WHO/HIV/2013.42
© World Health Organization 2013
GRADE tables: How accurately do the WHO 2010 immunological and clinical criteria predict virological failure in adults on ART? Authors: George W. Rutherford, Tara Horvath
Immunologic criteria and virological failure Immunological criteria with definition of virological failure >5000 copies/ml Bibliography: Labhardt 2012; Moore 2008; Reynolds 2009 Settings: Lesotho, Uganda Comparison: WHO 2010 immunological criteria and VL >5000 copies/ml Values and uncertainty Number of participants around these (studies) Sensitivity 51.7% 2213 38.4–64.8% (2) 1 Specificity 93.9% 2213 92.8–94.9% (2) 1 Positive predictive value 27.0% 2288 0–97.2% (3) Negative predictive value1 98.6% 2213 95.3–100% (2)
Quality of evidence
Importance
Moderate
CRITICAL
Moderate
CRITICAL
Moderate
CRITICAL
Moderate
CRITICAL
Immunological criteria with definition of virological failure 50–4,999 copies/ml Bibliography: Abouyannis 2011; Chaiwarth 2007; Kantor 2009; Labhardt 2012; Mee 2006; Mee 2008; Meya 2009; Moore 2008; Rawizza 2011; Rewari 2010; Reynolds 2009; van Oosterhout 2009 Settings: India, Kenya, Lesotho, Malawi, Nigeria, South Africa, Thailand, Uganda Comparison: WHO 2010 immunological criteria and VL 50–4999 copies/ml Values and uncertainty Number of participants around these (studies) Sensitivity 55.0% 15 388 53.0–57.0% (9) 1 Specificity 82.9% 15 388 82.2–83.5% (9) Positive predictive value1 38.0% 15 581 22.6–47.2% (12)
Quality of evidence
Importance
Moderate
CRITICAL
Moderate
CRITICAL
Moderate
CRITICAL
1 This work was commissioned by the World Health Organization and carried out by The University of California, San Francisco (UCSF), Cochrane Review Group on HIV/AIDS
WHO/HIV/2013.42
© World Health Organization 2013
Negative predictive value1 90.5% 88.3–95.7%
15 388 (9)
Moderate
CRITICAL
Immunological criteria with definition of virological failure >10 000 copies/ml Bibliography: Keiser 2009; Reynolds 2009 Settings: Africa, South America, Uganda Comparison: WHO 2010 immunological criteria and VL >10 000 copies/ml Values and uncertainty Number of participants around these (studies) Sensitivity 16.8% 3142 11.1–23.9% (2) 1 Specificity 95.5% 3142 94.7–96.2% (2)) Positive predictive value1 15.0% 3142 1.0–36.3% (2) Negative predictive value1 96.0% 3142 80.5–100.0% (2)
Quality of evidence
Importance
Moderate
CRITICAL
Moderate
CRITICAL
Moderate
CRITICAL
Moderate
CRITICAL
Clinical criteria and virological failure Clinical criteria with definition of virological failure >5000 copies/ml Bibliography: Labhardt 2012 Settings: Lesotho Comparison: WHO 2010 clinical criteria and VL >5000 copies/ml Values and uncertainty Number of participants around these (studies) Sensitivity NA 0 Specificity1 NA 0 Positive predictive value1 100% 1 5.5–100% (1) Negative predictive value1 NA 0
Quality of evidence
Importance
Non-existent Non-existent Very low
CRITICAL CRITICAL CRITICAL
Non-existent
CRITICAL
2 This work was commissioned by the World Health Organization and carried out by The University of California, San Francisco (UCSF), Cochrane Review Group on HIV/AIDS
WHO/HIV/2013.42
© World Health Organization 2013
Clinical criteria with definition of virological failure 50–4999 copies/ml Bibliography: Chaiwarth 2007; Hosseinipour 2011; Labhardt 2012; Mee 2006; Mee 2008; Rewari 2010; van Oosterhout 2009 Settings: India, Lesotho, Malawi, South Africa, Thailand Comparison: WHO 2010 clinical criteria and VL 50–4999 copies/ml Values and uncertainty Number of participants around these (studies) Sensitivity 11.0% 919 5.4–19.3% (3) Specificity1 90.5% 919 88.3–92.4% (3) 1 Positive predictive value 45.2% 1047 10.0–75.4% (6) Negative predictive value1 91.1% 919 87.2–92.9% (3)
