A study called PROMISE-EPI is being conducted in Zambia and Burkina Faso to improve the prevention of postnatal HIV transmission.
In a groundbreaking study published in The Lancet, researchers conducted a Phase 3, open-label, randomized controlled trial known as the Optimised Prevention of Postnatal HIV Transmission in Zambia and Burkina Faso (PROMISE-EPI). The study aimed to address the significant issue of pediatric HIV infections worldwide, with a particular focus on transmission through breastfeeding.
The researchers proposed that extended postnatal prophylaxis with lamivudine, guided by point-of-care assays for maternal viral load, could potentially reduce postnatal HIV transmission in addition to maternal antiretroviral therapy (ART). The trial was conducted at four health-care facilities in Zambia and four in Burkina Faso, targeting mothers with HIV and their breastfed infants without HIV attending the second visit of the Expanded Programme of Immunisation (EPI-2) at 6–8 weeks of age.
Mothers and infants were randomly assigned in a 1:1 ratio to either the intervention or control group. In the intervention group, maternal viral load was monitored using the Xpert HIV viral load assay at EPI-2 and 6 months, with immediate result provision. Infants born to mothers with a viral load of 1000 copies per mL or higher were administered lamivudine syrup twice daily for 12 months or until breastfeeding cessation. The control group followed national guidelines for preventing postnatal HIV transmission.
Between December 2019 and September 2021, 1506 mothers with HIV and their uninfected infants were enrolled in the study, with 753 in each group. The median age of the mothers was 30.6 years, with the majority already receiving ART. Notably, 11.5% of the mothers had a viral load equal to or exceeding 1000 copies/mL at baseline.
The primary outcome, infant HIV infection at 12 months, was assessed using HIV DNA point-of-care testing at 6 and 12 months. The results showed one case of HIV transmission in the intervention group compared to six cases in the control group. The incidence rate of transmission was 0.19 per 100 person-years in the intervention group and 1.16 per 100 person-years in the control group, though statistical significance was not achieved (p=0.066). Both groups exhibited similar HIV-free survival rates and rates of serious adverse events.
This innovative intervention, implemented early in the postnatal period and employing extended single-drug prophylaxis guided by maternal viral load, shows promise as a vital strategy for eliminating pediatric HIV transmission. The study was funded by the EDCTP2 program with support from the UK Department of Health & Social Care.
The implications of this research are significant for global efforts to combat pediatric HIV infections, particularly in regions where breastfeeding remains a common practice and a potential route of transmission. By tailoring prophylactic measures based on maternal viral load, the study provides a tailored approach that could have a substantial impact on reducing the incidence of postnatal HIV transmission.
This study sheds light on the importance of early intervention and personalized healthcare strategies in addressing complex public health challenges like HIV transmission. It underscores the potential of leveraging technological advancements, such as point-of-care assays, to optimize treatment and prevention protocols, ultimately contributing to the goal of pediatric HIV elimination.
Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)02464-9/fulltext
The researchers proposed that extended postnatal prophylaxis with lamivudine, guided by point-of-care assays for maternal viral load, could potentially reduce postnatal HIV transmission in addition to maternal antiretroviral therapy (ART). The trial was conducted at four health-care facilities in Zambia and four in Burkina Faso, targeting mothers with HIV and their breastfed infants without HIV attending the second visit of the Expanded Programme of Immunisation (EPI-2) at 6–8 weeks of age.
Mothers and infants were randomly assigned in a 1:1 ratio to either the intervention or control group. In the intervention group, maternal viral load was monitored using the Xpert HIV viral load assay at EPI-2 and 6 months, with immediate result provision. Infants born to mothers with a viral load of 1000 copies per mL or higher were administered lamivudine syrup twice daily for 12 months or until breastfeeding cessation. The control group followed national guidelines for preventing postnatal HIV transmission.
Between December 2019 and September 2021, 1506 mothers with HIV and their uninfected infants were enrolled in the study, with 753 in each group. The median age of the mothers was 30.6 years, with the majority already receiving ART. Notably, 11.5% of the mothers had a viral load equal to or exceeding 1000 copies/mL at baseline.
The primary outcome, infant HIV infection at 12 months, was assessed using HIV DNA point-of-care testing at 6 and 12 months. The results showed one case of HIV transmission in the intervention group compared to six cases in the control group. The incidence rate of transmission was 0.19 per 100 person-years in the intervention group and 1.16 per 100 person-years in the control group, though statistical significance was not achieved (p=0.066). Both groups exhibited similar HIV-free survival rates and rates of serious adverse events.
This innovative intervention, implemented early in the postnatal period and employing extended single-drug prophylaxis guided by maternal viral load, shows promise as a vital strategy for eliminating pediatric HIV transmission. The study was funded by the EDCTP2 program with support from the UK Department of Health & Social Care.
The implications of this research are significant for global efforts to combat pediatric HIV infections, particularly in regions where breastfeeding remains a common practice and a potential route of transmission. By tailoring prophylactic measures based on maternal viral load, the study provides a tailored approach that could have a substantial impact on reducing the incidence of postnatal HIV transmission.
This study sheds light on the importance of early intervention and personalized healthcare strategies in addressing complex public health challenges like HIV transmission. It underscores the potential of leveraging technological advancements, such as point-of-care assays, to optimize treatment and prevention protocols, ultimately contributing to the goal of pediatric HIV elimination.
Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)02464-9/fulltext
Comments
Post a Comment