COUNTY OF SAN MATEO

Inter-Departmental Correspondence

San Mateo Medical Center

DATE:

June 21, 2004

BOARD MEETING DATE:

July 6, 2004

TO:

Honorable Board of Supervisors

FROM:

Nancy J. Steiger, Chief Executive Officer

SUBJECT:

Acceptance of a Grant Award from Valeant Pharmaceutical International Administered through PharmaNet, LLC and Agreement with PharmaNet, LLC to Conduct a Research Study for Persons with Chronic Hepatitis C

Recommendation

Adopt a resolution accepting a grant from Valeant Pharmaceutical International administered through PharmaNet LLC and authorizing execution of an agreement with PharmaNet, LLC to conduct a research study for persons with Chronic Hepatitis C

Background

The Clinical Trials and Research Unit of the San Mateo Medical Center was established by the Health Services Agency in 2000 in order to provide a mechanism and infrastructure for the conduct of clinical treatment trials and medical or psychosocial research projects for the benefit of the residents of San Mateo County. A preliminary assessment by the unit staff identified Hepatitis C as a problem affecting many of the County’s patients with HIV. The Clinical Trials and Research Unit discovered that patients are not responding to the current drug treatments. This trial will evaluate patient’s response to this new drug treatment.

Discussion

In April 2004, Valeant Pharmaceutical International administered through PharmaNet, LLC contacted the Clinical Trials and Research Unit to participate in a Randomized, Double-Blinded Multi-Centered Study to compare the safety and efficacy of Viraminde to Ribavirin in Threatment-Naïve Patients with Chronic Hepatitis C. On April 22, 2004, PharmaNet, LLC notified the County that our site was selected to participate in the clinical trial. The County will receive $92,800 for fiscal year 2004-2006, if 20 patients are enrolled successfully into the study.

The primary purpose of this study is to assess the safety and effectiveness of 24 months treatment comparing the safety and efficacy of Viraminde to Ribavirin in Threatment-Naïve Patients with Chronic Hepatitis C.

Outcome Objectives

The following outcome objectives related to this project will be measured in 2004-2006 using an Evaluation Work Plan included in the grant proposal:

Outcome Measures

(at end of first year)

2004-2006

Objectives

Percentage of project client goal (20 persons) recruited and assessed for this study.

75%

Percentage of project client’s dosage comparisons completed for this study.

100%

Percentage of project clients with positive response to trial medications

25%

Vision Alignment

This agreement keeps the commitment to Ensure Basic Health and Safety for All and goal number 5: Provide residents access to healthcare and preventive care. The agreement contributes to this commitment by providing a mechanism for a study to compare the safety and efficacy of Viraminde to Ribavirin in Threatment-Naïve Patients with Chronic Hepatitis C.

Fiscal Impact

The term of this agreement is upon its execution by both parties until the objectives of the Study are accomplished.

This total amount of the award is $92,800. Any changes to the budget will be adjusted at the September revisions. Administrative oversight, technical assistance, and project monitoring will be provided by existing Clinical Trials and Research staff. There is no net county cost associated with this project.