Table 2.
Cabotegravir effectiveness, overall and by subgroup
| Events per total PY in cabotegravir group | Events per total PY in TDF-FTC group | HR (95% CI)* | p value | ||
|---|---|---|---|---|---|
| Overall | 4/1956 (0·20%) | 36/1942 (1·85%) | 0·12 (0·05–0·31)† | <0·0001 | |
| Age | .. | .. | .. | 0·53 | |
| <25 years | 3/866 (0·35%) | 20/851 (2·34%) | 0·17 (0·05–0·54) | .. | |
| ≥25 years | 1/1090 (0·09%) | 16/1091 (1·47%) | 0·09 (0·02–0·49) | .. | |
| Contraceptive method | .. | .. | .. | 0·87 | |
| DMPA | 3/1009 (0·30%) | 21/1000 (2·10%) | 0·16 (0·05–0·53) | .. | |
| NET-EN | 1/175 (0·57%) | 6/182 (3·30%) | 0·22 (0·03–1·48) | .. | |
| Implant | 0 | 8/607 (1·32%) | 0·06 (0·00–1·16) | .. | |
| Other | 0 | 1/152 (0·66%) | 0·32 (0·01–9·89) | .. | |
| Body-mass index | .. | .. | .. | .. | |
| ≤30 kg/m2 | 4/1389 (0·29%) | 27/1447 (1·87%) | 0·16 (0·06–0·45) | 0·47 | |
| >30 kg/m2 | 0 | 9/495 (1·82%) | 0·05 (0·00–0·96) | .. | |
HR=hazard ratio. PY=person-years. TDF-FTC=tenofovir disoproxil fumarate plus emtricitabine. DMPA=depot medroxyprogesterone acetate. NET-EN=norethisterone enanthate.
*
Firth's method was used to estimate the HR and 95% CI when the subgroup had zero infections (used for subgroup analysis only, stratified by site).
†
Median unbiased estimate HR (95% CI) for cabotegravir versus TDF-FTC overall displayed.