Examination of Fiscal Management and the Allocation of Care Act Resources US Department of Health and Human Services: Health REsources and Services Administration
INTRODUCTION
HIV/HCV Coinfection
HCV Treatment
Expanding Access to Treatment
Barriers and Key Issues
HCV Treatment: Estimating the Cost
Working With Patients Who Have Multiple Needs
Concerns About Relapse to Active Drug Use and Reinfection
Depression and HCV Treatment
Treatment Eligibility and Uptake
Treating Anemia and Neutropenia With Growth Factors
Access to HCV Treatment and ADAPs
Conclusion
Resources
References

Treatment Eligibility and Uptake

According to Practice Guidelines: Diagnosis, Management and Treatment of Hepatitis C, from the American Association for the Study of Liver Diseases (AASLD), the “characteristics of persons for whom therapy is currently contraindicated” are as follows:

  • Major, uncontrolled depressive illness
  • Renal, heart, or lung transplantation recipient
  • Autoimmune hepatitis or other condition known to be exacerbated by interferon and ribavirin
  • Untreated hyperthyroidism
  • Pregnancy or inability or unwillingness to comply with adequate contraception
  • Severe concurrent disease, such as severe hypertension, heart failure, significant coronary artery disease, poorly controlled diabetes, or obstructive pulmonary disease
  • Age younger than 3 years old
  • Known hypersensitivity to drugs used to treat HCV.44p1155

Providers should note that alcohol and drug use are not on this list. Many providers establish their own eligibility criteria, which may or may not reflect treatment guidelines. Some do not treat active drug or alcohol users, whereas others have used adherence to medical appointments as an alternative criterion for active users.56,74,111

Fleming and colleagues assessed HCV treatment eligibility in a cohort of 274 HIV/HCV-coinfected patients at an inner-city coinfection clinic. Only 33 (12 percent) were eligible for treatment. Reasons for treatment ineligibility included the following issues:

  • Nonadherence to clinic visits*
  • Active psychiatric disease*
  • Ongoing injection drug or alcohol use*
  • Advanced HIV disease*
  • Decompensated liver disease
  • Comorbid conditions (refractory anemia, renal or cardiac disease).

Only 21 of the 33 eligible patients initiated HCV treatment; 9 of the 21 patients prematurely discontinued their treatment due to acute psychiatric illness (n=4), medical complication (n=4), or loss to follow-up (n=1). Four patients were on HCV treatment when the paper was written. Ultimately, of the eight patients who have completed treatment, only two achieved SVR.55

In a study of treatment uptake among HCV mono- and coinfected veterans, Bini and colleagues found that only 69 percent of coinfected patients who were eligible for HCV treatment agreed to initiate treatment. The main reasons for treatment refusal were worries about potential side effects of current therapy and desire to postpone treatment until better options are available.159

Rauch and colleagues assessed eligibility for HCV treatment among 107 coinfected patients in the Swiss HIV Cohort Study, using the following exclusion criteria:

  • CD4 cell count of less than 250/mm3
  • Anemia (hemoglobin level less than 11 g/dL)
  • Cytopenia (neutrophil levels of less than 1.5.109 cells/L or a platelet count of less than 70.109 cells/L)
  • Liver diseases other than hepatitis C
  • Decompensated liver disease
  • Significant comorbidities (e.g., psychiatric disorders, seizures, cardiopulmonary disease, immunologically mediated diseases)
  • Uncontrolled addiction (illicit drug abuse or alcohol consumption of more than 40 g/day)
  • Pregnancy
  • Poor adherence to prescribed drugs (according to the physician).

Of the 107 patients, a total of 82 (77 percent) were ineligible for HCV treatment; most (73 percent) had more than one ineligibility criterion, and 33 percent had more than three. Of the 25 eligible candidates, 16 refused treatment because of fear of side effects and concern about the duration of HCV therapy, and 4 with HCV genotype 1 declined treatment because they had mild fibrosis. Only nine patients started HCV treatment.160

* Does not reflect AASLD treatment guidelines.
 
<< Depression and HCV Treatment • Treating Anemia and Neutropenia With Growth Factors >>