Safety and effectiveness of raltegravir in patients with haemophilia and anti-HIV multidrug resistance.

Highly active antiretroviral therapy (HAART) of HIV+ patients with haemophilia poses specific questions on safety and effectiveness because of long-lasting HIV infection, multidrug resistance, concomitant chronic liver disease and bleeding risk. Raltegravir belongs to a new class of drugs that inhibits HIV integrase and is known to have a good effectiveness and safety profile. The aim of this study was to evaluate safety and effectiveness of HAART with raltegravir in patients with haemophilia. HIV+ patients with haemophilia treated with raltegravir for ≥ 6 months were included in this retrospective study. Safety criteria were: occurrence of any adverse event, unexpected blood test abnormalities and increased consumption of coagulation factors. Effectiveness criteria were: no disease progression, viral load <40 HIV-RNA copies mL(-1) and increased or stable CD3+ CD4+ cell count above 200 cells cmm(-1). Seven patients with HCV co-infection underwent treatment with raltegravir for a median of 20 months (min-max: 7-30). Before starting treatment with raltegravir, three patients had CD3+ CD4+ cell counts <200 cells cmm(-1). The median viral load was 7547 copies mL(-1) (min-max: <40-37,807). During treatment, no new sign of disease progression was observed. All patients showed suppression of viral replication (<40 HIV-RNA copies mL(-1)). CD3+ CD4+ cell counts showed a median increase of 152 cells cmm(-1) (min-max: 40-525). Two patients suffered from peripheral neuropathy, which was deemed as possibly associated with raltegravir. There was no evidence of increased bleeding frequency, modification of bleeding sites and lack of response to replacement therapy. Raltegravir-based HAART appeared to be effective and generally well-tolerated in patients with haemophilia, and it might represent a useful option in these patients.