Background: Novel direct-acting agents (DAA) offer improved tolerability and sustained virologic responses (SVR) over prior interferon (IFN)-based therapies for Hepatitis C virus (HCV) infection. A recent study of HCV mono-infected patients identified DAA drug authorization as a barrier (time to approval from initial pre-authorization = 100 days; time to final approval = 117 days). However, there are no published data reporting barriers to care with DAA in those with HIV coinfection.
Methods: We conducted a retrospective review of adult HIV-infected patients with chronic HCV at Washington University Infectious Diseases Clinic to determine the proportion of patients offered DAA, the reasons for not being offered DAA, the time to approval of DAA and proportion of treated patients who achieved SVR. Mann-Whitney test was used to determine the factors associated with not being offered DAA. All patients with at least 1 visit between January 1, 2014 and December 31, 2015 were included in the analyses.
Results: Of the 103 patients, 74% were African American, 83% were males, 69% had suppressed HIV RNA, 55% had psychiatric illness, and 21% had active substance abuse. The majority of patients had genotype 1 (85.4%); 61.1% had some form of fibrosis staging performed; 26.2% were cirrhotic. Of the 49 patients who were offered DAA, 34 were approved as of December 31, 2015. 16 patients completed treatment, of whom 15 achieved SVR. Of the 54 (52.4%) patients who were not offered DAA, the most common reasons were substance abuse, psychiatric disease, and uncontrolled HIV. Those who were not offered DAA were likely to have: no insurance (0.0% vs 50.5%, p=0.028), substance abuse (9.1% vs 58.0%, p <0.001) and uncontrolled HIV (12.5% vs 63.4%, p< 0.001). Mean time to approval from initial pre-authorization was 10 days. Mean time to final approval (including appeal and patient assistance) was 16.9 days.
Conclusion: Despite effective DAAs, many coinfected patients may not be offered HCV treatment because of substance abuse, psychiatric disease, and uncontrolled HIV. Addressing these barriers to HCV treatment will increase the number of patients offered therapy and may improve real-world SVR with DAAs, especially as approval times in this population appear to be a less significant barrier than what has been reported.
S. Amornsawadwattana, None
A. Garavaglia-Wilson, None
R. Presti, None