Table 3.
HSV-2 Incidence According to Treatment Arm, PrEP Intake, and Results of HSV-1 Serology at Baseline: The ANRS Ipergay Trial
| Variable | Total | Treatment | Number of Pills/Montha (TDF/FTC Arm) | HSV-1 Serology at Baselineb | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| n = 218 | TDF/FTC n = 100 |
Placebo n = 118 |
HR (95% CI) |
P | ≤15 n = 54 |
>15 n = 59 |
HR (95% CI) |
P | Negative n = 69 |
Positive n = 149 |
HR (95% CI) |
P | |
| HSV-2 incidence, per 100 PY 95% CI |
7.6 [4.6–11.8] |
8.1 [4.0–14.5] |
7.0 [3.0–13.7] |
1.16 (0.43–3.33) |
.76 | 7.4 [2.4–17.3] |
8.9 [3.3–19.5] |
1.21 (0.31–5.00) |
.77 | 8.4 [3.1–18.2] |
7.3 [3.9–12.4] |
0.87 (0.31–2.78) |
.76 |
Abbreviations: CI, confidence interval; FTC, emtricitabine; HR, hazards ratio; HSV, herpes simplex virus; PrEP, pre-exposure prophylaxis; PY, person-years; TDF, tenofovir disoproxil fumarate.
aSix missing data.
bTwo missing data for HSV-1 status at baseline (equivocal results).