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New therapeutic option for decreasing ART- related toxicity in HIV/HCV coinfected patients

R. Chehitiani1, B. Pylypchuk2, E. Zagaydanova1, O. Ordzanova3, L. Urchenko3 1State Medical University , AIDS- center, Luhansk, Ukraine; 2Scientist association , Ekomed, Kiev, Ukraine; 3 Tuberculosis hospital, Pulmonal tuberculosis, Lisichansk, Ukraine

   Background: Hepatic toxicity greatly complicates the management of HIV treatment - experienced patients. In several large trials of HIV/HCV co-infected patients, more participants stopped their assigned therapy due to toxicity than virological failure. In the Ukraine, most HIV -infected patients have few antiretroviral options due to limited resources. Significant metabolic disorders and underlying hepatic injury caused by chronic alcohol, drug addiction and hepatitis co-infection are common. Preliminary results of the immunomodulating agent Dzherelosuggested hepatic anti-inflammatory activity. We hypothesized that the addition of Dzherelo may attenuate hepatic toxicity in patients receiving antiretroviral therapy (ART). Methods: We report the 24-week results of an ongoing study initiated March 2005. 35 HIV/HCV co-infected patients suffering from alcohol abuse or/and drug addict were enrolled. ART including AZT/3TC/NVP was initiated. Dzherelo was added to the therapy a median of 8-10 weeks after starting ART. ART- related hepatotoxicity was defined as an increase in ALT/AST levels up to five times the upper limit of normal, or 3,5 fold increase if baseline level was abnormal.
Results: 25/35 (71%) patients had baseline elevations in liver function tests (LFT) Mean baseline values were AST - 49 U/L , ALT - 62 U/L before starting ART. At week 8, prior to starting dzherelo, LFT has increased to niean ALT -109 U/L, mean AST- 47 U/L. The number of patients with protocol-defined ART related hepatotoxicity was 6/35 (18 %). Among them 3 died and one refused further therapy due gastrointestinal disorders. ART therapy needed to be interrupted and therapy changed in 2 patients due to hepatotoxicity. After dzherelo was added to the treatment regimen, LFT values declined to mean ALT- 43U/L, mean AST- 45 U/L and hepatotoxicity was not seen in any patients at week 24. No new cases of hepatotoxicity were reported after starting Dzhereloand no clinical signs of hepatic inflammation were seen. Bilirubin levels were in the normal range at week 24.
Conclusions: Dzherelo appeared to attenuate hepatotoxicity from ART (NRTI + NNRTI) in this population with underlying liver pathology. This may lead to improved hepatotoxicity and reduced toxicity related therapy interruptions. Further study of this agent in this role is merited.

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