|
|
Abstract
ANALYSES OF FOUR KEY CLINICAL TRIALS TO ASSESS THE RISK OF HEPATOTOXICITY WITH NEVIRAPINE: CORRELATION WITH CD4+ LEVELS, HEPATITIS B& C SEROPOSITIVITY, AND BASELINE LIVER FUNCTIONS TESTS.
DIETERICH D, STERN J, ROBINSON P, HALL D, CARLIER H
OBJECTIVES: To assess the incidence of nevirapine (NVP) hepatotoxicity as identifed by adverse events & evaluate markers that may predict increased risk for NVP hepatotoxicity.
METHODS: Four NVP placebo controlled clinical trials (PBO) (n > 2700) were analyzed for liver related adverse events. Events were listed as the WHO preferred terms and were grouped as Hepatitis & Related Hepatic Events (HRHE).
BACKGROUND: Prevalence of underlying liver disease is high among HIV study populations. Hepatotoxicity is a significant concern with ARTs and an important cause for discontinuation or disruption of therapy.
RESULTS: In subjects with advanced HIV disease (n = 2249, median baseline CD4+ = 93) overall 1 yr rate of HRHE was NVP: 3.4%, PBO: 2.2% for a NVP attributable rate of 1.2%. In naïve subjects or those with limited prior ART exposure (n = 456, median baseline CD4+ = 363), the overall 1 yr rate of HRHE was NVP: 8.1%, PBO: 3.0% for a NVP attributable rate of 5.1%. Stratifying by baseline CD4+ < 350 (n = 203) the overall 1 yr rate of HRHE was NVP: 2.9%, PBO: 0% for a NVP attributable rate of 2.9%; while with CD4+ >= 350 (n = 253) the overall 1 yr rate of HRHE was NVP: 13.1%, PBO: 5.0% for a NVP attributable rate of 8.1%. Similar increased NVP HRHE risk factors include baseline ALT/AST >Grade 1 or co-infection with Hep B or C. Data from cohort studies will be presented to show the incidence of hepatic events in NVP treated patients is similar to that of patients treated with other ARTs.
CONCLUSIONS: Population based cohort studies have suggested the incidence of hepatic events in NVP treated patients is low. Observed rates in clinical trials appear to depend on several risk factors: baseline CD4+ >= 350 cells/mm3, baseline ALT/AST or co-infection with Hep B or C.
The 1st. IAS Conference on HIV Pathogenesis and Treatment
Abstract no.
44
Suggested Citation
"DIETERICHD, et al.
ANALYSES OF FOUR KEY CLINICAL TRIALS TO ASSESS THE RISK OF HEPATOTOXICITY WITH NEVIRAPINE: CORRELATION WITH CD4+ LEVELS, HEPATITIS B& C SEROPOSITIVITY, AND BASELINE LIVER FUNCTIONS TESTS..
Oral Presentation:
The 1st. IAS Conference on HIV Pathogenesis and Treatment
:
Abstract no.
44"
|
|
|