Quality of evidence
Importance
Moderate
CRITICAL
Moderate
CRITICAL
Moderate
CRITICAL
Moderate
CRITICAL
Immunological OR clinical criteria with definition of virological failure >5000 copies/ml Bibliography: Labhardt 2012 Settings: Lesotho Comparison: WHO 2010 immunological OR clinical criteria and VL >5000 copies/ml Values and uncertainty Number of participants around these (studies) Sensitivity NA 0 Specificity1 NA 0 Positive predictive value1 51.1% 92 40.5–61.6% (1) Negative predictive value1 NA 0
Quality of evidence
Importance
Non-existent Non-existent Very low
CRITICAL CRITICAL CRITICAL
Non-existent
CRITICAL
3 This work was commissioned by the World Health Organization and carried out by The University of California, San Francisco (UCSF), Cochrane Review Group on HIV/AIDS
WHO/HIV/2013.42
© World Health Organization 2013
Immunological OR clinical criteria with definition of virological failure 50–4999 copies/ml Bibliography: Abouyannis 2011; Chaiwarth 2007; Labhardt 2012; Mee 2008; Meya 2009; Rewari 2010; van Oosterhout 2009 Settings: India, Lesotho, Malawi, South Africa, Thailand, Uganda Comparison: WHO 2010 immunological OR clinical criteria and VL 50-4999 copies/ml Values and uncertainty Number of participants around these (studies) Sensitivity 26.6% 896 19.1–35.3% (3) 1 Specificity 86.0% 896 83.8–88.0% (3) Positive predictive value1 49.4% 1583 17.4–63.9% (6) Negative predictive value1 91.1% 896 86.4–94.0% (3)
Quality of evidence
Importance
Moderate
CRITICAL
Moderate
CRITICAL
Moderate
CRITICAL
Moderate
CRITICAL
4 This work was commissioned by the World Health Organization and carried out by The University of California, San Francisco (UCSF), Cochrane Review Group on HIV/AIDS
WHO/HIV/2013.42
© World Health Organization 2013
GRADE tables: How accurately do the WHO 2010 immunological and clinical criteria predict virological failure in children on ART? Authors: George W. Rutherford, Tara Horvath
Immunological criteria and virological failure Immunological criteria with definition of virological failure >5000 copies/ml Bibliography: Barlow-Mosha 2012; Davies, 2012; Westley 2012 Settings: Cambodia, South Africa, Uganda Comparison: WHO 2010 immunological criteria and VL >5000 copies/ml Values and uncertainty Number of participants around these (studies) Sensitivity 4.5% 4100 3.0–6.5% (3) 1 Specificity 99.3% 4100 99.0–99.6% (3) Positive predictive value1 54.9% 4100 5.0 – 100.0% (3) Negative predictive value1 85.5% 4100 62.0 – 99.0% (3)
Quality of evidence
Importance
Moderate
CRITICAL
Moderate
CRITICAL
Moderate
CRITICAL
Moderate
CRITICAL
Immunological criteria with definition of virological failure >400 copies/ml Bibliography: Davies 2011 Settings: South Africa Comparison: WHO 2010 immunological criteria and VL >400 copies/ml Values and uncertainty Number of participants around these (studies) Sensitivity 6.3% 2256 3.4–11.0% (1) 1 Specificity 97.7% 2256 96.9–98.3% (1) Positive predictive value1 20.0% 2256 11.2 – 32.7% (1)
Quality of evidence
Importance
Moderate
CRITICAL
Moderate
CRITICAL
Moderate
CRITICAL
5 This work was commissioned by the World Health Organization and carried out by The University of California, San Francisco (UCSF), Cochrane Review Group on HIV/AIDS
WHO/HIV/2013.42
© World Health Organization 2013
Negative predictive value1 91.8% 90.6 – 92.9%
2256 (1)
Moderate
CRITICAL
6 This work was commissioned by the World Health Organization and carried out by The University of California, San Francisco (UCSF), Cochrane Review Group on HIV/AIDS