Table 2.
Antiviral trials for PBC.
Trial | Method | Subject | Design | Primary outcome | Year | Reference |
---|---|---|---|---|---|---|
Pilot studies of single and combination antiretroviral therapy | Lamivudine + Zidovu- dine versus Lamivudine | Human | Randomized 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 UDCA | Human | RCT | Serological improvements in serial alkaline phosphatase, ALT and AST. | 2008 | [44] |
Randomized controlled trial of lamivudine | Lamivudine versus UDCA | Human | RCT | One case showed a decrease of AMA titers. | 2010 | [45] |
Combination antiretroviral therapy with Combivir | Lamivudine + Zidovu- dine versus Placebo | NOD.c3c4 mouse | Histological 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 inhibitor | Combination of reverse transcriptase and protease inhibitor | NOD.c3c4 mouse | Serological improvements in alkaline phos-phatase and AST. Complete disappearance of cholangitis. | 2008 | [47] |