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  • Efavirenz-Based Antiretroviral Therapy Among Nevirapine-Exposed HIV-Infected Children in South Africa: A Randomized Clinical Trial

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    JAMA. 2015; 314(17):1808-1817. doi: 10.1001/jama.2015.13631

    This randomized trial compares risks of viral rebound and viral failure with continuation of ritonavir-boosted lopinavir vs switching to efavirenz among children with human immunodeficiency virus (HIV) infection exposed to nevirapine for prevention of mother-to-child transmission who had initial viral suppression with ritonavir-boosted lopinavir–based therapy.

  • JAMA November 3, 2015

    Figure: Flow of HIV-Infected Children Randomized to Continue a Ritonavir-Boosted Lopinavir–Based Regimen or Switch to an Efavirenz-Based Regimen

    HIV indicates human immunodeficiency virus. “Transferred” indicates children whose care was transferred to other health care facilities because of relocation.aBecause of an administrative error, this patient was not switched to efavirenz and continued taking ritonavir-boosted lopinavir all the way through the study but was analyzed per intention to treat in the efavirenz group.
  • Antiretroviral Therapy for Nevirapine-Exposed Children With HIV Infection

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    JAMA. 2015; 314(17):1801-1802. doi: 10.1001/jama.2015.13763
  • Antiretroviral Treatment of Adult HIV Infection: 2014 Recommendations of the International Antiviral Society–USA Panel

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    JAMA. 2014; 312(4):410-425. doi: 10.1001/jama.2014.8722

    Günthard and coauthors report the 2014 recommendations of the International Antiviral Society–USA Panel on antiretroviral treatment of adult human immunodeficiency virus (HIV) infection.

  • Association Between Efavirenz-Based Compared With Nevirapine-Based Antiretroviral Regimens and Virological Failure in HIV-Infected Children

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    JAMA. 2013; 309(17):1803-1809. doi: 10.1001/jama.2013.3710
    Lowenthal and coauthors report on the association between efavirenz-based vs nevirapine-based antiretroviral regimens and virological failure in children infected with human immunodeficiency virus.
  • Antiretroviral Treatment of Adult HIV Infection: 2012 Recommendations of the International Antiviral Society–USA Panel

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    JAMA. 2012; 308(4):387-402. doi: 10.1001/jama.2012.7961
    Thompson and coauthors provide an update of guidelines recommended by the International Antiviral Society–USA Panel on antiretroviral therapy for HIV-infected adults in developed-world settings.
  • Outcomes of Nevirapine- and Efavirenz-Based Antiretroviral Therapy When Coadministered With Rifampicin-Based Antitubercular Therapy

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    JAMA. 2008; 300(5):530-539. doi: 10.1001/jama.300.5.530
  • Three- vs Four-Drug Antiretroviral Regimens for the Initial Treatment of HIV-1 Infection: A Randomized Controlled Trial

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    JAMA. 2006; 296(7):769-781. doi: 10.1001/jama.296.7.769
  • JAMA August 16, 2006

    Figure 1: Disposition of Patients—AIDS Clinical Trials Group Study A5095

    ABC indicates abacavir; EFV, efavirenz; 3TC, lamivudine; ZDV, zidovudine. *Details reported in Gulick et al.
  • JAMA August 16, 2006

    Figure 2: Time to First Virologic Failure (Intent-to-Treat Analysis)—3-Drug Group vs 4-Drug Group

    The 4-drug group received zidovudine/lamivudine/abacavir plus efavirenz; 3-drug group, zidovudine/lamivudine plus efavirenz. The numbers at risk over time represent the number of patients in the study without previous virologic failure (regardless of initial treatment status); patients previously discontinuing from the study prior to virologic failure are censored at the time of their last human immunodeficiency virus 1 RNA evaluation. The P values and confidence intervals presented are nominal. CI indicates confidence interval; HR, hazard ratio.
  • JAMA August 16, 2006

    Figure 5: CD4 Cell Counts (Change From Baseline) (Intent-to-Treat Analysis)—3-Drug Group vs 4-Drug Group

