Modafinil and armodafinil treatment for fatigue for HIV-positive patients with and without chronic hepatitis C.

Fatigue is prevalent among patients with hepatitis C virus (HCV) and with HIV/AIDS but there are no established fatigue treatments for either condition or their combination. We analysed data from three trials of modafinil or armodafinil for HIV-positive patients with fatigue, including 36 co-infected with HCV, to compare treatment response and safety parameters related to HCV status. One hundred and twenty patients received active drug and 70 were randomized to placebo. Fatigue response rate to modafinil/armodafinil was 100% for patients with HCV (18/18) and 73% (74/102) for patients without HCV. Placebo response rate was 28% (5/18) and 29% (15/52), respectively. Depressive symptoms improved only when energy improved. Viral load declined from baseline after 12 and 26 weeks of active medication. CD4 cell count did not change, nor did alanine transaminase and aspartate aminotransferase for patients with HCV. Patients with haematocrit below the reference range responded, as well as patients whose values were within the reference range. Modafinil and armodafinil appear effective and well tolerated for treating fatigue among both HCV-positive and HCV-negative patients with HIV/AIDS, suggesting that they may hold promise for HIV-positive patients considering alpha interferon/ribavirin treatment for HCV. Further investigation in a focused trial is warranted.

RCT Entities:   Population Interventions Outcomes