Fixed-dose combination emtricitabine/tenofovir/efavirenz initiated during acute HIV infection; 96-week efficacy and durability

Abstract

Background: Updated guidelines recommend immediate antiretroviral treatment (ART) during acute HIV infection (AHI), but efficacy data on regimens during AHI are limited.

Methods: We provide final data on a prospective, single-arm 96-week open-label study of once-daily emtricitabine/tenofovir/efavirenz initiated during AHI. The primary endpoint was the proportion of responders with HIV RNA less than 200 copies/ml by week 24. We examined time to viral suppression, retention, and CD8 cell activation through week 96 in relation to baseline characteristics.

Results: Between January 2005 and December 2011, 92 AHI participants enrolled. Most participants (78%) were men who have sex with men (MSM), and 42% were young MSM (18-25 years of age). Two participants withdrew leaving 90 patients for analysis. Eighty-one (90%) remained on therapy and achieved viral suppression to less than 200 copies/ml by week 24, and 71 (79%) to less than 50 copies/ml at week 48. The median time from ART initiation to suppression less than 200 copies/ml was 65 days (range 7-523) and to less than 50 copies/ml was 105 days (range 14-523). The frequency of immune activation declined from a median of 67% to 16% through week 96. Retention on study was maintained in 92% of participants at week 48 and in 83% through week 96. Among 75 participants retained through week 96, 92% were suppressed to less than 50 copies/ml. Among 39 young MSM, 79% completed a week 96 visit and 67% were suppressed at week 96.

Conclusion: ART during AHI resulted in rapid and sustained viral suppression with high rates of retention in care and on ART in this cohort including a large proportion of young MSM.

Conflict of interest statement

Potential Financial Conflicts of Interest: S.W., A.C., J.K., J.S., K.M., M.M., S.F., G.F. - No conflicts.

Figures

Figure 1

Retention among AHI Participants. The figure shows the percentage of participants started on ART during AHI who attended study visits from baseline (week 0) through week 96.

Figure 2. Proportion of participants suppressed, unsuppressed and lost to follow-up on study

LTFU = loss to follow-up

Figure 3

Cumulative incidence of viral load supression

Figure 4

Distribution of immune activation among study participants initiating ART during AHI through week 96 and a seronegative comparison group. The center lines of the boxplots represent the median and the left and right sides of the boxes denote the 25th and 75th percentiles, or interquartile ranges (IQR). The diamond shape represents the mean. The horizontal bars extend to the most extreme data points within 1.5 times the IQR. The circles beyond the lines represent outlying values.