Topic Suggestion Description

Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

The key questions for this report focus on the relationship between adherence to treatment and outcomes of treatment, predictors of poor treatment response, and appropriate treatment intervals based on genotype. 1. Is there an association between adherence to treatment (pegylated interferon and/or ribavirin) for chronic hepatitis C and treatment outcomes (e.g., cirrhosis, hepatocellular carcinoma, death, early viral response [EVR], sustained viral response [SVR])? 2. Are there other predictors of treatment outcomes? 3. What guidance is available from technology assessments and guidelines for treatment length and monitoring of patients with chronic hepatitis C in the following subgroups: - genotypes 2 and 3 (more responsive to treatment) - genotypes 1 an 4 (less responsive to treatment) - treatment naïve patients with chronic hepatitis C - patients who are not responsive to initial treatment, especially if initial treatment is with pegylated interferon and ribavirin? - patients who relapse after initial response, especially if initial treatment is with pegylated interferon and ribavirin? Inclusion Criteria (Patients, Intervention, Comparator, Outcomes or PICO): Patient group/population: ? Adults (> 18 years old) with chronic hepatitis C (treatment naïve, treatment non-responders, relapse after successful treatment), all genotypes and varying treatment groups (treatment naïve, treatment non-responders, relapsers) Intervention(s): ? Pegylated interferon (or interferon) and ribavirin with varying levels of treatment adherence (KQ 1) ? Pegylated interferon and ribavirin for 48 weeks for genotypes 1 and 4 (KQ 2 and 3) ? Pegylated interferon and ribavirin for 24 weeks for genotypes 2 and 3 (KQ 2 and 3) Comparator(s): ? Good adherence (> 80% adherence) to treatment (KQ 1) Outcome(s): ? Viral response at 12 (EVR), 24, and 48 weeks, SVR, cirrhosis, hepatocellular carcinoma, death (KQ 1 – 3)

Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)

no

If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:

What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)

Also See Question 1 Adults (> 18 years old) with chronic hepatitis C (treatment naïve, treatment non-responders, relapse after successful treatment), all genotypes and varying treatment groups (treatment naïve, treatment non-responders, relapsers)

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

See Above

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

Viral response and sustained viral response.

Describe any health-related risks, side effects, or harms that you are concerned about.

Cirrhosis, hepatocellular carcinoma and death

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

• Infectious diseases, including HIV/AIDS

AHRQ Priority Populations

• Low income groups
• Minority groups
• Women

Federal Health Care Program

• Medicaid

Importance

Describe why this topic is important.

Hepatitis C is the most common chronic blood borne infection in the United States affecting approximately 3.2 million people ("Hepatitis C (Information for Health Professionals) "). Treatment of chronic hepatitis C is costly and has high rates of adverse events resulting in reduced dosing and poor adherence to treatment. For combination therapy with PEG-IFN and RBV, costs are estimated at $327 to $380 per week based on Veterans Affairs costs in 2002 (Smith & Hassan, 2005), which are likely less than the costs of these drugs for Medicaid programs. Using the mid-point value of $354 per week, 48 weeks of treatment cost $16,992. In Canada, the estimated cost of 48 weeks of treatment is $20,000 (C$) (Brady et al., 2007), and a recent estimate from the Arkansas Medicaid program is $35,000. Unfortunately, medication side effects and adverse events lead to treatment discontinuation in about 10% - 15% of patients or a dose reduction in another 18% - 20% of patients (Smith & Hassan, 2005). Adverse events include flu-like illness, depression, alopecia, anemia (including hemolytic anemia), neutropenia, thrombocytopenia, hypothyroidism, and teratogenic risk (for RBV).

What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)

We are working with state Medicaid policy makers to address their needs to develop policy coverage decisions around poor adherence to HEP C treatment protocols.

Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)

yes

If yes, please explain:

At what point do you discontinue HEP C treatment when patients are not adhering, or responding to, the treatment protocol.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

See #10. Additionally it will provide information on how to design the HEP C treatment and management program based on the available evidence.

Describe the timeframe in which an answer to your question is needed.

1-2 years, one year ideal.

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

Low-income and minority populations are particularly impacted with this infectious disease.

Nominator Information

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)

• Public Policy-Maker/Legislator
• Health Care Payer/Purchaser (Employer, Federal Government)
• Other

Are you making a suggestion as an individual or on behalf of an organization?

Organization