Table 2.
Rates of endpoints stratified by co-infection status
| Outcome | Infection group | P* | Infection group (considering viral replication) | P† | ||
|---|---|---|---|---|---|---|
| HIV–HBV | HIV | HIV–HBV, VL > 104 copies/mL | HIV | |||
| CD4+ cell count < 350/mm3 at 24 months‡, n (%) | (N = 59) | (N = 544) | (N = 29) | (N = 544) | ||
| Total | 14 (23.7) | 98 (18.0) | 0.3 | 8 (27.6) | 98 (18.0) | 0.2 |
| Continuous | 1 (11.1) | 5 (5.2) | 0.4 | 0 (0) | 5 (5.2) | 0.9 |
| 2/4-ART | 3 (10.7) | 40 (14.5) | 0.8 | 2 (14.3) | 40 (14.5) | 0.9 |
| CD4-guided | 10 (45.5) | 53 (31.0) | 0.17 | 6 (50.0) | 53 (31.0) | 0.17 |
| Death, n events (IR/100 person/years) | (N = 65) | (N = 567) | (N = 33) | (N = 567) | ||
| Total | 3 (1.6) | 5 (0.3) | 0.02 | 3 (4.8) | 5 (0.3) | 0.001 |
| Continuous | 1 (5.1) | 0 (0) | ntp | 1 (14.4) | 0 (0) | ntp |
| 2/4-ART | 1 (1.7) | 2 (0.4) | 0.19 | 1 (3.4) | 2 (0.4) | 0.06 |
| CD4-guided | 1 (2.0) | 3 (0.8) | 0.4 | 1 (3.8) | 3 (0.8) | 0.19 |
| Serious HIV-related morbidity§, n events (IR/100 person/years) | (N = 65) | (N = 567) | (N = 33) | (N = 567) | ||
| Total | 15 (13.2) | 101 (10.0) | 0.3 | 13 (24.0) | 101 (10.0) | 0.002 |
| Continuous | 2 (11.0) | 12 (6.5) | 0.7 | 2 (35.5) | 12 (6.5) | 0.02 |
| 2/4-ART | 5 (9.3) | 48 (9.4) | 0.9 | 4 (14.7) | 48 (9.4) | 0.4 |
| CD4-guided | 8 (19.1) | 41 (13.0) | 0.3 | 7 (33.1) | 41 (13.0) | 0.02 |
| Serious non-HIV-related morbidity‖, n events (IR/100 person/years) | (N = 65) | (N = 567) | (N = 33) | (N = 567) | ||
| Total | 13 (11.5) | 137 (13.9) | 0.5 | 7 (10.7) | 137 (13.9) | 0.7 |
| Continuous | 2 (12.4) | 24 (13.7) | 0.9 | 1 (17.8) | 24 (13.7) | 0.8 |
| 2/4-ART | 4 (9.0) | 40 (12.5) | 0.5 | 3 (12.4) | 40 (12.5) | 0.6 |
| CD4-guided | 7 (13.4) | 73 (14.9) | 0.8 | 3 (11.1) | 73 (14.9) | 0.9 |
ART = antiretroviral therapy; HBV = hepatitis B virus; HIV = human immunodeficiency virus; IR = incidence rates; VL = viral loads.
Comparisons were made between HIV–HBV vs. HIV mono-infected patients.
Comparisons were made between HIV–HBV co-infected patients with high HBV DNA VL vs. HIV mono-infected patients. P values obtained from Pearson’s χ2 test or Fisher’s exact test for categorical variables and from Wald χ2 test after fitting a Cox proportional hazards model. ntp, no test performed.
Of the 632 patients randomized, 29 patients (continuous, N = 3; 2/4-ART, N = 10; CD4-guided, N = 16) were excluded from the CD4 cell count < 350 cells/mm3 analysis because they died (continuous, N = 1; 2/4-ART, N = 3; CD4-guided, N = 4) or were lost to follow-up (continuous, N = 1; 2/4-ART, N = 5; CD4-guided, N = 8) before month 24 or because their CD4 cell count data were missing at month 24 (continuous, N = 1; 2/4-ART, N = 2; CD4-guided, N = 4). The remaining 603 patients (continuous, N = 106; 2/4-ART, N = 304; CD4-guided, N = 193) were included in the intent-to-treat analysis.
Any event leading to death or any morbidity event classified as a World Health Organization (WHO) stage 3 or 4 event.
Any morbidity event that led to death and/or hospital admission and that were not documented as WHO stage 2–4 events.