Based on the aforementioned findings we surmised that the comparison of the immunologic (CD4+ T cell profiles and DTH skin test reactivity) and virologic (viral load) profiles would reveal a step-wise worsening in subjects categorized to B*57-NPD, B*57-PD and those lacking a B*57 allele.
Results and conclusions: The proportions of patients who continued the same therapeutic regimen and showed virologic success (viral load <400 copies/ml) up to 108 weeks were 78 and 63%, respectively, based on intent-to-treat analysis.
Plasma samples from 22 antiretroviral-experienced subjects collected at time of virologic failure (viral load 1380 to 304,000 copies/mL) were obtained from a specimen bank (from 2004 2007).
HIV-positive women with virologic suppression (viral load < 50copies/mL) on their first antiretroviral regimen were enrolled.
Following an initial decline of viral load, virologic failure was common at 12 and 24 months postpartum among women initiated on ART for life during pregnancy because of low CD4 cell counts.
However, considering the low virologic response (viral load 57,126 IU/mL), the patient's overall clinical status, low prothrombin index, low body mass index and significant blood count abnormalities (anemia, thrombocytopenia and neutropenia), we decided to discontinue therapy, without new lesions at follow-up.
We selected subjects enrolled in a phase IIb clinical trial of VVC who experienced protocol-defined virologic failure (<1 log10 viral load decrease at or after week 16) and a change in coreceptor usage as determined by a validated phenotypic assay (Trofile, Monogram Biosciences, South San Francisco, CA); subjects with assay-detectable CXCR4-using virus at baseline were excluded [13].
Noninferiority was defined as a 12% margin in the percentage of subjects with confirmed virologic response, ie, viral load < 50 copies/mL based on an intention-to-treat time to loss of virologic response algorithm.
The probability of virologic failure (confirmed viral load >1000 copies/mL) by 52 weeks post-randomization was similar between boys and girls who remained on LPV/r (0 vs. 0.043, p = 0.162) as well as between boys and girls who switched to nevirapine (0.224 vs. 0.172, p = 0.575).
Thus, immuno-virologic discordance occurs when viral load test results used to assess virologic failure do not correspond to expected CD4 cell count results used to assess immunologic failure, and this discordance is associated with poor clinical outcomes.
