The Cost-Effectiveness of Directly Observed Highly-Active Antiretroviral Therapy in the Third Trimester in HIV-Infected Pregnant Women

Abstract

BackgroundIn HIV-infected pregnant women, viral suppression prevents mother-to-child HIV transmission. Directly observed highly-active antiretroviral therapy (HAART) enhances virological suppression, and could prevent transmission. Our objective was to project the effectiveness and cost-effectiveness of directly observed administration of antiretroviral drugs in pregnancy.Methods and FindingsA mathematical model was created to simulate cohorts of one million asymptomatic HIV-infected pregnant women on HAART, with women randomly assigned self-administered or directly observed antiretroviral therapy (DOT), or no HAART, in a series of Monte Carlo simulations. Our primary outcome was the quality-adjusted life expectancy in years (QALY) of infants born to HIV-infected women, with the rates of Caesarean section and HIV-transmission after DOT use as intermediate outcomes. Both self-administered HAART and DOT were associated with decreased costs and increased life-expectancy relative to no HAART. The use of DOT was associated with a relative risk of HIV transmission of 0.39 relative to conventional HAART; was highly cost-effective in the cohort as a whole (cost-utility ratio $14,233 per QALY); and was cost-saving in women whose viral loads on self-administered HAART would have exceeded 1000 copies/ml. Results were stable in wide-ranging sensitivity analyses, with directly observed therapy cost-saving or highly cost-effective in almost all cases.ConclusionsBased on the best available data, programs that optimize adherence to HAART through direct observation in pregnancy have the potential to diminish mother-to-child HIV transmission in a highly cost-effective manner. Targeted use of DOT in pregnant women with high viral loads, who could otherwise receive self-administered HAART would be a cost-saving intervention. These projections should be tested with randomized clinical trials.

Adherence to antiretroviral therapy during and after pregnancy in low-income, middle-income, and high-income countries

“…The recent changes in WHO recommendations to consider where feasible, the use of cART (instead of single-dose NVP) for prophylaxis in pregnant women reflect the increased effectiveness in PMTCT of longer and more complex regimens [2, 85–87] for the mother coupled with extension of maternal or infant prophylaxis during the neonatal/breastfeeding period [88–90]. The WHO has also endorsed consideration of the approach of initiating life-long cART in all pregnant women regardless of CD4 count, which has been adopted as national policy in Malawi [91, 92]. These new recommendations reflect the benefits of earlier initiation of ART for maternal health and infant survival, as well as to optimize PMTCT.…”

“…Indeed, a trial with peer mentors to improve maternal ART adherence antenatally and at the time of birth is underway in South Africa [90]. Furthermore, using a mathematical model McCabe et al [91] found that programs aimed at optimizing ART adherence using directly observed therapy would be cost-effective to decrease MTCT. Another trial, also underway in South Africa, is investing the role of male involvement on PMTCT ART adherence [92].…”

Individual-Based Simulation Models of HIV Transmission: Reporting Quality and Recommendations

“…The models examined how a variety of HIV interventions such as vaccination [17-22], circumcision [23,24], condom usage [25-32], reduction in concurrency [25,26,29,32-34], HIV testing [15,28,35-37], anti-retroviral treatment [19,22,37-39], STD control [25,29,30,40-45], and prevention of mother to child transmission [18,46,47] can affect HIV incidence and prevalence in a wide variety of settings including North America [15,26,46], Australia [20,35,36] and sub-Saharan Africa [18,19,21,23-25,27,29,30,32-34,37-45,47]. These analyses were able to discuss the effects of interventions in less researched and accessible populations like MSM [15,17,20,22,26,28,35,36] and IDU [15,48].…”

Time to viral load suppression in antiretroviral‐naive and ‐experienced HIV‐infected pregnant women on highly active antiretroviral therapy: implications for pregnant women presenting late in gestation

“…17,20 Our group and others have used creative approaches to optimising adherence, including the use of directly observed therapy on labour and delivery units. [27][28][29][30][31] We also found that use of an NNRTI-based regimen may be associated with increased likelihood of achieving a viral load < 400 copies/ml and <1000 copies/ml. Given updated Centers for Disease Control and Prevention guidelines recommending third-trimester HIV antibody screening in many settings across the USA, there may be an increasing proportion of HIV-infected pregnant women identified later in pregnancy.…”