WHO/HIV/2013.35
© World Health Organization 2013
GRADE tables: What ARV regimen to start with in adults, adolescents and pregnant women living with HIV-2? GRADE table (randomized trial), PI-based regimen versus three NRTIs among HIV-2 or dually reactive patients Quality assessment No. of studies Design No. of patients Effect Relative Absolute (95% CI) Quality Importance
Risk of bias Inconsistency Indirectness Imprecision Other considerations PI-based regimen Three NRTIs 0 0
Mortality (non-accidental deaths as a proportion of patients initiating ART) (observational) 0 Randomized trial CD4 cell increases measured at 24 weeks after ART initiation (observational) 0 Randomized trial
CRITICAL ⊕OOO VERY LOW CRITICAL ⊕OOO VERY LOW CRITICAL ⊕OOO VERY LOW CRITICAL ⊕OOO VERY LOW CRITICAL ⊕OOO VERY LOW CRITICAL ⊕OOO VERY LOW
0
0
-
-
0
Randomized trial
0
0
-
-
0
Randomized trial
0
0
-
-
0
Randomized trial
0
0
-
-
0
Randomized trial
0
0
-
-
References: none
This work was commissioned by the World Health Organization and carried out by Programme PACCI
1
WHO/HIV/2013.35
© World Health Organization 2013
GRADE table (observational studies), PI-based regimen versus three NRTIs among HIV-2 or dually reactive patients
Quality assessment No. of Risk of Other Design Inconsistency Indirectness Imprecision studies bias considerations Mortality (non-accidental deaths as a proportion of patients initiating ART) (observational) 7 observational very Very serious serious serious4 None studies serious CD4 cell increases measured at 24 weeks after ART initiation (observational) 6 observational very serious serious studies serious6 CD4 cell increases measured at 48 weeks after ART initiation (observational) 6 observational very serious serious studies serious6 Viral response at 48 weeks after ART initiation Very serious 5 observational very studies serious6
No. of patients PI-based Three Relative regimen NRTIs (95% CI) 30/697 (4.3%) Not estimated
Effect Quality Importance Absolute CRITICAL
⊕OOO VERY LOW ⊕OOO VERY LOW
very serious7
none
NA
NA
Not estimated
CRITICAL
very serious7
none
+102 –12.6 Not cells/mm3 cells/mm3 estimated
Mean difference9 +114 cells/mm3 higher
⊕OOO VERY LOW
CRITICAL
serious
very serious7
none
NA
NA
Not Mean difference –1.8 log10 ⊕OOO estimated HIV-2 RNA lower (62% VERY undetectable PI versus 17% LOW undetectable) Not estimated ⊕OOO VERY LOW ⊕OOO VERY LOW ⊕OOO VERY LOW
CRITICAL
Drug resistance (observational) 7 observational serious6 studies Adverse events 1 observational studies
serious inconsistency
no serious indirectness
very serious7
none
NA
NA
CRITICAL
serious6
serious inconsistency
no serious indirectness
very serious7
none
NA
NA
Not estimated
CRITICAL
Clinical progression to AIDS 3 observational serious6 studies
serious inconsistency
no serious indirectness
very serious7
none
NA
NA
Not estimated
CRITICAL
This work was commissioned by the World Health Organization and carried out by Programme PACCI
2