Wolters Kluwer, November 2019
The short-term safety of treatment interruptions (a necessary part of cure studies) is not well-established, particularly in women and racially diverse populations. NWCS 371(also supported by the IMPAACT network) explored the viral rebound kinetics and safety associated with treatment interruptions among women who underwent ART discontinuation postpartum as part of the international, randomized-controlled PROMISE trial, comparing these results to those from men in historic ACTG interruption trials (ACTG NWCS 371 analytic treatment interruption pooled analysis). The estimated median time to viral rebound among these women was two weeks. An estimated 6 percent of women remained virally suppressed at 30 weeks.
A significantly higher proportion of women in PROMISE (25.4 percent) were virologically suppressed (<400 copies/uL) at 12 weeks compared to ACTG NWCS 371 participants (6.5 percent, p < 0.01). While there were significant differences between participants in PROMISE and ACTG NWCS 371 beyond sex (including older age, longer duration on ART, higher proportion of NNRTI-based regimens, and initiation of ART during acute or early infection in the ACTG NWCS study), researchers found these data striking, as many characteristics of the participants in PROMISE favored more rapid rebound. This study demonstrates that inclusion of women in future cure studies is safe. Future studies of cure research should include both men and women in order to fully represent all people living with HIV.
Time to viral rebound and safety after antiretroviral treatment interruption in postpartum women compared to men.