Is the expanding paradigm shift toward HCV treatment in primary care effective? Or, should it be left to specialists? Two recent studies shed light.
Shifting HCV Treatment to PCPs. The current trend in the US is to shift HCV treatment to PCPs; telemedicine may enable treatment of patients in underserved areas. Project ECHO, which provided training to PCPs to improve access to HCV treatment in underserved areas, found SVR was similar for PCPs vs specialists.2 Two new studies sought to determine if similar programs could improve DAA access.
Study 1: PCPs vs Specialists at VA Hospital.3 A retrospective analysis sought to determine the outcome of PCPs vs specialists treating 377 HCV-infected US veterans with DAAs. Two educational sessions were conducted by hepatologists for PCPs on treating HCV with DAAs; PCPs had full pharmacy support for monitoring and dispensing DAAs. A total of 62 PCPs treated 185 noncirrhotic patients and 5 specialists treated 192 noncirrhotic patients.
Cure Rates Similar. Over 90% of patients in both groups achieved SVR 12 weeks after treatment with the majority of patients being genotype 1a. There were no significant differences between groups in SVR and post-treatment markers of disease severity. Majority of patients who achieved SVR were receiving ledipasvir/sofosbuvir only.
*MELD, Model for End-Stage Liver Disease; CTP, Child-Turcotte-Pugh
Clinical Implications. Guidelines are needed for referring noncomplex HCV patients to PCPs; multidisciplinary approach and PCP education is needed; pharmacists may improve treatment access and provide counseling. However, because it was a single center study, more studies are needed to confirm generalizability. Also, the specialists treated complex patients with more high-risk lifestyles, which could have biased results.
Study 2: HCV Treatment in IV Drug Users.4 In the first RCT of DAA initiation in HCV-infected PWID, researchers compared DAA uptake and treatment outcomes in primary care vs SOC in Australia or New Zealand. The HCV-infected PWID did not have cirrhosis, HIV, or HBV and were naÃ¯ve to DAAs. Out of the 136 participants, 70 were randomized to 13 primary care sites and 66 to SOC. Hepatitis nurses provided HCV treatment support for PCPs.
Cure Rates Higher for PCPs vs Specialists. The study found that DAA initiation was 2.5 times more likely with PCPs (75%) vs SOC (34%). More patients were lost to follow-up or exited the study when randomized to SOC (71%) vs PCPs (34%). PWID were 63% more likely to reach SVR12 with PCPs (49%) vs SOC (30%).
Clinical Implications. IV drug use drives HCV epidemic in high income countries; need increased access to DAAs in order to reach WHO HCV elimination targets. The current restrictions on DAA administration may need revision with just 20% of European countries who offer HCV treatment outside of the hospital and ~67% of the US restricts DAA prescribing by prescriber type.
1. Edlin BR, Eckhardt BJ, Shu MA, Holmberg SD, Swan T. Toward a more accurate estimate of the prevalence of hepatitis C in the United States. Hepatology. 2015;62:1353-1363.
2. Arora S, Thornton K, Murata G, et al. Outcomes of treatment for hepatitis C virus infection by primary care providers. N Engl J Med. 2011;364:2199-2207.
3. Syed TA, Bashir MH, Farooqui SM, et al. Treatment outcomes of hepatitis C-infected patients in specialty clinic vs. primary care physician clinic: A comparative analysis. Gastroenterol Res Pract. 2019;2019:8434602.
4. Wade AJ, Doyle JS, Gane E, et al. Outcomes of treatment for hepatitis C in primary care compared to hospital-based care: A randomised controlled trial in people who inject drugs [published online ahead of print (June 22, 2019)]. Clin Infect Dis. 2019. doi: 10.1093/cid/ciz546.
Direct-acting antivirals (DAAs) were introduced in 2013, and have been linked to >90% sustained viral response (SVR), or undetectable viral load, which is considered a cure. Up to 4.6 million people in the US may be infected with hepatitis C virus (HCV).1Â Yet only a small percentage have been treated with DAAs since their introduction. Treatment of HCV usually occurs in the specialist setting, but primary care physicians (PCPs) offer a way to expand treatment with less loss to follow-up. Two new studies suggest using DAAs to treat patients with uncomplicated HCV is equally effective when provided by PCPs or specialists.