Table 2.
Summary of the results obtained for the different outcomes assessed for each primary study
| Study (first author, year) | Number of patients developing AEa | Number of AE | Total number of patients | Total person-years observed | Incidence of individuals with AE, % (95% CI) | Incidence rate of individuals with AE per 100 person-years (95% CI) | Incidence rate of AE per 100 person-years (95% CI) |
|---|---|---|---|---|---|---|---|
| HIV | |||||||
| Khalili et al. (2009) [29] | 131 | * | 150 | * |
87.33 (82.17–92.82) |
* | * |
| Modayil et al. (2010) [30] | * | 159 | 400 | 266.80 | * | * | 59.60 (51.02–69.62) |
| Nagpal et al. (2010) [31] | 213 | 618 | 235 | 117.50 |
90.64 (86.99–94.44) |
181.28 (158.50–207.33) | 525.96 (486.08–569.10) |
| Abaissa et al. (2012) [32] | 116 | 575 | 392 | 79.00 |
29.59 (25.4–34.47) |
146.84 (122.40–176.14) | 727.85 (670.72–789.84) |
| Bernal et al. (2013) [33] | 62 | 76 | 92 | 7.66 |
67.39 (58.46–77.68) |
809.02 (630.75–1037.68) | 991.70 (792.03–1241.72) |
| Bezabhe et al. (2015) [34] | 181 | * | 211 | 196.83 |
85.78 (81.2–90.63) |
91.96 (79.49–106.38) | * |
| Jha et al. (2015) [35] | 43 | 53 | 327 | 54.61 |
13.15 (9.95–17.37) |
78.74 (58.40–106.17) | 97.05 (74.15–127.04) |
| Mann et al. (2016) [12] | 66 | 102 | 413 | 227.15 |
15.98 (12.81–19.94) |
29.06 (22.83–36.98) | 44.90 (36.98–54.52) |
| Gudina et al. (2017) [36] | 867 | 1253 | 3921 | 14,280.28 |
22.11 (20.85–23.45) |
6.07 (5.68–6.49) | 8.77 (8.30–9.27) |
| Isa et al. (2018) [37] | 98 | 313 | 167 | 83.50 |
58.68 (51.67–66.65) |
117.37 (96.28–143.06) | 374.85 (335.54–418.77) |
| Oumar et al. (2019) [38] | 357 | * | 843 | 45.69 |
42.35 (39.14–45.82) |
781.34 (704.35–866.75) | * |
| Sarraf et al. (2020) [39] | 172 | 240 | 496 | 496.00 |
34.68 (30.73–39.13) |
34.68 (29.86–40.27) | 48.39 (42.64–54.91) |
| Omolo et al. (2020) [40] | * | 406 | 343 | 541.94 | * | * | 74.92 (67.97–82.57) |
| Ray et al. (2023) [11] | 78 | 110 | 174 | 87.00 |
44.83 (38.02–52.86) |
89.66 (71.81–111.93) | 126.44 (104.88–152.42) |
| Bonfanti et al. (2000) [41] | 433 | * | 1207 | 1076.64 |
35.87 (33.27–38.68) |
40.22 (36.60–44.19) | * |
| Pujades-Rodríguez et al. (2011) [42] | * | 4878 | 48,785 | 62,505.00 | * | * | 7.80 (7.59–8.03) |
| Hongo et al. (2021) [43] | 565 | * | 2292 | * |
24.65 (22.95–26.48) |
* | * |
| Ann et al. (2019) [44] | 310 | 674 | 600 | 1003.80 |
51.67 (47.82–55.82) |
30.88 (27.63–34.52) | 67.14 (62.26–72.41) |
| Tukei et al. (2012) [45] | 107 | 126 | 378 | 1236.06 |
28.31 (24.11–33.23) |
8.66 (7.16–10.46) | 10.19 (8.56–12.14) |
| Tetteh et al. (2015) [46] | |||||||
| 3TC/AZT for 3 days | 146b | 62 | 101 | 2.77 |
64.04 (58.10–70.58)2 |
5275.71 (4485.74–6204.81) | 2240.37 (1746.69–2873.59) |
| 3TC/AZT for 28 days | 197 | 75 | 7.19 | 2029.89 (1725.94–2387.37) | 2738.96 (2381.99–3149.44) | ||
