Table 3.
Summary of adverse events described for dolutegravir with a frequency ≥ 5% in the different studies, both in treatment-naïve (50 mg once daily) and in treatment-experienced (50 mg twice daily) subjects with human immunodeficiency virus type-1
| DTG 50 mg QD (n = 980) | DTG 50 mg BID (n = 234) | |
|---|---|---|
| Diarrhea | 11%–17% | 5% |
| Nasopharyngitis | 11%–15% | – |
| Nausea | 12%–14% | 5% |
| Headache | 12%–13% | 5% |
| Fatigue | 5%–13% | – |
| Insomnia | 5%–11% | – |
| Dizziness | 6%–9% | – |
| Abnormal dreams | 7% | – |
| Upper respiratory | 5%–6% | – |
| tract infections | ||
| Pyrexia | 5% | – |
| Depression | 5% | – |
Abbreviations: DTG, dolutegravir; QD, once daily; BID, twice daily.