Virological and immunological responses of efavirenz-based HAART regimen initiated in HIV-infected patients at CD4 < 100 versus CD4 > or = 100 cells/mm3.
OBJECTIVE
To compare virological and immunological responsiveness of efavirenz (EFV)-based highly active anti retroviral therapy (HAART) between patients with baseline CD4 < 100 and CD4 > or = 100 cells/mm3.


METHODS
A prospective cohort study in antiretroviral-naive HIV-infected patients was conducted between February and April 2002. Donated HAART regimen, consisting of stavudine, didanosine, and EFV was initiated. The primary outcome was time to undetectable HIV RNA, < 50 copies/mL. Patients were followed up every 12 weeks until 48 weeks (the end of the study).


RESULTS
Forty-six patients were included, 21 patients for CD4 < 100 cells/mm3 and 25 patients for CD4 > or = 100 cells/mm3. Median CD4 cell counts of these corresponding groups were 26.5 and 177 cells/mm3. Patients' characteristics were similar between the two groups except CD4. The probability of undetectable HIV RNA at 12, 24, 36, and 48 weeks were 57.1% (95% CI, 37.7-78.1%), 76.2% (95% CI, 56.9-91.3%), 80.9% (95% CI, 62.3-94.0%), and 90.5% (95% CI, 68.9-99.1%) for the former group; and 64.0% (95% CI, 45.8-81.8%), 92.0% (95% CI, 77.5-98.6%), 96.0% (95% CI, 83.0-99.7%), and 96.0%.(95% CI, 83.0-99.7%) for the latter group. Median time to undetectable HIV RNA was 12 weeks for both groups. Median CD4 change at 48 weeks was 171 and 132 cells/mm3, respectively (p = 0.232). The adverse events were similar between the two groups.


CONCLUSIONS
Initiation of EFV-based HAART regimen in HIV-infected patients at CD4 < 100 and > or = 100 cells/ mm3 gains similar immunological and virological response.
Kiertiburanakul
Sasisopin
S
Division of lnfectious Diseases, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
Sungkanuparph
Somnuek
S
Rattanasiri
Sasivimol
S
Manosuthi
Weerawat
W
Vibhagool
Asda
A
Thakkinstian
Ammarin
A
D000480:Alkynes; D023241:Antiretroviral Therapy, Highly Active; D048588:Benzoxazines; D018791:CD4 Lymphocyte Count; D015331:Cohort Studies; D003521:Cyclopropanes; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010078:Oxazines / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D012367:RNA, Viral / Q000032:analysis; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*
D000480:Alkynes; D048588:Benzoxazines; D003521:Cyclopropanes; D010078:Oxazines; D012367:RNA, Viral; D018894:Reverse Transcriptase Inhibitors; C098320:efavirenz