Carter RJ, Dugan K, El-Sadr WM, et al. CD4+ cell count testing more effective than HIV disease clinical staging in identifying pregnant and postpartum women eligible for antiretroviral therapy in resource-limited settings. J Acquir Immune Defic Syndr. 2010 Jun 30.
Diagnosis of advanced human immunodeficiency virus (HIV) disease in pregnant women and treatment with antiretroviral therapy (ART) are essential components of a comprehensive prevention of mother-to-child transmission (PMTCT) program. Pregnant HIV-infected women who receive ART have less morbidity and mortality, transmit HIV less frequently to their infants, and have higher rates of infant survival. Current World Health Organization (WHO) recommendations call for pregnant women to be treated when they have CD4 cell counts ≤350 cells/µL.(1, 2) Because of the limited access to CD4 count testing, however, only 24% of women in sub-Saharan Africa who were diagnosed with HIV during pregnancy were tested in 2008.(3) Other indicators, such as total lymphocyte count, hemoglobin and clinical staging, have been examined as potential markers for initiation of ART. Earlier studies have found that between 24% and 45% of pregnant HIV-infected women in sub- Saharan Africa have ≤350 CD4 cells/µL,(4, 5) so clinical staging may be less sensitive in this population than in non-pregnant adults, where 63%-81% are at WHO clinical stage 3 or 4 at the time of ART initiation.(6, 7) This study compared WHO clinical staging criteria to CD4 cell count criteria for the determination of ART eligibility in a prepartum and postpartum population in Cameroon, Cote d'Ivoire, Kenya, Mozambique, Rwanda, South Africa, Thailand, Uganda and Zambia.
To compare the sensitivity and specificity of WHO clinical staging for predicting eligibility for ART initiation with CD4 cell counts
MTCT Plus Initiative clinics deliver family-centered care to pregnant and recently postpartum women identified as HIV-infected in PMTCT programs. Participants were program enrollees who had not received ART or short-course ART for perinatal transmission prophylaxis before baseline CD4 cell count.
The outcome variable was ≤350 CD4 cells/µL and the predictor variable was WHO clinical staging criteria.
A total of 4036 women were enrolled (3636 [62%] prepartum and 2300 [38%] postpartum). Seventynine percent of women were classified clinically as WHO stage 1 or 2; 10% had stage 3 and 1% stage 4. Fortyfive percent had ≤350 CD4 cells/µL. Overall, 2915 (48%) of women in the cohort were eligible for ART; 2235 (77%) were eligible based on the CD4 criterion alone, 174 (6%) based on the WHO clinical staging criteria alone and 506 (17%) based on both criteria.
The investigators concluded that almost half the women in this cohort were eligible for ART under the new WHO guidelines but that only 23% would have been identified using clinical criteria alone. They conclude that the failure of clinical staging to identify the large majority of pregnant women who were ARTeligible underscores the need to make CD4 testing routinely available in PMTCT programs.
Using the Newcastle-Ottawa scale, this was a high quality study with no loss to follow-up.
The implication of this study is that PMTCT programs that rely on clinical staging alone to determine whether to start pregnant and postpartum women on ART will miss almost three quarters of eligible women. CD4 cell testing is the gold standard for determining ART eligibility, especially with the new WHO treatment threshold, and should be routinely available in clinical settings where women receive PMTCT care.
- World Health Organization. Antiretroviral therapy for HIV infection in adults and adolescents. Recommendation for a public health approach. 2010 revision). Geneva, Switzerland: World Health Organization, 2010.
- Sturt AS, Dokubo EK. Antiretroviral therapy for treating HIV infection in ART-eligible pregnant women. Cochrane Database Syst Rev. 2010 Mar 17;3:CD008440.
- World Health Organization, UNAIDS, UNICEF. Towards universal access: scaling up priority HIV/AIDS interventions in the health sector- Progress report 2008. Geneva, Switzerland: World Health Organization, UNAIDS, UNICEF; 2008:1-148.
- Stinson K, Myer L, Boulle A. An evaluation of approaches to the initiation of antiretroviral therapy during pregnancy among HIV-infected women in Cape Town. Cape Town, South Africa: University of Cape Town; 2008:1-33. Abstract not available.
- Tsague L, Tene G, Adje-Toure C, et al. Rapid implementation of more efficacious ART regimens for the prevention of mother-to-child transmission of HIV in Rwanda (Paper 830). Presented at: 15th Conference on Retroviruses and Opportunistic Infections; Boston, MA, 2008.
- Stringer JS, Zulu I, Levy J, et al. Rapid scale-up of antiretroviral therapy at primary care sites in Zambia: feasibility and early outcomes. JAMA. 2006; 296:782-793.
- Toure S, Kouadio B, Seyler C, et al. Rapid scaling-up of antiretroviral therapy in 10,000 adults in Cote d'Ivoire: 2-year outcomes and determinants. AIDS. 2008;22:873-882.