Randomised Study to Assess the Efficacy and Safety of Once-Daily Etravirine-Based Regimen as a Switching Strategy in HIV-Infected Patients Receiving a Protease Inhibitor–Containing Regimen. Etraswitch Study

Echeverría, Patricia; Bonjoch, Anna; Moltó, José; Paredes, Roger; Sirera, Guillem; Ornelas, Arelly; Pérez-Álvarez, Núria; Clotet, Bonaventura; Negredo, Eugènia

doi:10.1371/journal.pone.0084676

Cited by 11 publications

(14 citation statements)

References 25 publications

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“…In the recent years, the randomized SPIRIT study, switching from PI/r to rilpivirine (RPV) has been associated with improved lipid parameters and 10-year Framingham score [ 27 ]. In the ETRASWITCH study the switch from PI/b to ETR showed a significant reduction in total cholesterol, TGL and glycemia [ 28 ].…”

Section: Combination Antiretroviral Therapy (Cart) Switchingmentioning

confidence: 99%

Cardiovascular risk and dyslipidemia among persons living with HIV: a review

Maggi¹,

et al. 2017

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BackgroundAim of this review is to focus the attention on people living with HIV infection at risk of developing a cardiovascular event. What is or what would be the most suitable antiretroviral therapy? Which statin or fibrate to reduce the risk? How to influence behavior and lifestyles?DiscussionPrevention of cardiovascular disease (CVD) risk remains the first and essential step in a medical intervention on these patients. The lifestyle modification, including smoking cessation, increased physical activity, weight reduction, and the education on healthy dietary practices are the main instruments.Statins are the cornerstone for the treatment of hypercholesterolemia. They have been shown to slow the progression or promote regression of coronary plaque, and could also exert an anti-inflammatory and immunomodulatory effect. However the current guidelines for the use of these drugs in general population are dissimilar, with important differences between American and European ones. The debate between American and European guidelines is still open and, also considering the independent risk factor represented by HIV, specific guidelines are warranted.Ezetimibe reduces the intestinal absorption of cholesterol. It is effective alone or in combination with rosuvastatin. It does not modify plasmatic concentrations of antiretrovirals. A number of experimental new classes of drugs for the treatment of hypercholesterolemia are being studied.Fibrates represent the first choice for treatment of hypertriglyceridemia, however, the renal toxicity of fibrates and statins should be considered.Omega 3 fatty acids have a good safety profile, but their efficacy is limited. Another concern is the high dose needed. Other drugs are acipimox and tesamorelin.Current antiretroviral therapies are less toxic and more effective than regimens used in the early years. Lipodistrophy and dyslipidemia are the main causes of long-term toxicities. Not all antiretrovirals have similar toxicities. Protease Inhibitors may cause dyslipidemia and lipodystrophy, while integrase inhibitors have a minimal impact on lipids profile, and no evidence of lipodystrophy. There is still much to be written with the introduction of new drugs in clinical practice.ConclusionsCardiovascular risk among HIV infected patients, interventions on behavior and lifestyles, use of drugs to reduce the risk, and switch in antiretroviral therapy, remain nowadays major issues in the management of HIV-infected patients.

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Section: Combination Antiretroviral Therapy (Cart) Switchingmentioning

confidence: 99%

Cardiovascular risk and dyslipidemia among persons living with HIV: a review

Maggi¹,

et al. 2017

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“…(24–26) A similar increase in HDL-C was seen in a study in which virologically suppressed patients were switched from NRTI- and PI-based therapy to ETR, but this has not been consistently observed in other studies of ETR. (7, 19, 22) Analysis of fasting insulin and glucose levels in our study showed a modest increase in HOMA-IR but no change in glycemia compared to baseline. Our study is the first to assess body fat distribution by DEXA scan in patients initiating therapy with ETR, and found that total body fat, as well as truncal and limb fat, remained stable after 24 weeks on ETR.…”

Section: Discussionmentioning

confidence: 47%

Section: Discussionmentioning

confidence: 99%

“…(4, 19–22) In several prior studies in which virologically suppressed patients switched from protease inhibitor (PI) and efavirenz-based therapy to ETR-based ARV, significant improvement in the lipid profile, and in some studies glycemic control, was observed after switching. (19–23) Notably, participants in our study did experience an increase in HDL-C, an improvement that has been reported with the NNRTIs nevirapine and efavirenz. (24–26) A similar increase in HDL-C was seen in a study in which virologically suppressed patients were switched from NRTI- and PI-based therapy to ETR, but this has not been consistently observed in other studies of ETR.…”

Section: Discussionmentioning

confidence: 99%

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Antiretroviral Activity and Safety of Once-Daily Etravirine in Treatment-Naive HIV-Infected Adults: 48-Week Results

et al. 2016

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Background Etravirine (ETR), an NNRTI approved for 200 mg BID dosing in conjunction with other antiretrovirals (ARVs), has pharmacokinetic properties which support once-daily dosing. Methods In this single arm, open-label study, 79 treatment-naïve HIV-infected adults were assigned to receive ETR 400 mg plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) 300/200mg once daily to assess antiviral activity, safety, and tolerability. Antiretroviral activity at 48 weeks was determined by proportion of subjects with HIV-1 RNA <50 copies/mL (intention-to-treat, missing = failure). Results Of 79 eligible subjects, 90% were men, 62% African-American and 29% Caucasian. At baseline, median (Q1, Q3) age was 29 years (23, 44) and HIV-1 RNA 4.52 log10 copies/mL (4.07, 5.04). Sixty-nine (87%) completed a week 48 visit and 61 (77%, 95% CI: 66 – 86%) achieved HIV-1 RNA <50 copies/mL at week 48. At time of virologic failure, genotypic resistance-associated mutations were detected in 3 participants, 2 with E138K (1 alone and 1 with additional mutations). Median (95% CI) CD4+ cell count increase was 163 (136, 203) cells/uL. Fifteen (19.0%) participants reported a new sign/symptom or lab abnormality ≥ Grade 3 and 3 participants (3.8 %) permanently discontinued ETR due to toxicity. Two participants had psychiatric symptoms of any grade. There were no deaths. Conclusions In this study of ARV-naïve HIV+ adults, once daily ETR with TDF/FTC had acceptable antiviral activity and was well-tolerated. Once daily ETR may be a plausible option as part of a combination ARV regimen for treatment-naïve individuals.

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“…The study has a short follow-up period, which does not allow evaluation of the long-term effect of the proposed treatment strategy, but in a previously reported clinical trial, the effect of switch to ETR on lipid profile could be maintained over the follow-up period of 48 weeks [34]. We did not collect information on nutrition or physical activities, which may have contributed to the lipid changes over the study period.…”

Section: Discussionmentioning

confidence: 99%