Table 3.
Summary of retrospectively identified long-term safety and other selected endpoints.
| MVC 300 mg b.i.d. (n = 360) PY = 1243.3 | EFV 600 mg q.d. (n = 361) PY = 1204.1 | |||||||
| Total events | n (%) | Raw ratea | Exposure-adjusted rateb | Total events | n (%) | Raw ratea | Exposure-adjusted rateb | |
| Any event | 50 | 38 (10.6) | 4.0 | 3.3 | 62 | 45 (12.5) | 5.1 | 4.0 |
| Hepatic failure | 0 | 0 | 0.0 | 0.0 | 0 | 0 (0.0) | 0.0 | 0.0 |
| MI/cardiac ischemia | 6 | 5 (1.4) | 0.5 | 0.4 | 6 | 6 (1.7) | 0.5 | 0.5 |
| Malignancies | 8 | 7 (1.9) | 0.6 | 0.6 | 14 | 13 (3.6) | 1.2 | 1.1 |
| CDC category C events | 12 | 11 (3.1) | 1.0 | 0.9 | 16 | 14 (3.9) | 1.3 | 1.2 |
| Infections reported as serious AEs | 28 | 24 (6.7) | 2.3 | 2.0 | 35 | 25 (6.9) | 2.9 | 2.2 |
| Rhabdomyolysis | 0 | 0 | 0.0 | 0.0 | 0 | 0 | 0.0 | 0.0 |
AE, adverse event; b.i.d., twice daily; CDC, Center for Disease Control; EFV, efavirenz; MI, myocardial infarction; MVC, maraviroc; PY, patient-years; q.d., once daily.
aTotal number of events/100 PY.
bEvents/100 PY based on time to first event.