Antiretroviral treatment regardless of CD4 count: the universal answer to a contextual question

Table 2 Main outcomes of the three early ART randomized controlled trials (HPTN052, Temprano ANRS 12136, START)

	Deferred ART		Early ART		Adjusted hazard ratio^f (95 % CI)
	N	Rate per 100 PY	N	Rate per 100 PY	Adjusted hazard ratio^f (95 % CI)
Composite primary outcome
HPTN052	91	4.5	71	3.5	0.73 (0.52–1.03)
Temprano	111	4.9	64	2.8	0.56 (0.41–0.76)
Baseline CD4 < 500	73	5.5	41	3.0	0.56 (0.38–0.83)
Baseline CD4 ≥ 500	38	4.1	23	2.4	0.56 (0.33–0.94)
START	96	1.4	42	0.6	0.43 (0.30–0.62)
Separated outcome
Death^a
HPTN052	15	NA	11	NA	0.73 (0.34–1.59)
Temprano	26	1.9	21	0.8	0.80 (0.45–1.40)
START	21	0.3	12	0.2	0.58 (0.28–1.17)
AIDS^a
HPTN052	61	NA	40	NA	0.64 (0.43–0.96)
Temprano	65	2.8	33	1.4	0.50 (0.33–0.76)
START	50	0.7	14	0.2	0.28 (0.15–0.50)
Tuberculosis^a,b
HPTN052	34	1.8	17	0.8	0.49 (0.28–0.89)
Temprano	55	2.4	28	1.2	0.50 (0.32–0.79)
START	20	0.3	6	0.1	0.29 (0.12–0.73)
AIDS and non-AIDS malignancies^a,c
HPTN052	7	NA	4	NA	NA
Temprano	6	NA	3	NA	NA
START	39	NA	14	NA	NA
Invasive bacterial diseases^d
HPTN052	13	NA	20	NA	NA
Temprano	36	1.5	14	0.6	0.39 (0.21–0.71)
START	36	0.5	14	0.2	0.38 (0.20–0.70)
Serious cardiovascular^e
HPTN052	3	NA	1	NA	NA
Temprano	6	NA	3	NA	NA
START	14	0.20	12	0.17	0.84 (0.39–1.81)

N number of participants who had at least one such type of outcome; ART antiretroviral treatment; NA non available; PY person-years
^aComponent of the composite primary outcome in the three trials
^bTotal number of pulmonary and extra pulmonary TB episodes recorded in the three trials: HPTN052: pulmonary, n = 30 (early: 14; deferred: 16); extra-pulmonary, n = 20 (early: 3; deferred: 17); Temprano ANRS 12136: pulmonary, n = 43 (early: 19; deferred: 24); extra-pulmonary, n = 41 (early: 9; deferred: 33). START: pulmonary, n = 23 (early: 6; deferred: 17); extra-pulmonary, n = 3 (early: 0; deferred: 3)
^cCervical carcinoma, Kaposi’s sarcoma, Lymphoma, Hodgkin’s, Lymphoma, non-Hodgkin’s non-AIDS cancers
^dInvasive bacterial diseases were a component of the composite primary outcome in Temprano and HPTN052, and a secondary outcome in START
^eSerious cardiovascular diseases were a component of the composite primary outcome in START and HPTN052, and a secondary outcome in Temprano
^fThe trials analyses were adjusted for geographic regions (START) or study site (HPTN 052 and Temprano). In Temprano, Hazard Ratios were also adjusted for the IPT/no IPT treatment

ISSN: 1742-6405