WHO/HIV/2013.11
© World Health Organization 2013
GRADE table: Initiation of ART at CD4 count >350 cells/mm3 compared to <350 cells/mm3 among people coinfected with HIV and hepatitis C virus (HCV) Author(s): Sarah Royce, Andrew Anglemyer Date: 2012-09-12 Question: Should ART be initiated among people coinfected with HIV and hepatitis C virus (HCV) when their CD4 count is >350 cells/mm3 or deferred until their CD4 is ≤350 cells/mm3)? Settings: HIV drug treatment programme in Canada; US sites participating in the AIDS Clinical Trials Group (ACTG) Bibliography: Chung 2002, Moore 2006
Quality assessment
No of patients Relative (95% CI)
Effect Quality Importance Absolute CRITICAL
No. of Risk of Other ART >350 ART ≤350 Design Inconsistency Indirectness Imprecision studies bias considerations cells/mm3 cells/mm3 3 Mortality (non-accidental deaths as a proportion of patients initiating ART with ≥350 versus <350 CD4 cells/mm ) 11 observational very no serious no serious serious4 none5 22/244 99/429 studies serious2 inconsistency indirectness3 (9%) (23.1%) CD4 cell increases measured at 16 weeks after ART initiation (better indicated by higher values) 1 observational very no serious no serious very none studies serious6 inconsistency indirectness serious7 CD4 cell increases measured at 48 weeks after ART initiation (better indicated by higher values) 1 observational very no serious no serious very none studies serious6 inconsistency indirectness serious7 HCV RNA increases measured at 16 weeks after ART initiation (better indicated by lower values) 18 observational serious6 no serious no serious very none studies inconsistency indirectness serious4 HCV RNA increases measured at 48 weeks after ART initiation (better indicated by lower values) 1 observational serious6 no serious no serious very none studies inconsistency indirectness serious7
RR 0.39 141 fewer deaths per 1000 (0.25 to 0.6) (from 92 fewer to 173 fewer) MD9 45 cells/mm3 higher (31.47 lower to 121.47 higher) MD9 5 cells/ mm3 lower (131.02 lower to 121.02 higher)
⊕OOO VERY LOW
30
10
⊕OOO IMPORTANT VERY LOW ⊕OOO IMPORTANT VERY LOW
11
4
-
29
31
-
MD9 0.17 log10 HCV RNA ⊕OOO IMPORTANT lower (0.6 lower to 0.26 VERY higher) LOW
MD9 0.49 log10 HCV RNA ⊕OOO IMPORTANT lower (0.94 to 0.04 lower) VERY LOW 1 Compared ART initiation at CD4 cell counts of ≥350 cells/mm3 versus <350 cells/mm3 groups, which uses a slightly different cutpoint than in the PICO question. 2 Person time of observation within strata not reported. The only data available for this strata-specific analysis were unadjusted. Incomplete ascertainment of outcome if patients moved outside the province. 3 A quarter of the cohort followed was not included due to lack of HCV serology; the missing patients were different than included patients. The patients were HCV antibody positive, but no data were presented on HCV viraemia. 4 Less than 150 cases reported. 5 Large effect (RR< 0.5), but not graded up due to multiple downgrading. 6 Did not adjust for potential confounders (such as age and ART adherence). 13 26 -
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/2013.11
© World Health Organization 2013
7 Very few cases (<50). 8 From six different ACTG treatment trials; the results were published in the same manuscript as the CD4 cell outcomes on this table for a different cohort (which came from one ACTG treatment trial). 9 MD: mean difference. The data reported in the following study are inadequate to test the significance of differences across CD4 cell count strata. Author(s): Sarah Royce, Andrew Anglemyer Date: 2012-09-12 Question: Should ART be initiated among people coinfected with HIV and hepatitis B virus (HBV) and/or hepatitis C virus (HCV) when their CD4 is > 350 cells/µL (or irrespective of CD4 cell count) or deferred until their CD4 is ≤350 cells/mm3 (or they have symptomatic HIV disease, WHO stage 3 or 4)? Settings: Canada Bibliography: Braitstein 2006
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