High Rates of Sustained Virological Response in People Who Inject Drugs Treated with Sofosbuvir-Based Regimens

Author: Alain H. Litwin, Kim K. Yu, Jordan Wong, Irene J. Soloway, Linda Agyemang, Brianna L. Norton, Moonseong Heo, Julia H. Arnsten

Theme: Clinical Research Year: 2015

Background: The majority of existing and new cases of HCV in the United States occur among people who inject drugs (PWID). Many PWID including those on opiate agonist treatment (OAT) are denied potentially life-saving HCV treatment. Treatment of patients with sofosbuvir (SOF) – based regimens is associated with high rates of SVR in genotype 1 – 4 patients enrolled in registration trials, but these trials excluded active PWID.

Methods: RISE is a prospective study that enrolled PWID with chronic HCV genotypes (G) 1 – 4 on OAT including those actively using drugs. Patients received sofosbuvir-based regimens according to AASLD/IDSA guidelines (G1/3/4: SOF/PEG/RBV x 12 weeks and SOF/RBV x 24 weeks; G2: SOF/RBV x 12 weeks). Rates of SVR12 were measured. Adherence was measured via electronic weekly blister packs and visual analogue scales (VAS), and drug use was assessed through urine screens.

Results: Patient characteristics (n=61) include: mean age 52; male, 61%; Latino, 59%; African-American, 21%; cirrhotic, 23%; HIV-infected, 15%; G1 (n=23); G2 (n=16); G3 (n=21); and G4 (n=1). SVR12 results were available for 51 patients: G1 – SOF/PEG/RBV (n=7; SVR=100%), G1 – SOF/RBV (n=16; SVR=75%), G2 (n=14; SVR=79%), G3 (n=13; SVR=92%), G4 – SOF/RBV (n=1; SVR=0%). Ten remain on or recently completed treatment. There was no change in proportion of patients who used illicit drugs 6 months prior to treatment versus during treatment: any drug (63% v. 63%), other opiates (49% v. 39%), cocaine (23% v. 24%), and benzodiazEpidemiology & Public Health Researchnes (30% v. 24%). Mean adherence by monitors was 74% (daily time frame) and 88% (weekly time frame); mean adherence by VAS was 95%; 2 patients discontinued treatment.

Conclusion: This study demonstrates that a high proportion of PWID completed therapy with high rates of SVR despite significant rates of drug use and marginal adherence rates. This data demonstrates support for the treatment of PWID.

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