7.1.2 When to start ART in pregnant and breastfeeding women

Consolidated ARV guidelines, June 2013

Rationale and supporting evidence: Advantages of a standardized ART regimen for all pregnant and breastfeeding women with HIV

Although available data continue to show that the Option A and B prophylaxis regimens have similar efficacy in clinical trial settings (88–92), the complexities of Option A have been an impediment to scaling up PMTCT in many countries. These complexities include different treatment and prophylaxis regimens; the requirement for CD4 measurement to determine treatment eligibility and type of regimen; changing antepartum-intrapartum-postpartum regimens; the need for an additional postpartum ARV “tail” in mothers; and extended NVP prophylaxis in infants.

By contrast, providing an optimized, fixed-dose combination first-line ART regimen of TDF + 3TC (or FTC) + EFV (see section 7.2.2: First-line ART for pregnant and breastfeeding women and ARV drugs for their infants) to all pregnant and breastfeeding women with HIV provides important programmatic and clinical benefits, including the following.

  • Ease of implementation. The same simplified ART regimen is administered to all pregnant women (regardless of “eligibility” for treatment) and continued during pregnancy and labour and postpartum.
  • Harmonized regimens. The optimized first-line fixed-dose combination regimen can be harmonized with guidelines for ART in non-pregnant adults.
  • Increased coverage of ART. This ensures that immunocompromised women who do not have access to CD4 testing receive appropriate ART without delay.
    • Vertical transmission benefit. Provides coverage with ART to maximize the prevention of infant infections.
    • Maternal health benefit. Will delay disease progression over the course of treatment (93).
  • Acceptability. Reviews conducted for these guidelines generally indicated strong community preference and acceptability for this approach.
  • Sexual prevention benefit. ART will reduce sexual transmission of HIV to sexual partners (18).

The Guidelines Development Group also considered the overall evidence from the systematic review of 21 observational studies (19–39) and three randomized controlled trials (3,18,40) used in the evaluation of when to start ART in adults (Web Annex; see section 7.1.1: When to start ART in adults and adolescents). The recommendation to increase the use of ART in pregnant and breastfeeding women is made with the understanding that there are limited ARV drug options in resource-limited countries.

It also recognizes the need to balance the benefits of starting ART in pregnant and breastfeeding women with the possible risks of ARV drug toxicity to the mother and fetus and infant during pregnancy and breastfeeding. Other issues the Guidelines Development Group considered included costs; cost–effectiveness and health system burden (94,95); issues related to adherence and retention (96), HIV drug resistance, ART failure and the availability of future treatment options; and ensuring treatment access for all people who meet current guidelines on eligibility for treatment.