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1.  Intrapartum Tenofovir and Emtricitabine Reduces Low-Concentration Drug Resistance Selected by Single-Dose Nevirapine for Perinatal HIV Prevention 
AIDS Research and Human Retroviruses  2009;25(11):1099-1106.
Abstract
A single dose of tenofovir/emtricitabine (TDF/FTC) during labor significantly reduces peripartum nevirapine-associated viral drug resistance when measured by consensus HIV sequencing. It is unknown whether this effect extends to HIV subpopulations of <25–50%. We conducted a randomized trial of single-dose TDF/FTC added to peripartum nevirapine to reduce drug resistance associated with nonnucleoside reverse transcriptase inhibitors (NNRTIs). To detect mutations for NNRTIs comprising ≥2% of the viral population, we used an oligonucleotide ligation assay (OLA) at codons 103, 106, 181, and 190 of HIV reverse transcriptase. To assess development of drug resistance mutations to our study intervention, OLA was also performed at codons 65 and 184. Among the 328 women included in the 2-week analysis, those receiving TDF/FTC were less likely to have NNRTI resistance by OLA (RR = 0.40, 95% CI = 0.21–0.77). A similar trend was observed among the 315 women included in the 6-week analysis (RR = 0.45, 95% CI = 0.31–0.66). Only two (1%) specimens had detectable K65R by OLA. Both were at 6 weeks postpartum; one was detected in the intervention arm and one in the control arm (p = 0.96). M184V was not detected. The ability of single-dose TDF/FTC to protect against peripartum NVP-induced NNRTI resistance extends to minority populations. This efficacy is achieved without significant selection of TDF- or FTC-resistant viruses.
doi:10.1089/aid.2009.0088
PMCID: PMC2828257  PMID: 19886836
2.  Simple Adherence Assessments to Predict Virologic Failure among HIV-Infected Adults with Discordant Immunologic and Clinical Responses to Antiretroviral Therapy 
AIDS research and human retroviruses  2008;24(8):1031-1035.
We evaluated the association between two antiretroviral therapy (ART) adherence measurements—the medication possession ratio (MPR) and patient self-report—and detectable HIV viremia in the setting of rapid service scale-up in Lusaka, Zambia. Drug adherence and outcomes were assessed in a subset of patients suspected of treatment failure based on discordant clinical and immunologic responses to ART. A total of 913 patients were included in this analysis, with a median time of 744 days (Q1, Q3: 511, 919 days) from ART initiation to viral load (VL) measurement. On aggregate over the period of follow-up, 531 (58%) had optimal adherence (MPR ≥95%), 306 (34%) had suboptimal adherence (MPR 80–94%), and 76 (8%) had poor adherence (MPR <80%). Of the 913 patients, 238 (26%) had VL ≥400 copies/ml when tested. When compared to individuals with optimal adherence, there was increasing risk for virologic failure in those with suboptimal adherence [adjusted relative risk (ARR): 1.3; 95% confidence interval (CI): 1.0, 1.6] and those with poor adherence (ARR: 1.7; 95% CI: 1.3, 2.4) based on MPR. During the antiretroviral treatment course, 676 patients (74%) reported no missed doses. The proportion of patients with virologic failure did not differ significantly among those reporting any missed dose from those reporting perfect adherence (26% vs. 26%, p = 0.97). Among patients with suspected treatment failure, a lower MPR was associated with higher rates of detectable viremia. However, the suboptimal sensitivity and specificity of MPR limit its utility as a sole predictor of virologic failure.
doi:10.1089/aid.2008.0035
PMCID: PMC2747786  PMID: 18724803
3.  Simple Adherence Assessments to Predict Virologic Failure among HIV-Infected Adults with Discordant Immunologic and Clinical Responses to Antiretroviral Therapy 
AIDS Research and Human Retroviruses  2008;24(8):1031-1035.
Abstract
We evaluated the association between two antiretroviral therapy (ART) adherence measurements—the medication possession ratio (MPR) and patient self-report—and detectable HIV viremia in the setting of rapid service scale-up in Lusaka, Zambia. Drug adherence and outcomes were assessed in a subset of patients suspected of treatment failure based on discordant clinical and immunologic responses to ART. A total of 913 patients were included in this analysis, with a median time of 744 days (Q1, Q3: 511, 919 days) from ART initiation to viral load (VL) measurement. On aggregate over the period of follow-up, 531 (58%) had optimal adherence (MPR ≥95%), 306 (34%) had suboptimal adherence (MPR 80–94%), and 76 (8%) had poor adherence (MPR <80%). Of the 913 patients, 238 (26%) had VL ≥400 copies/ml when tested. When compared to individuals with optimal adherence, there was increasing risk for virologic failure in those with suboptimal adherence [adjusted relative risk (ARR): 1.3; 95% confidence interval (CI): 1.0, 1.6] and those with poor adherence (ARR: 1.7; 95% CI: 1.3, 2.4) based on MPR. During the antiretroviral treatment course, 676 patients (74%) reported no missed doses. The proportion of patients with virologic failure did not differ significantly among those reporting any missed dose from those reporting perfect adherence (26% vs. 26%, p = 0.97). Among patients with suspected treatment failure, a lower MPR was associated with higher rates of detectable viremia. However, the suboptimal sensitivity and specificity of MPR limit its utility as a sole predictor of virologic failure.
doi:10.1089/aid.2008.0035
PMCID: PMC2747786  PMID: 18724803

Results 1-3 (3)