of pregnancy where alternatives are available. Given the low genetic barrier of each of the individual components, resistance remains an important issue for patients with poor adherence, but is balanced in part by the long half-life of the drugs. Transmitted resistance is described in up to 16% of newly infected patients in population surveys, and is particularly prevalent in men who have sex with men. Minority variants that may impart resistant to efavirenz are not detected with currently used HIV-1 genotype assays, but nonetheless may also be implicated in patients who fail initial treatment. Several single-tablet regimens are recently licensed or in development that will challenge Atripla as the single-tablet first-line option, but none have shown superior efficacy to date.

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Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1 (THRIVE): a phase 3, randomised, non-inferiority trial

Cited by 329 publications

References 23 publications

Use of HMG-CoA Reductase Inhibitors in the HIV Population: Implications for Individualized Treatment Selection

Use of HMG-CoA Reductase Inhibitors in the HIV Population: Implications for Individualized Treatment Selection

Prevalence of HIV-1 drug resistance in treated patients with viral load >50 copies/mL: a 2014 French nationwide study

Issues in resistance, adherence, and comparative efficacy of the single-tablet regimen combination of tenofovir, emtricitabine, and efavirenz in the management of HIV-1 infection

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