Table 2.
Efficacy endpoints comparing dolutegravir-based ART with standard of care*
| Dolutegravir | Standard of care | Dolutegravir versus standard of care | |||
|---|---|---|---|---|---|
| Participants | 42 | 43 | .. | ||
| Primary endpoint: virological failure or clinical failure by 96 weeks | |||||
| Participants with virological or clinical failure by 96 weeks | 12 (29%) | 21 (49%) | .. | ||
| Primary endpoint components | |||||
| Insufficient virological response at 24 weeks | 0 | 0 | .. | ||
| Confirmed viral load ≥400 copies per mL at >36 weeks | 9 (21%) | 16 (37%) | .. | ||
| Severe WHO 3 stage event | 0 | 0 | .. | ||
| WHO 4 stage event | 1 (2%) | 1 (2%) | .. | ||
| Death | 2 (5%) | 4 (9%) | .. | ||
| Estimated probability of virological or clinical failure by 96 weeks (95% CI) | |||||
| Frequentist analysis | 0·31 (0·18 to 0·48) | 0·48 (0·35 to 0·63) | −0·18 (−0·36 to 0·02), p=0·057† | ||
| Bayesian analysis | NA | NA | −0·10 (−0·19 to −0·02), p=0·020 | ||
| Secondary endpoint: cross-sectional viral load suppression at 48 weeks‡ | |||||
| Participants with viral load <50 copies per mL at 48 weeks | 15/34 | 19/39 | .. | ||
| Proportion (95% CI) | 44% (28 to 61) | 49% (33 to 65) | −4% (−26 to 19) | ||
| p value | .. | .. | p=0·76 | ||
| Participants with viral load <400 copies per mL at 48 weeks | 25/34 | 27/39 | .. | ||
| Proportion (95% CI) | 74% (56 to 86) | 69% (53 to 82) | 5% (−16 to 26) | ||
| p value | .. | .. | p=0·64 | ||
| Secondary endpoint: cross-sectional viral load suppression at 96 weeks‡ | |||||
| Participants with viral load <50 copies per mL at 96 weeks | 27/35 | 19/36 | .. | ||
| Proportion (95% CI) | 77% (60 to 88) | 53% (36 to 69) | 26% (6 to 47) | ||
| p value | .. | .. | p=0·021 | ||
| Participants with viral load <400 copies per mL at 96 weeks | 33/36 | 26/36 | .. | ||
| Proportion (95% CI) | 92% (76 to 97) | 72% (55 to 85) | 19% (2 to 37) | ||
| p value | .. | .. | p=0·038 | ||
| Secondary endpoint: CD4 cell count, cells per μL§ | |||||
| Mean change (SE) in CD4 cell count from baseline to 96 weeks | 72 (116) | 51 (118) | 30 (95% CI −308 to 368) | ||
| p value | .. | .. | p=0·86 | ||
| Secondary endpoint: CD4 percentage§ | |||||
| Mean change (SE) in CD4 percentage from baseline to 96 weeks | 13% (2) | 8% (2) | 5% (95% CI 0 to 9) | ||
| p value | .. | .. | p=0·053 | ||
NA=not available.
Comparisons of treatment groups are presented for the dolutegravir group as compared with the standard of care group; the probability of having virological or clinical treatment failure by 96 weeks (primary endpoint) was estimated using Kaplan-Meier curves adjusted for trial cohort (ODYSSEY A or ODYSSEY B; appendix p 9); proportions of participants who had other endpoint events at or by 48 or 96 weeks were unadjusted.
p=0·81 for the interaction between trial group (dolutegravir or standard of care) and trial cohort (ODYSSEY A or ODYSSEY B) for the primary endpoint.
The between-group differences in the percentages of participants with a viral load of less than 50 copies per mL and of less than 400 copies per mL at 48 and 96 weeks are the marginal risk differences from the respective logistic regression models and are presented in percentage points.
Mean changes in CD4 count and CD4 percentage from baseline to 96 weeks were calculated with the use of normal regression with adjustment for baseline measure; estimates are presented for mean change from a baseline CD4 count of 1550 cells per μL and a mean change from a baseline CD4 percentage of 24%; the between-group difference in the mean change from baseline was calculated with the use of normal regression with adjustment for baseline measure and enrolment in ODYSSEY A or ODYSSEY B.