Idenix Pharmaceuticals (IDIX)

[go seek]

any thots on this study? ... from AASLD abstracts

Creatine Kinase (CK) Elevations and Muscle Toxicities Associated with Chronic Telbivudine (LdT) Use in Prospective Clinical Trials
C. A. Brown1; F. Smith2; K. A. Laessig3
1. Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation & Research, US Food & Drug Administration, Silver Spring, MD, USA.
2. Division of Biometrics IV, Office of Biostatistics, Center for Drug Evaluation & Research, US Food & Drug Administration, Silver Spring, MD, USA.
3. Division of Anti-infective & Ophthalmology Products, Office of Antimicrobial Products, Center for Drug Evaluation & Research, US Food & Drug Administration, Silver Spring, MD, USA.


Background: Nucleoside-associated myopathy has been well described in treatment of the Human Immunodeficiency Virus; however CK elevations and myopathy have been a more unusual adverse event with the use of nucleosides for treatment of Hepatitis B Virus (HBV). We reviewed the LdT approval database for CK elevations and adverse event patterns consistent with muscle toxicity.

Methods: Data were reviewed from trials that prospectively measured CK levels and recorded clinical adverse events, and in which LdT was used in at least one arm in New Drug Application 22-011. We examined the time to onset and frequency of CK elevations from the pivotal Phase 3 trial (52 week data) using Kaplan-Meier plots and Fisher’s Exact Analysis (LdT vs. lamivudine (LAM)). We also reviewed detailed event narratives of clinical adverse events (AE) for CK elevations or events suggestiv