| 3TC/AZT/LPV-RTV for 28 days | 169 | 52 | 4.99 | 2927.73 (2489.34–3443.33) | 3388.95 (2914.65–3940.42) | ||
| Joseph et al. (2016) [47] | * | 178 | 198 | 198.00 | * | * | 89.90 (77.62–104.13) |
| Jena et al. (2009) [48] | 46 | * | 100 | 50.00 |
46.0 (37.20–56.88) |
92.00 (68.91–122.83) | * |
| Sharma et al. (2008) [49] | 64 | 143 | 90 | 180.00 |
71.11 (62.34–81.12) |
35.56 (27.83–45.43) | 79.44 (67.43–93.59) |
| Influenza | |||||||
| Komeda et al. (2014) [50] | 86 | 143 | 1174 | * |
7.33 (5.98–8.98) |
* | * |
| Komeda et al. (2015) [51] | 245 | 168 | 1199 | * |
20.43 (18.27–22.85) |
* | * |
| Komeda et al. (2016) [52] | 219 | 412 | 770 | * |
28.44 (25.43–31.81) |
* | * |
| Kashiwagi et al. (2012) [53] | 50 | 59 | 3542 | 145.58 |
1.41 (1.07–1.86) |
34.35 (26.03–45.32) | 40.53 (31.4–52.31) |
| Nakano et al. (2021) [54] | 11 | 15 | 1104 | 45.37 |
1.00 (0.55–1.79) |
24.24 (13.43–43.78) | 33.06 (19.93–54.84) |
| Dalvi et al. (2011) [55] | 69 | 146 | 191 | 5.23 |
36.13 (29.92–43.62) |
1318.45 (1041.34–1669.32) | 2789.77 (2372.04–3281.08) |
| Tahara et al. (2013) [56] | 385 | * | 1284 | 98.87 |
29.98 (27.58–32.6) |
389.41 (352.39–430.32) | * |
| Nakazawa et al. (2020) [57] | 345 | * | 3094 | 59.40 |
11.15 (10.09–12.32) |
580.76 (522.60–645.39) | * |
| HCV | |||||||
| Tinè et al. (2010) [58] | 84 | 853 | 312 | 153.82 |
26.92 (22.42–32.32) |
54.61 (44.1–67.63) | 554.56 (518.56–593.05) |
| Suzuki et al. (2018) [59] | 726 | 1063 | 2820 | 1302.84 |
25.74 (24.18–27.41) |
55.72 (51.81–59.93) | 81.59 (76.83–86.65) |
| Ahmed et al. (2018) [60] | 261 | * | 345 | 172.40 |
75.65 (71.26–80.32) |
151.39 (134.10–170.92) | * |
| Mizokami et al. (2021) [61] | 197 | 265 | 3292 | 253.49 |
5.98 (5.23–6.85) |
77.72 (67.59–89.36) | 104.54 (92.68–117.92) |
| HBV | |||||||
| Kim et al. (2018) [62] | 255 | 380 | 3367 | 2383.84 |
7.57 (6.73–8.52) |
10.70 (9.46–12.09) | 15.94 (14.42–17.63) |
AE adverse events, CI confidence interval, HBV hepatitis B virus, HCV hepatitis C virus, HIV human immunodeficiency virus
*Fields left blank indicate that the data were unavailable in the original studies, or that estimating a measure of effect was not feasible due to insufficient data
a Corresponds to the number of people who developed at least one adverse event. Where available, adverse events were collected rather than adverse drug reactions
b The n = 146 corresponds to the overall number of people who developed at least one adverse event (i.e., including all therapeutic regimens). The respective effect measure—cumulative incidence—was calculated based on this value
The estimated effect measures—both cumulative incidence and incidence rates—considered only the values reported for global adverse events, i.e., values reported solely for specific groups of adverse events (e.g., only gastrointestinal disorders), severity levels (e.g., only severe cases), or other restrictive criteria were not included