Table 5.
Most Common Grade 3 or 4 Laboratory Findings Through Week 96a
| Criterion | Participants Meeting Criterionb/Participants With ≥1 Postbaseline Test, No. (%) | Difference, % (95% CIc) | |
|---|---|---|---|
| DOR/3TC/TDF | EFV/FTC/TDF | ||
| Fasting LDL-C ≥190 mg/dL (grade 3) | 1/332 (0.3) | 5/310 (1.6) | −1.3 (−3.5 to .2) |
| Fasting triglycerides >500 to 1000 mg/dL (grade 3) | 2/336 (0.6) | 9/319 (2.8) | −2.2 (−4.7 to −.3) |
| Creatinine >1.8 to <3.5 × ULN, or increase to 1.5 to <2.0 × baseline (in mg/dL; grade 3) | 10/363 (2.8) | 5/359 (1.4) | 1.4 (−.8 to 3.8) |
| AST 5.0 to <10.0 × ULN (in IU/L; grade 3) | 2/363 (0.6) | 11/359 (3.1) | −2.5 (−4.9 to −0.7) |
| ALT 5.0 to <10.0 × ULN (in IU/L; grade 3) | 3/363 (0.8) | 7/359 (1.9) | −1.1 (−3.2 to 0.7) |
| Lipase 3.0 to <5.0 × ULN (in IU/L; grade 3) | 4/363 (1.1) | 7/359 (1.9) | −0.8 (−3.0 to 1.1) |
| Creatine kinase | |||
| 10.0 to < 20.0 × ULN (grade 3) | 12/363 (3.3) | 12/359 (3.3) | −0.0 (−2.8 to 2.7) |
| ≥20.0 × ULN (grade 4) | 4/363 (1.1) | 10/359 (2.8) | −1.7 (−4.1 to 0.4) |
Abbreviations: 3TC, lamivudine; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CI, confidence interval; DOR, doravirine; EFV, efavirenz; FTC, emtricitabine; LDL-C, low-density lipoprotein cholesterol; TDF, tenofovir disoproxil fumarate; ULN, upper limit of normal range.
aThe most common findings were defined as those occurring in ≥4 participants in either treatment group.
bParticipants are counted once per test in the highest grade reported. Only participants with a worsened grade relative to baseline are included.
cThe 95% CIs were calculated using Miettinen and Nurminen method.