RESULTS
herpes simplex
VIRUS, HERPES SIMPLEX
HPTN 071 included 4101 participants who were HIV positive at the start of the study intervention (PC0) and had a sample stored 2 years later (PC24; Figure Identification of viraemic controllers and non‐controllers in HPTN 071 (PopART). The figure shows the approach used to identify viraemic controllers and non‐controllers. The cohort included HPTN 071 (PopART) participants who were HIV positive at study enrolment (PC0) and had a sample available from a study visit 2 years later (PC24). Viral load and antiretroviral (ARV) drug data obtained at the PC24 visit were used to identify potential controllers and non‐controllers. Participants who had viral loads ≥2000 copies/ml with no ARV drugs detected at PC24 were classified as non‐controllers. Participants who had viral loads <2000 copies/ml with no ARV drugs detected at PC24 were classified as potential controllers. Testing was performed at a second study visit (PC0, PC12 or PC36) to identify the subset of potential controllers who met the criteria for viraemic control (viral load <2000 copies/ml with no ARV drugs detected at two visits at least 1 year apart). Shaded boxes indicate participants who had undetermined controller status or were excluded from the analysis due to ARV drug use. To determine which of the 218 potential controllers met the criteria for viraemic control, VL and ARV drug testing were performed using samples collected from a second visit (1–2 years earlier or 1 year later); results were obtained for 210 (96.3%) of the 218 potential controllers. Based on those results, 126 potential controllers were classified as viraemic controllers (VL <2000 copies/ml with no ARV drugs detected at two visits at least a year apart). The remaining 92 participants were excluded from further analysis, since controller status could not be determined based on available data. This group included eight participants who had no additional samples or were missing VL and/or ARV drug data from an additional visit, 49 participants who had VLs ≥2000 copies/ml at the second visit tested; and 35 participants who had VLs <2000 copies/ml with ARV drugs detected at the second visit tested. The final cohort included 126 controllers and 766 non‐controllers. The prevalence of viraemic control among the 4072 participants with PC24 data was 3.1% (95% confidence interval [CI]: 2.6%, 3.6%).We compared demographic and other characteristics for the 126 controllers and 766 non‐controllers (Table Factors associated with viraemic control in HPTN 071 (PopART)
Abbreviations: ARV, antiretroviral; HSV‐2, herpes simplex virus type 2; IQR, interquartile range; N/D, not determined; SD, standard deviation; yrs, years.Participants were classified as controllers if they had viral loads <2000 copies/ml with no ARV drugs detected at two annual study visits.Participants were classified as non‐controllers if they had a viral load ≥2000 copies/ml with no ARV drugs detected at the PC24 visit.Data from viral load testing are shown for the PC24 visit.
Age was analysed as a continuous variable (years) and by age category (18–24 years, 25–29 years, 30–34 years, 35–39 years and 40+ years).Data for HSV‐2 status are shown for the PC0 visit; data were not available for 13 participants (3 controllers and 10 non‐controllers).