Koegl C, Wolf E, Ruemmelein N, Morbach K, Buchberger A, Wandel J, Jaeger H; International Conference on AIDS (15th : 2004 : Bangkok, Thailand).

Int Conf AIDS. 2004 Jul 11-16; 15: abstract no. WePeB5933.

MUC Research GmbH, Munich, Germany

Background: Treatment with Nevirapine (NVP)-containing regimen is associated with hepatotoxicity. Methods: Retrospective follow-up study of an outpatient clinic HIV cohort (N=448) being started on NVP between 1996 and 2003. Liver toxicity was evaluated according to WHO grading (WHO grade 1-2: 1.25 - 5 times upper limit of normal ranges (ULN) of gamma GT, GPT and AP; WHO grade 3-4: >5 times of ULN of gamma GT, GPT and AP), respectively. Results: 448 patients (pts) (21% female) received NVP as part of HAART. 6% of the pts were co-infected with hepatitis B and 9% with hepatitis C. Kaplan-Meyer probability to stay one year (two years) on NVP was 51% (39%). The median treatment time was 13 months. 7% stopped NVP due to liver toxicity after a median treatment time of 4.2 months. 25% of these pts were co-infected with hepatitis B or C. In pts with normal gamma GT values at baseline (N = 290), gamma GT increased to WHO grade 1-2 in 33% (97/290), to WHO grade 3-4 in 5% (15/290) and stayed within normal ranges in 62% (LOCF; last observation carried forward). In 8% increase in gamma GT was accompanied by an increase in AP to WHO grade 1-2. In pts with elevated gamma GT of WHO grade 1-2 at baseline, gamma GT increased to WHO grade 3-4 in 16% (N= 14/85), remained stable in 70% and decreased to normal values in 14%. In pts with normal GPT values at baseline, GPT increased to WHO grade 1-2 in 12% (N= 39/318), to WHO grade 3-4 in 2% (N=7/318) and stayed within normal ranges in 86%. In pts with GPT values WHO grade 1-2 at baseline, normal GPT levels were reinstated in 49% (N= 30/61), GPT remained stable in 41% and increased to WHO grade 3-4 in 10% of pts (N=6/61). Conclusions: In a cohort of 418 pts, in 7% hepatotoxicity led to discontinuation of NVP. Most frequent changes were increases in gamma GT (34%). Only 2% of pts with normal GPT values at baseline experienced a WHO grade 3-4 increase in GPT compared to 10% of pts with a baseline GPT elevation of WHO grade 1-2.

Publication Types:

• Meeting Abstracts

Keywords:

• Acquired Immunodeficiency Syndrome
• Alanine Transaminase
• Antiretroviral Therapy, Highly Active
• Female
• Follow-Up Studies
• HIV Infections
• Hepatitis B
• Hepatitis C
• Humans
• Liver
• Liver Diseases
• Liver Function Tests
• Nevirapine
• adverse effects
• drug therapy
• epidemiology
• gamma-Glutamyltransferase
• poisoning
• surgery
• toxicity

Other ID:

• GWAIDS0039644

UI: 102283860

From Meeting Abstracts