Open Label Study to Evaluate Chronic Hepatitis C Treatment in Latino Subjects With and Without HIV Co-infection
Open Label Study to Evaluate Chronic Hepatitis C Treatment in Latino Subjects With and Without HIV Co-infection
-  Peginterferon alfa-2a has been approved by the U.S. Food and Drug Administration (FDA)
 to treat adults with chronic hepatitis C virus (HCV) infection with liver disease who
 have not been previously treated with interferon-alpha drugs (which improve immune
 system response to infection). Ribavirin has been approved by the FDA and is usually
 given in combination with interferon drugs such as peginterferon alfa-2a for treatment
 of chronic HCV.

 -  Recent research shows that Latino whites do not respond as well to treatment with
 peginterferon alfa-2a and ribavirin as non-Latino whites. Various factors such as
 excessive weight, gender, and insulin resistance were evaluated to explain this
 difference, but research suggests that underlying factors related to Latino or
 non-Latino background, possibly genetic and immune differences, may be affecting the
 response to HCV infection and treatment. However, more research is needed on the
 effectiveness of peginterferon and ribavirin in Latino subjects with HCV, and with
 combined and human immunodeficiency virus (HIV) co-infection.

 Objectives:

 - To evaluate the safety, effectiveness, and viral response of peginterferon alfa-2a and
 ribavirin therapy for chronic hepatitis C in Latino participants with and without HIV
 co-infection.

 This is an observational study. The observed treatment is received and managed through their
 primary care.
Hepatitis C is a major health problem affecting 100- 300 million individuals worldwide.
 Chronic hepatitis C virus (HCV) infection leads to cirrhosis in approximately 20% of subjects
 over a period of 1-20 years. Hepatitis C is now the most common indication for liver
 transplantation in the United States. infection occurs in one-third of all HIV-infected
 individuals, and the natural history among HIV-1 infected individuals demonstrates higher
 levels of HCV viremia, faster rates of progression and cirrhosis. There have been very few
 studies addressing the lower therapeutic response rates in minorities outside of African
 Americans. A recent study showed that Latino white subjects respond less effectively (34%)
 than non Latino white subjects (49%) given the same treatment even after adjusting for
 various important factors. As the current landscape for treatment of HCV changes, it would be
 important to evaluate factors responsible for therapeutic response in Latino patients.

 This is a study to address the genetic, epigenetic, and proteomic expression during therapy
 for chronic hepatitis C in Latino participants with and without HIV co-infection. One hundred
 Latino participants who have evidence of chronic hepatitis C with and without HIV who are
 receiving treatment for HCV will be enrolled. The results of this study will enable us to
 explore reasons for the differential therapeutic response rates with Hepatitis C treatment in
 Latino participants with and without HIV coinfection.
-  INCLUSION CRITERIA:

 A subject must satisfy all of the following criteria to be eligible to participate in this
 study:

 1. Latino ethnicity. Latino ethnic background will be defined as a geographic,
 historical, and cultural heritage shared among persons from Spanish-speaking countries
 in South and Central America, Mexico, and the Caribbean. Both parents and all
 grandparents of the participant have to be Latino, with Spanish as the primary
 language. Participants have to be white; native aboriginal Indians, Asians, and blacks
 will be excluded.

 2. Age greater than or equal to 18 years.

 3. Documentation of hepatitis C infection by demonstration of a positive test for
 hepatitis C antibody and HCV RNA level of greater than or equal to 2,000 IU/mL.

 4. Documentation of HIV-1 infection in the second group of co-infected participants by a
 licensed enzyme-linked immunosorbent assay and confirmed by a Western blot or by HIV
 polymerase chain reaction positive.

 5. Participants with HIV: CD4+ cell counts greater than or equal to 100 cells/mm(3) or
 CD4+ cell percentage greater than or equal to 14%.

 6. Ability to provide informed consent and willingness to comply with the study
 requirements, storage of blood samples and clinic policies.

 7. Participants must have a primary care physician managing medical problems.

 8. For HIV infected participants, care provided by a primary physician must be consistent
 with the current DHHS guidelines. For those on therapy, HAART will be provided by
 their physician.

 9. Willing to undergo genetic testing

 10. About to start HCV treatment (with or without direct acting agents DAAs)

 EXCLUSION CRITERIA:

 A subject will be ineligible to participate in this study if any of the following criteria
 are met:

 1. Unable to comply with research study visits

 2. Have any condition that the investigator considers a contraindication to study
 participation.

 3. Pregnant or breastfeeding women.

 4. Patients with poor venous access