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GRADE table (randomized trial), PI-based regimen versus three NRTIs among HIV-2 or dually reactive patients

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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

(2)

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

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