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A Clinical Prediction Score in Addition to WHO Criteria for Anti-Retroviral Treatment Failure in Resource-Limited Settings - Experience from Lesotho.
PLoS ONE. 2012 Oct 31; 7(10):e47937.Objective: To assess the positive predictive value (PPV) of a clinical score for viral failure among patients fulfilling the WHO-criteria for anti-retroviral treatment (ART) failure in rural Lesotho. Methods: Patients fulfilling clinical and/or immunological WHO failure-criteria were enrolled. The score includes the following predictors: Prior ART exposure (1 point), CD4-count below baseline (1), 25% and 50% drop from peak CD4-count (1 and 2), hemoglobin drop=1 g/dL (1), CD4 count<100/µl after 12 months (1), new onset papular pruritic eruption (1), and adherence<95% (3). A nurse assessed the score the day blood was drawn for viral load (VL). Reported confidence intervals (CI) were calculated using Wilsons method. Results: Among 1'131 patients on ART=6 months, 134 (11.8%) had immunological and/or clinical failure, 104 (78%) had blood drawn (13 died, 10 lost to follow-up, 7 did not show up). From 92 (88%) a result could be obtained (2 samples hemolysed, 10 lost). Out of these 92 patients 47 (51%) had viral failure (=5000 copies), 27 (29%) viral suppression (<40) and 18 (20%) intermediate viremia (40-4999). Overall, 20 (22%) had a score=5. A score=5 had a PPV of 100% to detect a VL>40 copies (95%CI: 84-100), and of 90% to detect a VL=5000 copies (70-97). Within the score, adherence<95%, CD4-count<100/Âµl and papular pruritic eruption were the strongest single predictors. Among 47 patients failing, 8 (17%) died before or within 4 weeks after being switched. Overall mortality was 4 (20%) among those with score=5 and 4 (5%) if score<5 (OR 4.3; 95%CI: 0.96-18.84, p = 0.057). Conclusion: A score=5 among patients fulfilling WHO-criteria had a PPV of 100% for a detectable VL and 90% for viral failure. In settings without regular access to VL-testing, this PPV may be considered high enough to switch this patient-group to second-line treatment without confirmatory VL-test.
The Spectrum projection package: improvements in estimating mortality, ART needs, PMTCT impact and uncertainty bounds.
Sexually Transmitted Infections. 2008; 84(Suppl 1):i24-i30.The approach to national and global estimates of HIV/AIDS used by UNAIDS starts with estimates of adult HIV prevalence prepared from surveillance data using either the Estimation and Projection Package (EPP) or the Workbook. Time trends of prevalence are transferred to Spectrum to estimate the consequences of the HIV/AIDS epidemic, including the number of people living with HIV, new infections, AIDS deaths, AIDS orphans, treatment needs and the impact of treatment on survival. The UNAIDS Reference Group on Estimates, Modelling and Projections regularly reviews new data and information needs and recommends updates to the methodology and assumptions used in Spectrum. The latest update to Spectrum was used in the 2007 round of global estimates. Several new features have been added to Spectrum in the past two years. The structure of the population was reorganised to track populations by HIV status and treatment status. Mortality estimates were improved by the adoption of new approaches to estimating non-AIDS mortality by single age, and the use of new information on survival with HIV in non-treated cohorts and on the survival of patients on antiretroviral treatment (ART). A more detailed treatment of mother-to-child transmission of HIV now provides more prophylaxis and infant feeding options. New procedures were implemented to estimate the uncertainty around each of the key outputs. The latest update to the Spectrum program is intended to incorporate the latest research findings and provide new outputs needed by national and international planners.