Table 2.
Early upper gastrointestinal adverse events, by drug regimen (n=197)
| TDF/FTC +ZDV (n=71)‡ | TDF/FTC +EFV (n=126)‡‡ | p | |
|---|---|---|---|
| Adverse events within first month of treatment, n (%) | 0.0001 | ||
| None | 13 (18%) | 90 (71%) | |
| Moderate* | 41 (58%) | 33 (26%) | |
| Serious** | 17 (24%) | 3 (2%) | |
| Grade 3 or 4† | 12 (17%) | 3 (2%) | |
| Grade 2>1 month & drug discontinuation, n (%) | 5 (7%) | 0 | |
| Characteristics recorded at Month-1 visit, n (%) | |||
| Treatment interruption ≥7 days within first month | 3 (4%) | 1 (0.8%) | – |
| At least 1 pill missed (last 4 days questionnaire) | 14 (21%) | 10 (8%) | 0.02 |
| Characteristics recorded at Month-6 visit | |||
| CD4 change at Month-6 (cells/mm3), median (IQR) | +90 (−8; +175) | +123 (−12; +226) | 0.28 |
| HIV-1 RNA>300 copies/ml at Month-6, n (%) | 14 (21%) | 15 (12%) | 0.13 |
n: number; %: percentage; IQR: interquartile range; mm3: cubic millimetre.
TDF: tenofovir; FTC: emtricitabine; ZDV: zidovudine; EFV: efavirenz.
Moderate: grade 1 or 2, without drug discontinuation.
Serious: grade 3 or 4, or persistent grade 2>1 months leading to drug discontinuation.
Grade 3–4 vomiting, n=10; grade 3–4 nausea with grade 1–2 vomiting, n=5.
69 out the 71 patients (97%) on TDF/FTC+ZDV were women. Of the two men who started on TDF/FTC+ZDV, one had moderate digestive AEs and continued the treatment, and the other one had grade 2>1 month AEs leading to drug discontinuation.
81 out the 126 patients (64%) on TDF/FTC+EFV were women. Among the 81 women who started on TDF/FTC+EFV, 27 (33%) had moderate digestive AEs and 3 (4%) had serious digestive AEs.