http://download.journals.elsevierhealth.com/pdfs/journals/0168-8278/PIIS0168827811607071.pdf
VITAMIN D SUPPLEMENT PREVENTS MYALGIA AND ELEVATION
OF CPK IN CHRONIC HEPATITIS B PATIENTS TREATED WITH
TELBIVUDINE
Background: Telbivudine is a nucleoside analog used as first line
therapy in patients with chronic HBV infection in Israel. Myopathy
and neuropathy have been reported in patients who received
telbivudine treatment. Vitamin D has been shown to improve test
of muscle function and impact on muscle fiber composition.
Aim: To examine whether adding vitamin D to telbivudine therapy
could improve adverse events of muscle pain and weakness and
prevent Creatine Kinas (CK) elevation.
Methods: 30 patients with HBeAg negative chronic HBV infection
(treatment group, age 41±13 yrs, BMI 25±4, 56% male; 19 Arabs,
9 Jewish, and 2 of Russian descent) received telbivudine 600 mg
daily plus vitamin D3 (Vitamydine drops (Fischer), 2000 IU/d, were
compared to the historical control group who received telbivudine
600 mg daily without vitamin D for 52 weeks (Historical controls,
GLOBE trial-NCT00057265). Creatine kinas (CK) was assessed by
standard biochemistry at various times during follow up. CK
Normal 7X ULN). Adverse
events were assessed by questionnaire. Myopathy was defined as
persistent unexplained muscle aches, pain, or weakness regardless
of the degree of increases in creatine kinas (CK) levels.
Results: All patients were with genotype D, and 56% were male.
Overall, after 1 year of follow up, 76% (23/30) of the treatment
group with vitamin D3 had normal CK, 23% (7/30) had grade 1–2 CK
elevation and none had grade 3–4 CK elevation as compared to 8%
with Grade1–2 CK elevation and 7.5% with Grade 3–4 CK elevation
in the historical controls group. The mean time to CPK elevation
was 40 weeks and ranges between 187–750 U/L. Mean vitamin D
serum level at week 40 was 41±30 (NL > 32 ng/ml). 2% of patients
in the treatment group had muscle pain as compared to 21% in
the historical control group and in a clinical setting (P < 0.001).
Myopathy was absent in the treatment group as compared to 1
patient in the historical controls.
Conclusion: Adding vitamin D to Telbivudine therapy for patients
with chronic HBV genotype D infection may significantly improves
muscle pain and prevent grade 3–4 CK elevation.