Impact of coinfection with HIV-1 and GBVirus C in patients receiving a Ritonavir-Boosted HAART regimen : a substudy to the MaxCmin1 Trial

In 1995 the GB virus C (GBV-C) was identified. Although it is related to the hepatitis C virus, there are currently no persuasive data to suggest that this virus causes hepatitis or other illnesses in humans.It has repeatedly been reported that GBV-C viremia is associated with a more benign course of the natural history of HIV-1 infection, as has been found in most of the studies but not in all (as reviewed by Kaiser and Tillmann. Highly active antiretroviral therapy (HAART) has completely changed the course of HIV-1 disease, leading to both declining morbidity and mortality. A preliminary analysis indicated that the beneficial effect of GBV-C on HIV-1 infection is also seen during HAART, which again has been confirmed by some but not other groups.3 The MaxCmin1 trial evaluated the safety and efficacy of indinavir (IDV) and saquinavir (SAQ) both in combination with low-dose ritonavir (r) as part of HAART regimens in a heterogeneous HIV-1-infected population. The main study conclusions were that the study regimens had equal immunologic and virologic efficacy, but more treatment-limiting adverse events were observed in the IDV/r arm. This provided an opportunity within the context of a randomized controlled trial to assess the role of GBV-C on efficacy outcome measures.