Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2011 Mar;118(4):495-9.
doi: 10.1111/j.1471-0528.2010.02835.x. Epub 2010 Dec 24.

CD4+ cell count and risk for antiretroviral drug resistance among women using peripartum nevirapine for perinatal HIV prevention

B J Dorton  1 , J Mulindwa, M S Li, N T Chintu, C J Chibwesha, F Mbewe, L M Frenkel, J S A Stringer, B H Chi
Affiliations
Randomized Controlled Trial

CD4+ cell count and risk for antiretroviral drug resistance among women using peripartum nevirapine for perinatal HIV prevention

B J Dorton et al. BJOG. 2011 Mar.

Abstract

Objective: To determine the association between the antenatal CD4(+) cell count and the development of viral drug resistance following the use of peripartum nevirapine (NVP) for perinatal HIV prevention.

Design: Secondary analysis of data from a previously conducted randomised controlled trial.

Setting: Lusaka, Zambia.

Population: HIV-positive pregnant women.

Methods: We analysed the data from a clinical trial of single-dose tenofovir/emtricitabine (TDF/FTC) to reduce viral drug resistance associated with peripartum NVP. The trial population was categorised according to antenatal CD4(+) cell count (200-350, 351-500 and >500 cells/μl).

Main outcome measures: The relative risk for acquiring drug resistance, determined by consensus sequencing and oligonucleotide ligation assay (OLA), was estimated using multivariable logistic regression.

Results: Of the 397 study participants, 119 (30%) had a CD4(+) count of 200-350 cells/μl, 135 (34%) had a CD4(+) count of 351-500 cells/μl and 143 (36%) had a CD4(+) count of >500 cells/μl. Among women receiving no intervention, the risk for drug resistance appeared to increase as the CD4(+) cell count decreased. Participants with CD4(+) cell counts of 200-350 cells/μl randomised to the study arm had the lowest risk, suggesting a higher efficacy of the intervention within this stratum. These results were consistent at 2 and 6 weeks, regardless of how drug resistance was measured.

Conclusions: Women with CD4(+) cell counts of 200-350 cells/μl may be at increased risk for viral drug resistance following the use of peripartum NVP. Given the high prevalence of NVP resistance and the clear benefits of treatment, antiretroviral therapy should be initiated among pregnant women with CD4(+) cell counts of ≤350 cells/μl.

Trial registration: ClinicalTrials.gov NCT00204308.

PubMed Disclaimer

Conflict of interest statement

DISCLOSURE OF INTERESTS

None of the authors have declared financial conflicts of interest.

Figures

Figure 1
Figure 1
Efficacy of adjuvant single-dose tenofovir-emtricitabine (TDF/FTC) stratified across different antenatal CD4+ cell counts, using the control arm as the reference group. This analysis demonstrates that our TDF/FTC intervention was an effect modifier in the relationship between antenatal CD4+ cell count and viral drug resistance. Our study intervention appeared to have greater efficacy among with lower antenatal CD4+ cell counts (i.e., 200–350 cells/µL) at both two and six weeks postpartum, regardless of the assay used to detect viral drug resistance.
See this image and copyright information in PMC

References

    1. Lallemant M, Jourdain G, Le Coeur S, et al. Single-dose perinatal nevirapine plus standard zidovudine to prevent mother-to-child transmission of HIV-1 in Thailand. N Engl J Med. 2004;351:217–228. - PubMed
    1. Jackson JB, Musoke P, Fleming T, et al. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: 18-month follow-up of the HIVNET 012 randomised trial. Lancet. 2003;362:859–868. - PubMed
    1. Guay LA, Musoke P, Fleming T, et al. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial. Lancet. 1999;354:795–802. - PubMed
    1. Arrive E, Newell ML, Ekouevi DK, et al. Prevalence of resistance to nevirapine in mothers and children after single-dose exposure to prevent vertical transmission of HIV-1: a meta-analysis. Int J Epidemiol. 2007;36:1009–1021. - PubMed
    1. Eshleman SH, Mracna M, Guay LA, et al. Selection and fading of resistance mutations in women and infants receiving nevirapine to prevent HIV-1 vertical transmission (HIVNET 012) AIDS. 2001;15:1951–1957. - PubMed

Publication types

Associated data