A PILOT STUDY OF SILYMARIN IN PATIENTS WITH HIV AND HCV

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. It is well-known that HIV infection is a major cause of morbidity and mortality worldwide. In the developed countries, there have been major advances in the treatment of HIV infection in recent years and most patients are treated with HAART, with significant improvement in symptoms, reduced incidence of opportunistic infections and prolongation of survival, albeit at a high cost, both in dollars and in treatment-associated side effects. Since HCV is also transmitted by blood and body fluids, HCV-coinfection is very common in HIV, with most surveys finding that 40-75% of patients with HIV also have HCV. As treatment and prophylaxis have improved for many opportunistic diseases, HCV is emerging as an increasing problem. HCV co-infection has been shown to affect the progression of HIV, and end-stage liver disease is becoming a common cause of death in patients with HIV. Treatment for HCV has also improved in recent years, but remains expensive, toxic and at best partially effective. In addition, the complexity of most HAART regimens makes the addition of HCV therapy doubly daunting for both patients and providers. Current recommendations for treating HCV in co-infected patients suggest treating for HCV before patients meet criteria for HAART. However, in practice, particularly in poorer inner-city areas, HIV infection is often diagnosed when patients' disease is advanced, and HAART therapy becomes a priority. Since HAART is often hepatotoxic, many providers are reluctant to further complicate matters by adding more drugs, and HCV is often untreated. In fact in our clinic, where 40% of patients with HIV have HCV-coinfection, less than 10% are currently treated for both. The objective of this project is to assess the feasibility of investigating the effect of silymarin, derived from the milk thistle plant, Silybum maranum (L.) Gaertn. in preventing or reversing the complications of chronic infection with hepatitis C virus in patients with HIV, to serve as the basis of a more definitive study. Allopathic therapeutic interventions for HCV are expensive and poorly tolerated, particularly with the genotype most commonly encountered in the US. There are limited rigorous assessments of the dietary supplement milk thistle, but there is suggestion of benefit and much interest on the part of coinfected patients and their providers. Hypothesis: Subjects co-infected with HIV and HCV who receive milk thistle in combination with Highly Active Antiretroviral Therapy (HAART) will experience improvement in symptoms of HCV and HIV. Milk thistle will be tolerated and efficacious in this population of patients.