Hepatitis C is an inflammation of the liver caused by infection with the hepatitis C virus (HCV). HCV is a major cause of liver disease in the US and progresses more rapidly to liver damage in HIV-infected persons. The virus lives in the blood and is spread by contact with this infected blood through shared needles, sexual contact, or from an infected mother to a baby during delivery.
It is estimated that 30% of persons with HIV in the United States (US) are co-infected with HCV. Risk factors of dual infection include accelerated hepatitis C disease progression, increased risk for liver disease, liver failure, and liver related death, and increased risk of transmission for hepatitis C. There is no vaccine for hepatitis C but persons infected with hepatitis C should be vaccinated to prevent hepatitis A and hepatitis B. Hepatitis C treatments can cure HCV. HCV treatments are improving by causing fewer side effects and having shorter treatment lengths.
Clients that are enrolled in one of the insurance programs through VA ADAP have access to HCV medications if they are available on their insurance plans formulary. VA ADAP will pay for the medication co-pay/cost share. If HCV medications are not available on the insurance plan formulary or the medication request is denied, clients can access Harvoni, Sovaldi, Daklinza, Zepatier, Epclusa and Viekira Pak through the treatment assistance program. VA ADAP will continue to be the payer of last resort and will continue to provide Ryan White services not covered by public or private health insurance plans.
The Virginia Department of Health (VDH) provides a treatment assistance program for HCV/HIV co-infected AIDS Drug Assistance Program (ADAP) clients. The program provides Harvoni, Sovaldi, Daklinza, Viekira Pak, Zepatier, Epclusa, and if needed, ribavirin, and payments for associated medical care and labs for uninsured clients or those whose insurance does not cover those medications.
The application process is initiated by the client’s medical provider. All questions on the application must be completed, required documents much be attached, and the form must be signed by the client’s medical provider applying for this assistance. Applications are reviewed by a clinical review team to ensure client is accessing the correct medication.
Medications are shipped to the medical provider’s site. In order for these medications to be shipped to the medical provider’s site, a Controlled Substance Registration (CSR) must be established. Please contact Stephanie Wheawill, Director of Pharmacy Services, at 804-786-7326, to obtain the necessary documents. Medications may also be shipped to the client’s Local Health Department of choice. Services provided through VA ADAP’s HCV/HIV Treatment Assistance Program are dependent upon available funding.
Must be ADAP eligible
- At least 6 months undetectable HIV viral load
Lab results must be submitted to VDH
- By provider report, client has chronic Hepatitis C infection with at least one positive HCV RNA quantitative assay within the last 6 months.
- HCV Genotype:
Harvoni is effective in treating Genotype 1 or 4
Sovaldi is effective in treating Genotype 2 or 3
Daklinza is effective in treating Genotype 3
Zepatier is effective in treating Genotype 1 or 4
Epclusa is effective in treating Genotype 1-6
Viekira Pak is effective in treating Genotype 1 or 4
- On stable antiretroviral (ARV) therapy regimen for at least 6 months (by provider report)
- Strongly adherent to medical care (by provider report)
- Uninsured or Previous denial for treatment documented by insurance plan
As a result of extensive clinical review, the following treatment guidelines have been established:
|Patient Population||Recommended Treatment Duration|
|Treatment-naïve with or without cirrhosis||12 Weeks|
|Treatment-experienced* without cirrhosis||12 Weeks|
|Treatment-experienced* with cirrhosis||12 Weeks with the addition of ribavirin **|
|Treatment-experienced* with cirrhosis||24 Weeks|
*Treatment-experienced patients who have failed treatment with either peginterferon alfa + ribavirin or an HCV protease inhibitor + peginterferon alfa + ribavirin.
**If ribavirin is indicated, Virginia (VA) ADAP will also provide that medication.
Recommended Treatment Protocol* (Guidelines only, defer to provider for evaluations and labs):
* Office visits and laboratory studies covered by VA ADAP
|TIME INTO HEPATITIS C TREATMENT||
CLINIC VISITS & LABORATORY TEST
|Baseline – Initiation of Treatment||Clinic Visit, HCV RNA assay, (if not done in past 3 months), Comprehensive Metabolic Panel (CMP), complete blood count (CBC), INR|
|2 Weeks||HCV RNA assay, CMP|
|4 Weeks||Clinic Visit, Viral load, CMP, CBC|
|8 Weeks||Clinic Visit, CMP (Optional: Not necessary if doing well at week 4)|
|12 Weeks – End of Treatment||Clinic Visit, HCV RNA assay, CMP, CBC|
|16 Weeks (If 24 week treatment)||CMP, CBC (Optional)|
|20 Weeks (If 24 week treatment)||CMP, CBC (Optional)|
|24 Weeks – End of Treatment (If 24 week treatment)||Clinic Visit, HCV RNA assay, CMP, CBC|
|4 Weeks after End of Treatment||HCV RNA assay, CMP|
|12 Weeks after End of Treatment||Clinic Visit, HCV RNA assay, CMP, CBC|
Click here for additional information about HCV Medication Patient Assistance Programs (PAPs)