Tenofovir Disoproxil Fumarate, Emtricitabine, and Efavirenz Versus Fixed-Dose Zidovudine/Lamivudine and Efavirenz in Antiretroviral-Naive Patients

Pozniak, Anton; Gallant, Joel E.; DeJesus, Edwin; Arribas, José Ramón; Gazzard, Brian; Campo, Rafael; Chen, Shan Shan; McColl, Damian J.; Enejosa, Jeffrey; Toole, John J.; Cheng, Andrew

doi:10.1097/01.qai.0000245886.51262.67

Cited by 209 publications

(152 citation statements)

References 15 publications

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“…Six efficacious ART regimens, each with decreasing efficacy, are specified in the model. 27–34 All patients also face a risk of non-HIV-related mortality that depends on age and sex, 35 adjusted for race/ethnicity and other risk factors as has been previously described. 35–37 Cost of HIV treatment and care is from the health system perspective and is derived from HIV Research Network data and Medicare fee schedules.…”

Section: Methodsmentioning

confidence: 98%

“…26 Once initiated on ART, patients have a probability of virologic suppression and subsequent CD4 count gain that is specified based on current literature and divided into 3 time periods, with the greatest benefit occurring in the first 2 months on ART. 27 CD4 count gains are associated with reductions in the risk of developing opportunistic infections and of HIV-related death that also depend on prior history of opportunistic infections and ART treatment status. Upon virologic rebound, patients are switched to the next available ART regimen.…”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Cost-effectiveness of Adding an Agent That Improves Immune Responses to Initial Antiretroviral Therapy (ART) in HIV-Infected Patients: Guidance for Drug Development

Morris¹,

Scott²,

Wilkin³

et al. 2012

HIV Clinical Trials

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Purpose Adding an immune-enhancing agent to initial antiretroviral therapy (ART) for HIV is a potential strategy to ensure that patients achieve optimal immune response. Method Using a mathematical model of HIV disease and treatment, we evaluated the treatment benefits and cost-effectiveness of adding a hypothetical immune-enhancing agent to the initial 6 months of ART. We assumed that the additional agent would result in a higher CD4 increase that would provide clinical benefit. The additional cost ($1,900/month) was based on the cost of a drug currently under investigation for immune enhancement. Outcomes included projected life expectancy and cost-effectiveness in 2009 US dollars/quality-adjusted life year (QALY) with costs and QALYs discounted at 3% annually. Results Compared to standard ART, immune-enhanced ART resulting in an additional 40 CD4 cell/μL increase at 6 months yields a 2.4 month projected undiscounted life expectancy increase with a cost-effectiveness ratio of $107,600/QALY. Achieving a cost-effectiveness ratio <$100,000/QALY requires a >43 CD4 cell/μL improvement, or >19 cells/μL if immune-enhancing agent costs are halved. Conclusions In addition to showing clinical efficacy, investigational immune enhancement agents need to increase CD4 counts more than has been previously observed or have a lower cost to be considered cost-effective in the United States.

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Section: Methodsmentioning

confidence: 98%

Section: Methodsmentioning

confidence: 99%

Cost-effectiveness of Adding an Agent That Improves Immune Responses to Initial Antiretroviral Therapy (ART) in HIV-Infected Patients: Guidance for Drug Development

Morris¹,

Scott²,

Wilkin³

et al. 2012

HIV Clinical Trials

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show abstract

“…Some clinical studies have found that the dose-skipping frequency increases with the increasing number of daily medicines (17)(18)(19)(20)(21)(22). In such cases, treatment success depends on completely regular medication use.…”

Section: Discussionmentioning

confidence: 99%

The Effect of the Different Treatment Protocols on Virological and Immunological Responses in Patients with HIV/AIDS

Sari¹,

Fincancı²,

Soysal³

2014

Jpn J Infect Dis

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SUMMARY: This study analyzed the differences between the virological and immunological responses in patients with HIV/AIDS subjected to different treatment protocols. The cases treated with HAART were divided into groups on the basis of treatment protocols. The groups were evaluated with respect to the differences by comparing the virological and immunological responses prior to treatment and at 12 and 24 weeks of therapy. Six different treatment protocols were applied in the treated patients. As the largest clusters, the lopinavir/ritonavir-based patient group (Group 1, n ＝ 29) and efavirenz-based patient group (Group 2, n ＝ 18) were compared. The mean CD 4 and HIV-RNA values of Groups 1 and 2 were 184 and 243 h/ml and 422,266 and 317,684 copies/ml, respectively. At 24 weeks of treatment, the HIV-RNA levels were below detectable values in 86z and 78z of the patients in Groups 1 and 2, respectively ( p À 0.001). The striking outcomes observed in this study demonstrated that the pretreatment HIV-RNA level, CD 4 value, gender, age, and protease inhibitor-or non-nucleoside reverse transcriptase inhibitor-based combined treatment protocols do not cause a significant difference and that patient compliance to treatment is the most important factor associated with treatment success.

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“…The choice of whether to use an NNRTI, a boosted PI, or an INSTI as part of initial therapy needs to be individualized, based on issues including co-morbid conditions, likely adherence, dosing requirements, and pregnancy potential. A combination of tenofovir and emtricitabine has become the most commonly used dual-NRTI backbone in the developed world because of superior virologic outcomes, reduced drug resistance, and less toxicity than other NRTI regimens (13,60,64). Combination therapy without a dual-nucleoside backbone is not generally recommended for initial antiretroviral therapy, though several "nucleoside-sparing" regimens are under study.…”

Section: What Regimen To Begin?mentioning

confidence: 99%

Antiretroviral Therapy in the Clinic

Tsibris

Hirsch

2010

J Virol

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Currently, over 25 antiretroviral drugs and several fixed-dose drug combinations are available in most developed countries. Individual agents target many of the critical steps in the HIV replication cycle-entry, reverse transcription, integration, and proteolytic processing. Newer regimens offer greater convenience and less toxicity than ones previously used, and emerging data suggest that antiretroviral therapy should be initiated earlier during the natural history of HIV infection than was previously recommended (54). Randomized comparative testing has demonstrated superior clinical, immunologic, and virologic outcomes with certain drug combinations, although the use of certain otherwise effective antiretroviral regimens may sometimes be limited by co-morbid illnesses and toxicities. This review focuses on the translation of insights gleaned from both bench and clinical research into the day-to-day care of HIV-infected patients. We discuss the practical issues of how to choose an antiretroviral regimen, when to start therapy, how to monitor the clinical response, and how to adjust therapy for treatment failure or drug-associated toxicities.

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Tenofovir Disoproxil Fumarate, Emtricitabine, and Efavirenz Versus Fixed-Dose Zidovudine/Lamivudine and Efavirenz in Antiretroviral-Naive Patients

Abstract: Over 96 weeks, the combination of TDF, FTC, and EFV was superior to fixed-dose ZDV/3TC + EFV for achieving and maintaining an HIV RNA level <400 copies/mL and an increase in CD4 cells.

Cited by 209 publications

References 15 publications

Cost-effectiveness of Adding an Agent That Improves Immune Responses to Initial Antiretroviral Therapy (ART) in HIV-Infected Patients: Guidance for Drug Development

Cost-effectiveness of Adding an Agent That Improves Immune Responses to Initial Antiretroviral Therapy (ART) in HIV-Infected Patients: Guidance for Drug Development

The Effect of the Different Treatment Protocols on Virological and Immunological Responses in Patients with HIV/AIDS

Antiretroviral Therapy in the Clinic

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