Treatment interruption after delivery in HIV‐infected women without HAART indications is not safe if initial CD4+ count is less than 700 cells/mm3

Abstract

Purpose of the studyTo determine safety for the mother of termination after delivery of HAART, initiated with the aim to prevent mother to child transmission.Methods640 HIV‐infected women were randomly selected and evaluated at baseline as not having standard HAART indications [1]. 32 of them got pregnant and short termed HAART (with one boosted protease inhibitor and two nucleoside reverse transcriptase inhibitors) was started at 14–26 week of gestation. It was stopped after delivery and women were additionally followed up for 3 years. Women were divided into 2 groups according to initial CD4+ T‐lymphocyte count: the High Count Group (16 women) 700 to 1200 CD4+cells/mm3, and the Low Count Group (16 women) 500 to 700 CD4+ cells/mm3. Data was subjected to statistical analisys by least square regression and Kaplan‐Meier's method by means of SPSS software [2].Summary of resultsWomen in the High Count Group had stable disease duration and lost at average only 9 CD4+ cells per year (0,9% of CD4+ cell count per year). The average elevation of viral load was 4306 copies per year. Only 6,3% (1 of 16) of women reinitiated HAART in 3 years. Women in the Low Count Group demonstrated immunological disease progression with outstanding loss of 80 CD4+ cells per year (12% of CD4+ cell count per year). Velocity of virological progression was 34940 HIV copies per year. 50% (8 from 16) of women reinitiated HAART in 3 years. 12,5% (2 of 16) of women had symptoms on viral rebound (acute pharyngitis, pneumonia).Kaplan‐Meier curves, indicating women remaining without HAART indications after delivery.imageDifferences in above mentioned indices were statistically significant. Both groups did not differ significantly in age, HIV infection duration, duration of short termed HAART during pregnancy, initial viral load. Even mild immune deficiency 500–700 CD4+ cells/ml results in evidently high velocity of immunological and virological HIV disease progression, leading to soon (within 3 years) HAART reinitiation. Termination of HAART in this case is considered to be not safe. Comparison of High and Low CD4+ Count Groups Index Measure High (700–1200 cells/mm3) CD4+ T‐lymphocyte Count Group Low (500–700 cells/mm3) CD4+ T‐lymphocyte Count Group t Significance (2‐tailed) Average CD4+ Cell Loss cells per year 9,30 79,6 2,312 0,028 Average% CD4+ Cell loss % per year 0,88 12,4 2,727 0,011 Proportion of women, initiated HAART at year 3 % 6,3 50 1,830 0,050 Average Viral Load Year copies/ml 4306 34940 1,378 0,178 Elevation Age years 25,84 26,22 0,278 0,783 Disease duration years 2,43 3,17 0,759 0,454 Short Time HAART Duration days 83,44 77,75 0,461 0,648 Initial Viral Load Log10 copies/ml 4,09 4,25 0,602 0,551 Conclusions1. In case initial CD4+ cell count is less then 700 cells/ml termination of HAART after delivery is not safe and should not be recommended in practice. 2. If initial CD4+ cell count is more then 700 cells/ml HAART may be terminated after delivery but additional studies are needed to evaluate the best appropriate time of termination.