PMID- 21756757
OWN - NLM
STAT- MEDLINE
DCOM- 20120202
LR  - 20110715
IS  - 0376-2491 (Print)
IS  - 0376-2491 (Linking)
VI  - 91
IP  - 19
DP  - 2011 May 24
TI  - [Safety study of 52-week highly active antiretroviral therapy in 198 HIV/AIDS 
      Chinese patients].
PG  - 1318-22
AB  - OBJECTIVE: To evaluate the safety profiles of three nevirapine-based therapies 
      for antiretroviral-naive Chinese adults infected with HIV-1 (human 
      immunodeficiency virus-1). METHODS: For this prospective multicentric randomized 
      trial, a total of 198 antiretroviral-naive HIV-1 positive patients were recruited 
      from 13 research centers in China. They were randomly assigned to receive three 
      NVP-based antiretroviral therapies for 52 weeks: Group A, AZT (zidovudine) + DDI 
      (didanosine) + NVP (nevirapine); Group B, D4T (stavudine) + 3TC (lamivudine) + 
      NVP; Group C, AZT + 3TC + NVP. Their clinical events and laboratory examinations 
      were monitored at baseline and the end of weeks 4, 8, 12, 24, 36 & 52 post-HAART 
      (highly active antiretroviral therapy) to evaluate the occurrence of adverse 
      events (AEs). The chi-square or Fisher's exact test was employed to compare the 
      rates of AEs among three treatment groups. Multivariate logistic regression 
      analyses were used to identify the factors associated with hepatotoxicity. For 
      all tests, P < 0.05 was considered as statistically significant. RESULTS: During 
      the 52-week HAART, 968 cases of AEs occurred in 188 patients (95.0%). Only 37.4% 
      experienced grade 3/4 AE. And 37 patients withdrew because of HAART-related AEs 
      (18.7%). The common AEs were hepatotoxicity, bone morrow suppression, 
      gastrointestinal disorders, rash and hyperlipidemia, etc. Most instances of AEs 
      occurred during the early 12 weeks. The total count of AEs for each group had no 
      statistic significant difference (P = 0.403). Bone marrow suppression was more 
      strongly associated with an AZT-containing HAART and it was especially prone to 
      gastrointestinal disorders when combined with DDI. The introduction of D4T or DDI 
      led more frequently to peripheral neuropathy and hyperlipidemia. Logistic 
      regression analysis indicated that presence of hepatotoxicity was associated with 
      a higher baseline level of CD4 (CD4 count > 250/microl) (OR = 2.08, 95%CI: 1.114 - 
      3.882, P = 0.021). CONCLUSION: The common reasons of discontinuing HAART are 
      hepatotoxicity, gastrointestinal disorders, bone marrow suppression and rash. The 
      occurrence of AEs should be vigorously monitored especially during the early 3 
      months of HAART. The HIV/AIDS patients with a CD4 count of > 250/microl shall avoid 
      any NVP-containing regimen.
FAU - Li, Wen-juan
AU  - Li WJ
AD  - Department of Infectious Diseases, Peking Union Medical College Hospital, Chinese 
      Academy of Medical Science and Peking Union Medical College, Beijing 100730, 
      China.
FAU - Dai, Yi
AU  - Dai Y
FAU - Han, Yang
AU  - Han Y
FAU - Qiu, Zhi-feng
AU  - Qiu ZF
FAU - Xie, Jing
AU  - Xie J
FAU - Zuo, Ling-yan
AU  - Zuo LY
FAU - Li, Yan-ling
AU  - Li YL
FAU - Li, Tai-sheng
AU  - Li TS
LA  - chi
PT  - English Abstract
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - China
TA  - Zhonghua Yi Xue Za Zhi
JT  - Zhonghua yi xue za zhi
JID - 7511141
RN  - 0 (Anti-HIV Agents)
SB  - IM
MH  - Acquired Immunodeficiency Syndrome/*drug therapy/virology
MH  - Adult
MH  - Anti-HIV Agents/*adverse effects/therapeutic use
MH  - Antiretroviral Therapy, Highly Active/*adverse effects
MH  - China
MH  - Female
MH  - HIV Infections/*drug therapy/virology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Viral Load
EDAT- 2011/07/16 06:00
MHDA- 2012/02/03 06:00
CRDT- 2011/07/16 06:00
PHST- 2011/07/16 06:00 [entrez]
PHST- 2011/07/16 06:00 [pubmed]
PHST- 2012/02/03 06:00 [medline]
PST - ppublish
SO  - Zhonghua Yi Xue Za Zhi. 2011 May 24;91(19):1318-22.