    The 4-drug group received zidovudine/lamivudine/abacavir plus efavirenz; 3-drug group, zidovudine/lamivudine plus efavirenz. The number of patients contributing data at each time point represents the number with a CD4 cell count evaluation for that study week (regardless of treatment status). Missing data (due to randomly missed evaluations, previous loss to follow-up, and administrative censoring) are ignored. The changes are compared using 2-sample t tests. Error bars indicate 97.5% confidence intervals. All P values and confidence intervals presented are nominal, unadjusted for multiple comparisons. Comparisons at prespecified time points were not significantly different (P>.05 for all).
  • JAMA August 16, 2006

    Figure 3: Proportion of Patients With HIV-1 RNA Level Less Than 200 and Less Than 50 Copies/mL (Intent-to-Treat Analysis)—3-Drug Group vs 4-Drug Group

    The 4-drug group received zidovudine/lamivudine/abacavir plus efavirenz; 3-drug group, zidovudine/lamivudine plus efavirenz. The number of patients contributing data at each time point (the denominator for the proportion) represents the number of patients with a human immunodeficiency virus 1 (HIV-1) RNA evaluation for that study week; the numerator for the proportion is the number of patients with HIV-1 RNA levels less than 200 or less than 50 copies/mL (regardless of treatment status). Missing data (due to randomly missed evaluations, previous loss to follow-up, and administrative censoring) are ignored. Proportions are compared at weeks 24, 48, 72, 96, and 144 using χ2 tests. Error bars indicate 97.5% confidence intervals. All P values and confidence intervals presented are nominal, unadjusted for multiple comparisons. Comparisons at prespecified time points were not significantly different (P>.05 for all).
  • JAMA August 16, 2006

    Figure 6: Proportion of Patients Who Reported Not Missing a Dose of Study Medication During the Previous 4 Days Over the Course of the Study—3-Drug Group vs 4-Drug Group

    The 4-drug group received zidovudine/lamivudine/abacavir plus efavirenz; 3-drug group, zidovudine/lamivudine plus efavirenz. The number of patients contributing data at each time point (the denominator for the proportion) represents the number of patients receiving initial treatment with an adherence evaluation for that study week; the numerator for the proportion is the number of patients reporting full adherence over the prior 4 days. Missing data (due to randomly missed evaluations, previous loss to follow-up, and administrative censoring) are ignored. Error bars indicate 97.5% confidence intervals. All P values and confidence intervals presented are nominal, unadjusted for multiple comparisons. Comparisons at prespecified time points were not significantly different (P>.05 for all).
  • JAMA August 16, 2006

    Figure 4: Proportion of Patients With HIV-1 RNA Levels Less Than 50 Copies/mL (4 Different Analyses)—3-Drug Group vs 4-Drug Group

    The 4-drug group received zidovudine/lamivudine/abacavir plus efavirenz; 3-drug group, zidovudine/lamivudine plus efavirenz. For each panel, the number of patients contributing data at each week (the denominator for the proportion) represents the number of patients: A, With a human immunodeficiency virus 1 (HIV-1) RNA evaluation for that study week while receiving initial treatment; B, With an HIV-1 RNA evaluation regardless of treatment status; and C and D, Expected to have an HIV-1 RNA evaluation based on their randomization date. The numerator for the proportion is the number of patients with: A, HIV-1 RNA levels <50 copies/mL (missing data treated as failure); B, HIV-1 RNA levels <50 copies/mL (regardless of treatment status, missing data ignored); C, HIV-1 RNA levels <50 copies/mL (regardless of treatment status, missing data treated as failure); and D, HIV-1 RNA levels <50 copies/mL (missing data treated as failure, off-initial treatment treated as failure). Error bars indicate 97.5% confidence intervals. All P values and confidence intervals presented are nominal, unadjusted for multiple comparisons. Comparisons at prespecified time points were not significantly different (P>.05 for all).
  • JAMA February 16, 2005

