Sustained efficacy of nevirapine in combination with two nucleoside analogues in the treatment of HIV-infected patients: a 48-week retrospective multicenter study.
BACKGROUND
Nevirapine, a nonnucleoside analogue, has demonstrated suppression of human immunodeficiency virus (HIV) replication alone and in combination therapy. However, the durable suppression of HIV with nevirapine when used along with other nucleosides in HIV-infected patients who are treated in clinical practice needs further evaluation.


OBJECTIVE
To evaluate the sustained efficacy of nevirapine in combination with two nucleoside analogues in the treatment of HIV-infected patients in routine clinical practice.


METHODS
A multicenter study from January 1997 to December 2000, with follow-up through 48 weeks, was conducted at four different genitourinary medicine clinics in the United Kingdom. Forty-four HIV-infected patients received nevirapine and two nucleoside analogues. Information from case notes regarding age, sex, side effects, viral load, and CD4 lymphocyte counts at baseline, 24 weeks, and 48 weeks was collected and analyzed. Virologic suppression, defined as HIV RNA concentration of less than 400 copies/mL at Weeks 24 and 48, was considered as the main outcome measure.


RESULTS
Out of 44 patients, 41 were men with a mean age of 39.3 years (95% CI 36.7-41.8). The baseline viral load was 2.11 x 10(2) to 9.74 x 10(5) copies/mL (median 7.7 x 10(4) and CD4 counts 6 to 605 cells/dL (M = 247; 95% CI 198-295). Of 39 patients who completed 48 weeks of treatment, viral load suppression was attained in 31 patients (79.4%; 95% CI 66.8-92.0) at 24 weeks and in 27 patients (69.2%; 95% CI 54-83) at 48 weeks. The CD4 lymphocyte count increased in 32 (82%) patients (mean 106 cells/dL, 95% CI 73-139, p =.0001, Wilcoxon signed rank test) after 24 weeks and in 33 (84.6%) patients (mean 160 cells/dL, 95% CI 115-204, p =.0001, Wilcoxon signed rank test) after 48 weeks of treatment. Of 20 patients whose baseline viral load was <100000, 16 had viral load suppressed at 24 weeks and 15 at 48 weeks (p =.6, chi-square test).


CONCLUSIONS
A regime of nevirapine with two nucleoside analogues provided durable suppression of plasma viral load in HIV infected patients, with significant improvement in the CD4 cell count.
Allan
P S
PS
Department of GU Medicine, Coventry, United Kingdom. sris.allan@coventrypct.nhs.uk
Arumainayagam
J
J
Harindra
V
V
Tobin
J
J
Browning
M
M
Yoganathan
K
K
Wade
A
A
Das
S
S
D000328:Adult; D018791:CD4 Lymphocyte Count; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D015497:HIV-1 / Q000187:drug effects; D006801:Humans; D008297:Male; D019829:Nevirapine / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D009705:Nucleosides / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D012189:Retrospective Studies; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D013997:Time Factors; D019562:Viral Load
D009705:Nucleosides; D018894:Reverse Transcriptase Inhibitors; D019829:Nevirapine