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Virologic Response and Reinfection Following HCV Treatment among Hospitalized People Who Inject Drugs: Follow-Up Data from the OPPORTUNI-C Trial.

Kristian Braathen MalmeKathrine Stene-JohansenIngvild KlundbyØystein BackeTarjei FoshaugMaria Helseth GreveCharlotte Meinich PihlAne-Kristine FinbråtenOlav DalgardHåvard Midgard
Published in: Viruses (2024)
Treatment of hepatitis C among people who inject drugs (PWID) may be complicated by loss to follow-up and reinfection. We aimed to evaluate sustained virologic response (SVR) and reinfection, and to validate complete pharmacy dispensation as a proxy for cure among PWID enrolled in a trial of opportunistic HCV treatment. Data were obtained by reviewing the electronic patient files and supplemented by outreach HCV RNA testing. Reinfection was defined based on clinical, behavioral, and virological data. Intention to treat SVR ≥ 4 within 2 years after enrolment was accomplished by 59 of 98 (60% [95% CI 50-70]) during intervention conditions (opportunistic treatment) and by 57 of 102 (56% [95% CI 46-66]) during control conditions (outpatient treatment). The time to end of treatment response (ETR) or SVR ≥ 4 was shorter among intervention participants (HR 1.55 [1.08-2.22]; p = 0.016). Of participants with complete dispensation, 132 of 145 (91%) achieved ETR or SVR > 4 (OR 12.7 [95% CI 4.3-37.8]; p < 0.001). Four cases of reinfection were identified (incidence 3.8/100 PY [95% CI 1.0-9.7]). Although SVR was similar, the time to virologic cure was shorter among intervention participants. Complete dispensation is a valid correlate for cure among individuals at risk of loss to follow-up. Reinfection following successful treatment remains a concern.
Keyphrases
  • randomized controlled trial
  • hepatitis c virus
  • clinical trial
  • hiv infected
  • combination therapy
  • study protocol
  • big data
  • phase iii
  • deep learning
  • artificial intelligence