Review Article

PBC: Animal Models of Cholangiopathies and Possible Endogenous Viral Infections

Table 2

Antiviral trials for PBC.

TrialMethodSubjectDesignPrimary outcomeYearReference

Pilot studies of single and combination antiretroviral therapyLamivudine + Zidovu- dine versus LamivudineHumanRandomized controlled trial (RCT)Serological improvements of alkaline phos-phatase, AST and ALT. Histological improvement in necroinflammatory score and a reduction in bile duct injury.2004[43]
Clinical trial: randomized controlled trial of lamivudine and zidovudine (Combivir)Lamivudine + Zidovu- dine + UDCA versus UDCAHumanRCTSerological improvements in serial alkaline phosphatase, ALT and AST.2008[44]
Randomized controlled trial of lamivudineLamivudine versus UDCAHumanRCTOne case showed a decrease of AMA titers.2010[45]
Combination antiretroviral therapy with CombivirLamivudine + Zidovu- dine versus PlaceboNOD.c3c4 mouseHistological improvement in necroinflammatory score and a reduction in bile duct injury. No improvement on bile duct cyst. Decrease in viral burden.2007[46]
Highly active antiretroviral therapy with reverse trans- criptase inhibitors and protease inhibitorCombination of reverse transcriptase and protease inhibitorNOD.c3c4 mouseSerological improvements in alkaline phos-phatase and AST. Complete disappearance of cholangitis.2008[47]