Induction With Abacavir/Lamivudine/Zidovudine Plus Efavirenz for 48 Weeks Followed by 48-Week Maintenance With Abacavir/Lamivudine/Zidovudine Alone in Antiretroviral-Naive HIV-1-Infected Patients

Markowitz, Martin; Hill-Zabala, Christina; Lang, Joseph; DeJesus, Edwin; Liao, Qiming; Lanier, E. Randall; Davis, Elizabeth B.; Shaefer, Mark S.

doi:10.1097/01.qai.0000169664.15536.20

Cited by 43 publications

(30 citation statements)

References 24 publications

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“…Several drug guides suggest that there have been post-marketing reports of patients committing suicide, but this issue does not come up on the U.S. Food and Drug Administration MedWatch site for post-marketing surveillance, so it is unclear if the suicidality was related to efavirenz [17,18]. None of the larger RCTs that report neuropsychiatric side effects as secondary measures note suicides of patients on efavirenz, although those trials tended to be shorter in duration [15,19]. The trials on which the SustivaÓ package insert is Brokaw et al [51] Patients initiated on EFV were followed for 6 months.…”

Section: Violence/suicide Riskmentioning

confidence: 96%

A Systematic Review of the Psychiatric Side-Effects of Efavirenz

2011

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Concerns regarding the use of efavirenz in patients with a history of mental illness may predispose clinicians to not offer this agent to psychiatrically ill populations in spite of the convenience of once daily dosing, which can result in improved adherence in these at-risk populations. This systematic review examines the current data regarding the neuropsychiatric effects of efavirenz, and also attempts to provide guidance to clinicians using efavirenz to treat patients with mental illness. The review identified high rates of neuropsychiatric side effects including vivid dreams, insomnia and mood changes in approximately 50% of patients who initiate efavirenz. The effects begin quickly, commonly peak in the first 2 weeks, and are generally mild and transient in nature. Isolated case reports and uncontrolled data suggest higher rates of severe side effects; however, there is no clear evidence of a broadly increased risk of suicide or dangerous behavior for patients taking efavirenz as part of their antiretroviral regimen.

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Section: Violence/suicide Riskmentioning

confidence: 96%

A Systematic Review of the Psychiatric Side-Effects of Efavirenz

2011

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“…17,21,[23][24][25][26][27] Subsequent studies exploring the induction-maintenance concept in ART-naïve patients showed similar virologic success (i.e., noninferiority) for triple NRTI regimens compared to two-class cART. 16,21,22,[28][29][30][31] However, some of these studies were not entirely prospective, 16,21,29 or did not have a comparative design for the maintenance phase, 28,30 or used poorly tolerated quadruple regimens as induction regimens. 22,32 Here we describe a randomized, prospective study in ARTnaïve patients using a standard triple cART as induction therapy, followed by maintenance with TZV in those who reached an undetectable plasma viral load (less than 50 copies per milliliter).…”

Section: (Panel On Antiretroviral Guidelines For Adult Andmentioning

confidence: 97%

“…21 Compared to continued quadruple NNRTI-based treatment, adherence to triple NRTI maintenance therapy was better. 22 Earlier studies addressing a switch to triple NRTI included patients who had not been ART-naïve from the start, resulting in suboptimal responses. 17,21,[23][24][25][26][27] Subsequent studies exploring the induction-maintenance concept in ART-naïve patients showed similar virologic success (i.e., noninferiority) for triple NRTI regimens compared to two-class cART.…”

Section: (Panel On Antiretroviral Guidelines For Adult Andmentioning

confidence: 99%

Abacavir/Lamivudine/Zidovudine Maintenance After Standard Induction in Antiretroviral Therapy-Naïve Patients: FREE Randomized Trial Interim Results

Sprenger

Langebeek

Mulder

et al. 2010

AIDS Patient Care and STDs

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Maintenance with a triple nucleoside reverse transcriptase Inhibitor (NRTI) regimen after successful induction with a dual NRTI/protease inhibitor (PI) combination may be advantageous, because of low pill burden, favorable lipids, and less drug interactions. This strategy to become free of PI-related problems without losing viral efficacy has not been formally tested. We performed a randomized, open-label, multicenter, 96-week comparative study in antiretroviral therapy (ART)-naïve patients with CD4 50 copies per milliliter). Two hundred seven patients had similar baseline (BL) characteristics: median CD4 180 cells/mm(3), median VL 5.19 log(10) copies per milliliter. One hundred twenty subjects (58%) met randomization criteria. Baseline VL differed significantly between dropouts and randomized subjects (median 5.41 versus 5.06 log(10) copies per milliliter, p = 0.017), as did CD4 cells (median 160 and 200 cells/mm(3), p = 0.044). Sixty-one subjects received TZV and 59 subjects continued NRTIs/PI. At week 48, 2 patients in the TZV group and 5 in the PI group did not have a sustained virologic suppression (log rank test; p = 0.379). CD4 counts increased significantly in both arms. In ART-naïve patients, TZV maintenance had similar antiviral efficacy compared to continued standard ART at 48 weeks after baseline. Patients on successful standard ART can be safely switched to a NRTI-only regimen, at least for the tested time period.

