Decentralized HCV Treatment is Effective!

Posted on October 18, 2015

Given the safety, tolerability, simplicity, and efficacy of hepatitis C direct-acting antiviral (DAA) regimens, decentralizing treatment from gastroenterologists and hepatologists to other specialists, community-based primary care physicians, or appropriately supervised mid-level providers (ie, task-shifting) may be an effective strategy to increase treatment rates, cure rates, and really start addressing to the HCV epidemic. The SVR-12 rates achieved by a US rural outreach program based on the task-shifting model—88 % overall, 86 % in genotype 1 patients, 94 % in genotype 2 patients, and 83 % in genotype 3 patients—are comparable to those achieved in phase II and III clinical trials utilizing these regimens. By utilizing task-shifting, wherein a local mid-level provider monitored patients on DAA treatment with indirect supervision of a specialist, high rates of treatment adherence and success in medically underserved areas was achieved.

Facts

Nationally, only 32–38 % of patients diagnosed with HCV receive any subsequent HCV-related care, and a mere 13–18 % receive treatment. These significant drop-offs in each step of the continuum of HCV care are likely more pronounced in medically underserved areas.

  • Fewer than half of patients with HCV are estimated to be aware of their infection
  • Awareness of screening guidelines among providers is insufficient
  • Insurance may not readily cover the cost of medication
  • HCV treatment has historically been the remit of specialists and urban referral medical centers

 

Little attention has been paid to the issue of access to novel, direct-acting antiviral (DAA) regimens in medically underserved areas in the US. Patient inconvenience, cost, and treatment delays may result from channeling patients from medically underserved areas into referral medical centers or to gastroenterologists, hepatologists, and other specialist providers for treatment. Given the safety, tolerability, simplicity, and efficacy of DAA regimens, decentralizing treatment from gastroenterologists and hepatologists to other specialists, community-based primary care physicians, or appropriately supervised mid-level providers (task shifting) may be an alternative strategy. The success of a decentralized, US rural outreach treatment model utilizing the concept of task shifting to help overcome HCV treatment access barriers in medically underserved areas, was discussed in a recent article in the journal Digestive Diseases and Sciences (Jayasekera CR, et al. Dig Dis Sci. 2015 Oct 14. [Epub ahead of print]).

Between December 2013 and November 2014, 58 consecutive HCV-infected patients received HCV treatment at three clinics in San Luis Obispo, Santa Maria, and Templeton, California, in federally designated medically underserved areas.

  • The clinics are supported by a part-time licensed vocational nurse with approximately 16 years of experience in supporting the treatment of patients with chronic liver diseases including HCV.
  • A hepatologist from an academic medical center (AA), visiting approximately bimonthly, assesses patients with liver disease referred by local physicians. The hepatologist contacts patients by telephone with clinical recommendations in the event of laboratory abnormalities and remains available to patients and the licensed vocational nurse by telephone and secure messaging through the electronic medical record.
    • When directed by a clinical need, patients are scheduled for evaluation by the hepatologist at the next outreach clinic date, or referred to local urgent care or emergency rooms as needed
  • Patients with HCV who are prescribed DAA-based treatment meet with the licensed vocational nurse on a monthly basis for assessment of adverse events, treatment intolerance, and verbal assessment of medication adherence
    • Decisions regarding DAA-based treatment eligibility are made on a case-by-case basis
    • Treatment regimens followed the prevailing guidelines of the American Association for Study of Liver Diseases and the Infectious Diseases Society of America at the time of treatment
    • The hepatologist assesses all patients in outreach clinic 12 weeks after completion of treatment to determine virologic cure (sustained virologic response-12 or SVR-12)

Average age of the 58 patients in this study was 62 years (range 46–92 years), and 36 % were female

  • 50 % were cirrhotic
  • 12 % had previously undergone liver transplantation
  • Almost 60 % had previously not responded to interferon-based treatment

The curative endpoint, SVR-12, was 88 % overall, 85 % in patients with prior HCV treatment experience, and 79 % in patients with cirrhosis. The SVR-12 rates achieved—88 % overall, 86 % in genotype 1 patients, 94 % in genotype 2 patients, and 83 % in genotype 3 patients—are comparable to those achieved in phase II and III clinical trials utilizing these regimens.

  • No statistically significant differences between SVR- 12 rates with SOF + SMV or SOF + RBV regimens, or in patients who were less than 65 years of age or older than 65 years of age
  • Cirrhotic patients had a lower SVR-12 rate than non-cirrhotic patients, but this was not statistically significant (P = 0.102)

56 patients completed treatment and 5 patients requested on-treatment clinic visits with the hepatologist during treatment for complaints of fatigue and anxiety, but no medication changes were instituted. No patients received blood products or growth factors, and there were no hospitalizations or deaths. By utilizing task-shifting, wherein a local mid-level provider monitored patients on DAA treatment with indirect supervision of a specialist, high rates of treatment adherence and success in medically underserved areas in California was achieved.

The authors concluded the following: “Inefficient utilization of healthcare human resources hinders efforts to control the HCV epidemic in the USA. Together with expanded HCV screening, judicious task-shifting of DAA-based treatment to a broad range of non-specialist providers—particularly in medically underserved areas—may constitute part of the solution. Comprehensive studies on the safety, effectiveness, and cost savings of such decentralized treatment models are needed before widespread application can be recommended.”


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