Table 3.
Cumulative Incidences and Incidence Rates of Severe Acute Liver Injury Among Initiators of Antiretroviral Drugs and Regimens Within Kaiser Permanente Northern California (2004–2010) and the Veterans Aging Cohort Study (2004–2012), Stratified by the Presence of Viral Hepatitis Coinfection
| Regimen/Drug | Without Viral Hepatitis Coinfection | With Viral Hepatitis Coinfection | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| No. Exposed | No. Events |
Person-Time | Cumulative Incidence at 1 Year/100 Persons (95% CI) |
Incidence Rate, Events/1000 Person-Years (95% CI) |
No. Exposed | No. Events |
Person-Time | Cumulative Incidence at 1 Year/100 Persons (95% CI) |
Incidence Rate, Events/1000 Person-Years (95% CI) |
|
| Overall | 7970 | 14 | 4515 | 0.2 (0.1–0.4) | 3.1 (1.7–5.2) | 2113 | 16 | 1005 | 1.2 (0.7–2.1) | 15.9 (9.1–25.9) |
| NRTI Components | ||||||||||
| TDF/FTC or TDF/3TC | 5762 | 12 | 3486 | 0.3 (0.1–0.5) | 3.4 (1.8–6.0) | 1343 | 9 | 695 | 1.1 (0.5–2.2) | 12.9 (5.9–24.6) |
| ABC/3TC | 392 | 0 | 212 | 0.0 (0.0–0.0) | 0.0 (0.0–14.1) | 162 | 2 | 72 | 1.4 (0.4–5.8) | 27.8 (3.4–100.5) |
| 3TC/ZDV | 1032 | 0 | 482 | 0.0 (0.0–0.0) | 0.0 (0.0–6.2) | 344 | 3 | 135 | 1.7 (0.5–6.0) | 22.2 (4.6–65.0) |
| Othera | 5762 | 2 | 334 | 0.3 (0.1–1.0) | 6.0 (0.7–21.6) | 264 | 2 | 103 | 0.8 (0.2–3.1) | 19.4 (2.4–70.2) |
| Antiretroviral Class | ||||||||||
| Non-NRTI | 4937 | 4 | 2968 | 0.1 (0.0–0.3) | 1.3 (0.4–3.5) | 1148 | 10 | 581 | 1.5 (0.7–3.0) | 17.2 (8.3–31.7) |
| PI | 2520 | 10 | 1303 | 0.5 (0.3–0.9) | 7.7 (3.7–14.1) | 833 | 5 | 373 | 0.7 (0.3–1.6) | 13.4 (4.3–31.3) |
| INSTI | 195 | 0 | 114 | 0.0 (0.0–0.0) | 0.0 (0.0–26.3) | 33 | 0 | 14 | 0.0 (0.0–0.0) | 0.0 (0.0–210.8) |
| Otherb | 318 | 0 | 130 | 0.0 (0.0–0.0) | 0.0 (0.0–23.1) | 99 | 1 | 37 | 1.1 (0.2–7.4) | 27.1 (0.7–151.1) |
| Commonly Used Regimens | ||||||||||
| EFV/TDF/FTC | 3697 | 4 | 2337 | 0.1 (0.0–0.4) | 1.7 (0.5–4.4) | 761 | 6 | 409 | 1.4 (0.6–3.4) | 14.7 (5.4–31.9) |
| ATV/r + TDF/FTC | 854 | 5 | 513 | 0.8 (0.3–1.9) | 9.7 (3.2–22.7) | 256 | 1 | 132 | 0.4 (0.1–2.8) | 7.6 (0.2–42.3) |
| EFV + 3TC/ZDV | 556 | 0 | 271 | 0.0 (0.0–0.0) | 0.0 (0.0–11.1) | 189 | 3 | 74 | 3.2 (0.9–10.9) | 40.3 (8.3–117.9) |
| LPV/r + TDF/FTC | 276 | 2 | 132 | 0.7 (0.2–2.9) | 15.2 (1.8–54.9) | 90 | 0 | 41 | 0.0 (0.0–0.0) | 0.0 (0.0–72.3) |
| LPV/r + 3TC/ZDV | 221 | 0 | 95 | 0.0 (0.0–0.0) | 0.0 (0.0–31.5) | 70 | 0 | 27 | 0.0 (0.0–0.0) | 0.0 (0.0–109.7) |
| DRV/r + TDF/FTC | 224 | 0 | 120 | 0.0 (0.0–0.0) | 0.0 (0.0–25.0) | 46 | 1 | 23 | 2.3 (0.3–15.4) | 43.8 (1.1–244.0) |
| ATV/r + ABC/3TC | 150 | 0 | 81 | 0.0 (0.0–0.0) | 0.0 (0.0–37.0) | 55 | 0 | 26 | 0.0 (0.0–0.0) | 0.0 (0.0–114.4) |
| RAL + TDF/FTC | 174 | 0 | 104 | 0.0 (0.0–0.0) | 0.0 (0.0–28.9) | 28 | 0 | 13 | 0.0 (0.0–0.0) | 0.0 (0.0–222.5) |
| EFV + TDF/3TC | 126 | 0 | 70 | 0.0 (0.0–0.0) | 0.0 (0.0–42.7) | 30 | 0 | 15 | 0.0 (0.0–0.0) | 0.0 (0.0–201.5) |
| EFV + ABC/3TC | 113 | 0 | 66 | 0.0 (0.0–0.0) | 0.0 (0.0–45.3) | 41 | 1 | 19 | 2.4 (0.3–16.1) | 52.2 (1.3–290.8) |
Abbreviations: 3TC, lamivudine; ABC, abacavir; ATV, atazanavir; CI, confidence interval; DRV, darunavir; DTG, dolutegravir; EFV, efavirenz; FTC, emtricitabine; INSTI, integrase strand transfer inhibitor; LPV, lopinavir; NRTI, nucleos(t)ide reverse-transcriptase inhibitor; NVP, nevirapine; PI, protease inhibitor; r, ritonavir; RAL, raltegravir; TDF, tenofovir; ZDV, zidovudine.
a“Other” category includes regimens with <2 NRTIs or alternative NRTI combinations than those listed above.
b“Other” includes regimens unable to be classified in the prior categories, such as those with none or >1 antiretroviral class.