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“…'I'his strategy is called induction-maintenance and is based on the assumption that after a phase of maximal suppressive HAAR'f (induction), the same level of viral suppression could be maintained by fewer drugs (maintenance). -frials using NRTIs and/or a Íìrst-generation PI as mainrenance therapv have produced variable findings [53][54][55][56][57][58], but PI/r monotherapy maintenance has also been studied in the past few years. Advantages of this approach would be reduction of side effects (including avoidance of long-term NRTI toxicity) ancl fewer drug inreracrions and costs.…”

Section: Overview Of New Arvs Under Investigationmentioning

confidence: 99%

Recent advances in antiretroviral treatment and prevention in HIV-infected patients

Maltêz

Doroana

Branco

et al. 2011

Current Opinion in HIV and AIDS

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CuÌÌent Opinion in HIV and AIDS 201 1, 6 (suppl l):521 -S30 IntroductionMore than 25 years after the identification of HIV as rhe causative agent of AIDS, the disease continues to spread in some countries [1]. Current antiretrovirals (ARVs) have significantly prolonged the time to both AIDS development and death in those infecced with HIV [2], although ARV success has ultimately been limited by toxicity, drug-drug interactions and other factors that determine patient compliance and, consequently, the emergence of resistance. Thus, there is a continuous need for existing agents to be improved and for the development of new drugs and drug classes that are effective, safe, have a higher genetic barrier to resistance. penetrare viral reservoirs more effectively and have activity against resisrant viruses. Another challenge is to develop strategies that maximize the efficacy of currently available drugs for as long as possible; how to start, when to start, how to change and when to change ARV therapy (ART) are all crucial elements of this strategy. However, it should be noted that access to new drugs and strategies serves no purpose if the chain of new infections is not broken and if the low levels of prevention and education that are currently in place persist. Unfortunately, relative to the advances 1746-630X O 2011 Wolters Kluwer Health I Lìppincott Williams & WilkinsPurpose of review To discuss new antiretroviral agents (ARVs) and alternative ARV treatment strategies that are currently being evaluated, and to provide an overview oÍ the most recent advances in HIV vaccine development. Recent findings There is a continuous need for improvements in ARV therapy (ART) and several new ARVs are currently undergoing clinical investigatìon, including the non-nucleoside reverse transcriptase inhibitor rilpivirine, the integrase inhibitor elvitegravir, the chemokine receptor 5 co-receptor antagonist vicriviroc and the maturation inhibitor bevirimat. Strategies to optimize ART, such as treatment interruption, inductionmaintenance and class-sparing regimens, are also being evaluated and have had varying success to date. However, vaccination still remains the optimal solution, and one second-generation preventative HIV vaccine has produced encouraging results in a recent phase lll tria!. SummaryGlobal prevention and treatment with ARVs that are effective, well tolerated and have high barriers to the development of HIV resistance are the main strategies to fight HIV/ AIDS while we await the develooment of an effective vaccine.

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Induction With Abacavir/Lamivudine/Zidovudine Plus Efavirenz for 48 Weeks Followed by 48-Week Maintenance With Abacavir/Lamivudine/Zidovudine Alone in Antiretroviral-Naive HIV-1-Infected Patients

Abstract: After induction with ABC/3TC/ZDV+EFV, simplification to ABC/3TC/ZDV alone maintained virologic control and immunologic response, reduced fasting lipids and ART-associated adverse events, and improved adherence.

Cited by 43 publications

References 24 publications

A Systematic Review of the Psychiatric Side-Effects of Efavirenz

A Systematic Review of the Psychiatric Side-Effects of Efavirenz

Abacavir/Lamivudine/Zidovudine Maintenance After Standard Induction in Antiretroviral Therapy-Naïve Patients: FREE Randomized Trial Interim Results

Recent advances in antiretroviral treatment and prevention in HIV-infected patients

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