Treatment interruption after delivery in HIV‐infected women without HAART indications is not safe if initial CD4+ count is less than 700 cells/mm3
Authors: Kaminskiy G , Orlova‐Morozova E , Pronin A 
Published: November 2012

Purpose of the study

To determine safety for the mother of termination after delivery of HAART, initiated with the aim to prevent mother to child transmission.

Methods

640 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 results

Women 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.

image

Differences 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

Conclusions

1. 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.