Full
Outline
To evaluate the long-term safety, tolerability, and efficacy of antiretroviral therapy (ART) regimen with rilpivirine (RPV) combined with two nucleoside reverse transcriptase inhibitors (N[t]RTIs) in human immunodeficiency virus (HIV)-infected Chinese subjects.
This is a Chinese subgroup study derived from the clinical study, TMC278-TiDP6-C222, which is a phase Ⅲ open-label multicenter, roll-over study. Patients received RPV 25 mg once daily (qd) in combination with two N[t]RTLs. The benefits from RPV treatment were evaluated by efficacy (HIV-1 RNA and CD4+ cell count) and safety (AE, SAE).
Overall, 26 HIV-1 infected Chinese subjects were treated in this extended C222 study. AE leading to permanent discontinuation of study drug were reported in one (3.8%) subject. Most AEs were grade 1 or 2 in severity. Grade 3 or 4 AEs were reported in two (7.7%) subjects. No RPV-related serious AEs (SAEs) were reported. During follow-up, only one (3.8%) subject experienced a blip between week 96 to week 120 (242 copies·mL-1) and then returned to VL<50 copies·mL-1 subsequently. All patients had at least one time of CD4>500 cell·mL-1 and the CD4+ cell count gradually increased over time until week 336 except a decrease occurred between week 192 to week 240.
Long-term treatment with RPV 25 mg qd in combination with two N(t) RTIs is effective, generally safe and well tolerated in Chinese adult patients with HIV-1 infection.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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