    Figure 1: Blips and Drug Levels

    Plasma human immunodeficiency virus 1 (HIV-1) RNA levels, plasma concentrations of protease and nonnucleoside reverse transcriptase inhibitors, and suggested minimum target trough concentration (as provided by drug manufacturers), for each of the 10 patients. Data markers below the black dotted line indicate undetectable levels of plasma HIV-1 RNA (<50 copies/mL). Patients were sampled 36 times. For each sample, viral RNA was measured in 2 independent laboratories. For each time point, the higher value was plotted. A total of 720 viral load measurements were expected (36 time points × 2 independent measurements × 10 patients). Of these, 713 were collected (99.03%). Of planned assays for plasma drug concentration, 98.33% were completed. M8 is the measurable active metabolite of nelfinavir. EFV indicates efavirenz; LPV, lopinavir; NFV, nelfinavir; NVP, nevirapine; RTV, ritonavir; SQV, saquinavir.
  • JAMA February 16, 2005

    Figure 3: Phylogenetic Tree of Reverse Transcriptase Sequences for Patient 136 and Associated Genotypes

    All reverse transcriptase (RT) sequences from patient 136 clustered together, away from the reference sequence HXB2 and representative baseline sequences from other study patients (top). Plasma sequences are coded by visit number, with groups of 5 consecutive visits represented by a single symbol. The resting cell reservoir was sampled only at baseline. The RT region could not be amplified from the plasma of patient 140 (thus, there was no need to assess cellular reservoir virus for comparison purposes). Genetic distance from the most recent common ancestor (horizontal scale) is not greater for blip sequences. The table on the right provides the genotype for each branch of the tree (which represents all 9 study patients). Amino acid positions in RT are shown at the top of the table (protease trees are less informative because the gene is smaller and more conserved [thus, these trees are not provided herein]; however, the protease trees showed no evidence for evolution during blips and no new drug resistance mutations). The sequence of the reference isolate HXB2 is indicated under the amino acid numbers. Positions associated with resistance to the drugs the patient was taking (zidovudine, lamivudine, and efavirenz) are shown in color. Representative polymorphisms (amino acid substitutions not associated with drug resistance that distinguish this patient’s virus population from other isolates) are also shown. No resistance mutations were detected in this patient. The L→M and L→V substitutions at position 210 are not associated with significant resistance to zidovudine. There were no missing data for this analysis except as indicated above. AA indicates amino acid; AZT, zidovudine; EFV, efavirenz; HIV, human immunodeficiency virus; 3TC, lamivudine.
  • JAMA February 16, 2005

    Figure 2: Lack of New Genotypic Resistance Mutations in Plasma Virus During or Immediately After Blips

    At all points other than those at which the plasma HIV-1 RNA level was ≥50 copies/mL, the viral load was undetectable. Up to 7 independent clones were obtained at each time point. Note that no new mutations conferring drug resistance appeared during the blips. All mutations detected during or within 30 days after blips were present at baseline (B) or were seen in plasma samples taken prior to the blips. Baseline mutations were identified in either plasma or resting CD4 cell reservoir samples (peripheral blood). The resting cell reservoir was sampled only at baseline. “Prior ART exposure” refers to other antiretroviral drugs the patient has taken that are not part of the current regimen. ABC indicates abacavir; ADF, adefovir; APV, amprenavir; ART, antiretroviral therapy; AZT, zidovudine; ddC, zalcitabine; ddI, didanosine; d4T, stavudine; EFV, efavirenz; HAART, highly active antiretroviral therapy; HIV, human immunodeficiency virus; IDV, indinavir; LPV, lopinavir; NFV, nelfinavir; NNRTI, nonnucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; NVP, nevirapine; PI, protease inhibitor; RTV, ritonavir; SQV, saquinavir; TDF, tenofovir disoproxil fumarate; 3TC, lamivudine; WT, wild type.
  • Efficacy and Safety of Tenofovir DF vs Stavudine in Combination Therapy in Antiretroviral-Naive Patients: A 3-Year Randomized Trial

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    JAMA. 2004; 292(2):191-201. doi: 10.1001/jama.292.2.191
  • Efficacy and Safety of Emtricitabine vs Stavudine in Combination Therapy in Antiretroviral-Naive Patients: A Randomized Trial

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    JAMA. 2004; 292(2):180-189. doi: 10.1001/jama.292.2.180
  • Treatment for Adult HIV Infection: 2004 Recommendations of the International AIDS Society-USA Panel

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    JAMA. 2004; 292(2):251-265. doi: 10.1001/jama.292.2.251