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