WHO/HIV/2013.53 © World Health Organization 2013
Safety of efavirenz in the first-trimester of pregnancy: an updated systematic review and meta-analysis Nathan Ford,
1Zara Shubber,
1Alexandra Calmy,
1,3Isabelle Andrieux-Meyer,
11. Médecins Sans Frontières, 78 rue de Lausanne, 1211 Geneva, Switzerland
2. Department of Epidemiology and Biostatics, Faculty of Medicine, Imperial College, London, UK.
3. HIV/AIDS Unit, Infectious Disease Service, Geneva University Hospital, Geneva. Switzerland.
4. Department of HIV/AIDS, World Health Organization, Geneva, Switzerland
Correspondence: Dr Nathan Ford, Médecins Sans Frontières78 rue de Lausanne, 1211 Geneva, Switzerland. Email: nathan.ford@msf.org
GRADE assessment for the primary outcome of congenital abnormalities
Quality assessment No of patients Effect
Quality Importance No of
studies Design Risk
of bias Inconsistency Indirectness Imprecision Other
considerations Efavirenz Control Relative
(95% CI) Absolute congenital abnormalities
12 observational studies
no serious risk of bias
no serious inconsistency1
no serious indirectness
no serious imprecision2
none 39/1378
(2.8%)
347/8934 (3.9%)
RR 0.81 (0.58 to 1.13)
1 fewer per 100 (from 2 fewer to 1
more)
⊕⊕ΟΟ LOW
CRITICAL
0%
-
1 Confidence intervals all overlap and no statistical heterogeneity. 2 study has point estimate inconsistent with the overall result but this is based on a low sample size and event rate (1/18 patients exposed to EFV)
2 Confidence intervals cross the null but are narrow enough to rule out appreciable harm/benefit
