Efavirenz versus Boosted Atazanavir or Zidovudine and Abacavir in Antiretroviral Treatment–Naive, HIV‐Infected Subjects: Week 48 Data from the Altair Study

Puls, Rebekah; Srasuebkul, Preeyaporn; Petoumenos, Kathy; Boesecke, Christoph; Duncombe, Chris; Belloso, Waldo; Molina, Jean‐Michel; Li, Lin; Avihingsanon, Anchalee; Gazzard, Brian; Cooper, David A.; Emery, Sean

doi:10.1086/656363

Cited by 58 publications

(57 citation statements)

References 32 publications

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“…18 Conversely, other randomized controlled studies such as the ACTG A5202 study or the Altair study have demonstrated equivalent efficacy with efavirenz-versus boosted atazanavir-based regimens. 19,20 However, these studies excluded patients with known baseline NNRTI resistance and thus cannot specifically address the issue. A subanalysis of A5202 comparing the efficacy of efavirenz and boosted atazanavir between different males and females showed the inferiority of boosted atazanavir in in black race and females.…”

mentioning

confidence: 99%

Transmitted Drug-Resistant HIV Type 1 Remains Prevalent and Impacts Virologic Outcomes Despite Genotype-Guided Antiretroviral Therapy

Taniguchi

Nurutdinova²,

Grubb³

et al. 2012

AIDS Research and Human Retroviruses

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Trends in transmitted drug resistance-associated mutations (TDRM) in HIV-1infection vary depending on geographic and cohort characteristics. The impact of TDRM among patients receiving fully active combination antiretroviral therapy (cART) is poorly characterized. This was a retrospective study of 801 HIV-1-infected treatment-naive patients from 2001 to 2009 who had pre-cART genotype resistance test results available. The prevalence of TDRM was compared for each year strata. Multivariate Cox proportional hazards regression models were used to assess factors associated with virologic failure at 48 weeks. TDRM was detected in 136 (17%) patients with ‡ 2 class TDRM in 20 patients. K103N/S was the most frequent (n = 77). There were no changes in the prevalence of mutations over time (P trend = 0.67). Six hundred and eleven patients were started on cART. Virologic failure occurred in 38% of those with TDRM and 24% of those without ( p < 0.01). In multivariate analysis, nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance was associated with a 1.5-fold increased risk of virologic failure. TDRM remains common among treatment-naive HIV-1-infected patients, affecting one in six patients. Transmission of NNRTI drug resistance was associated with risk of virologic failure despite initiation of genotype-guided cART.

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confidence: 99%

Transmitted Drug-Resistant HIV Type 1 Remains Prevalent and Impacts Virologic Outcomes Despite Genotype-Guided Antiretroviral Therapy

Taniguchi

Nurutdinova²,

Grubb³

et al. 2012

AIDS Research and Human Retroviruses

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“…Consistent with the trend towards earlier initiation of ART, the median baseline CD4 cell count at which patients start ART has risen in the past decade in all regions; however, the proportion of people initiating ART with very low CD4 counts remains high, with more than one in four patients starting ART at CD4 count 100 cells per μL or less across all regions. 32 Patients presenting with a low CD4 cell count are at increased risk of death in both low and high-income settings, 33,34 and determination of CD4 count has an important role in decisions for screening and prophylaxis for major opportunistic infections. A low CD4 count is predictive of several diseases associated with increased mortality, including cryptococcal meningitis, pneumocystis pneumonia, toxoplasmosis, Mycobacterium avium complex, and disseminated cytomegalovirus disease.…”

Section: 28mentioning

confidence: 99%

The future role of CD4 cell count for monitoring antiretroviral therapy

Ford

Meintjes

Pozniak

et al. 2015

The Lancet Infectious Diseases

123

100

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For more than two decades, CD4 cell count measurements have been central to understanding HIV disease progression, making important clinical decisions, and monitoring the response to antiretroviral therapy (ART). In well resourced settings, the monitoring of patients on ART has been supported by routine virological monitoring. Viral load monitoring was recommended by WHO in 2013 guidelines as the preferred way to monitor people on ART, and efforts are underway to scale up access in resource-limited settings. Recent studies suggest that in situations where viral load is available and patients are virologically suppressed, long-term CD4 monitoring adds little value and stopping CD4 monitoring will have major cost savings. CD4 cell counts will continue to play an important part in initial decisions around ART initiation and clinical management, particularly for patients presenting late to care, and for treatment monitoring where viral load monitoring is restricted. However, in settings where both CD4 cell counts and viral load testing are routinely available, countries should consider reducing the frequency of CD4 cell counts or not doing routine CD4 monitoring for patients who are stable on ART

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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%

“…29 When comparing groups in a higher virologic strata (HIV-1 viral load $ 100,000 copies/mL), patients taking ABC-3TC combined with boosted-ATZ had higher rates of virologic failure than those taking ABC-3TC combined with EFV (HR, 1.68; 95% CI: 1.08 to 2.60; P = 0.019). 37 The Altair study found that a quadruple NRTI regimen (TDF-FTC-ZDV-ABC) was inferior to TDF-FTC-EFV, mostly due to therapy discontinuations from adverse events in the ITT analysis, although there was no difference of the latter to TDF-FTC-ATZ-r. 30 The STARTMRK study was the first study comparing TDF-FTC-EFV to an integrase inhibitor-based regimen. 566 treatment-naïve patients were randomized to Truvada (TDF-FTC) plus either EFV or RAL.…”

Section: Efficacymentioning

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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Efavirenz versus Boosted Atazanavir or Zidovudine and Abacavir in Antiretroviral Treatment–Naive, HIV‐Infected Subjects: Week 48 Data from the Altair Study

Cited by 58 publications

References 32 publications

Transmitted Drug-Resistant HIV Type 1 Remains Prevalent and Impacts Virologic Outcomes Despite Genotype-Guided Antiretroviral Therapy

Transmitted Drug-Resistant HIV Type 1 Remains Prevalent and Impacts Virologic Outcomes Despite Genotype-Guided Antiretroviral Therapy

The future role of CD4 cell count for monitoring antiretroviral therapy

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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