428. High Rates of Adverse Drug Reactions to Nevirapine in Filipino HIV Patients
Session: Poster Abstract Session: HIV - Antiretroviral Therapy
Friday, October 21, 2011
Room: Poster Hall B1
Handouts
  • Roman_Salvana_IDSAPoster428.pdf (1.1 MB)
  • Background: New HIV infections in the Philippines have increased by more than 500% in the last five years. Our clinic at the Philippine General Hospital (PGH) has seen a large increase in the number of patients enrolled and started on antiretrovirals (ARVs). Local guidelines include the combination of zidovudine, lamivudine, and nevirapine as first-line treatment. When a large number of patients developed adverse reactions (ADRs) to nevirapine, we decided to investigate and compare our ADR rates to those reported in literature.

    Methods: We did a retrospective review of an existing de-identified database of clinic patients. Patients enrolled from 2006 to 2011 and started on ARVs were included. ADR rates were calculated and compared to the latest available product literature.

    Results: A total of 132 patients were started on ARVs during the study period. Of these, 59 received nevirapine as part of their initial regimen. Out of the 59 patients who received nevirapine, 3 were female and 56 were male. One woman received nevirapine with a CD4 count>250 cells/mL. All males had CD4 counts <400 cells/mL. Twelve out of the 59 patients (20.3%) (1 female) developed an adverse drug reaction. Median time to ADR development was 2 weeks. Of these, 11 (18.6%) were drug rash including 3 (5.1%) (all male) that developed into pathology-proven Stevens-Johnson Syndrome (SJS). Two patients (3.4%) (both male) developed clinically significant hepatitis (one of whom also developed a rash). Average CD4 count was 191 cells/mL. CD4 count did not differ between those who developed a reaction and those who did not (p=0.91 by t-test). No deaths occurred. All patients recovered after switching to alternative regimens without nevirapine.

    Conclusion: Our overall ADR rates (20.3%) were similar to those reported in literature (14.5-31.6%). Drug rash rates (18.6%) were much higher than in literature (5.1-6.7%). Rates of SJS (5.1%) were alarming compared to literature (0.3%). Hepatotoxicity (3.3%) was similar to reported literature and did not occur in the woman with CD4 count>250 cells/mL. Based on these results, we recommend that nevirapine no longer be used as first-line therapy in the Philippines.


    Subject Category: H. HIV/AIDS and other retroviruses

    Arthur Dessi Roman, MD1, Katerina Leyritana, MD1, Allan Tenorio, MD1,2, Marissa Alejandria, MD1, Jodor Lim, MD1 and Edsel Maurice Salvana, MD1,2, (1)Medicine, UP - Philippine General Hospital, Manila, Philippines, (2)National Institutes of Health - University of the Philippines Manila, Manila, Philippines

    Disclosures:

    A. D. Roman, None

    K. Leyritana, None

    A. Tenorio, None

    M. Alejandria, None

    J. Lim, None

    E. M. Salvana, None

    Findings in the abstracts are embargoed until 12:01 a.m. EST Thursday, Oct. 20 with the exception of research findings presented at IDSA press conferences.