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Sustained Virologic Response Possible for HCV Drug Users With Patient-Centered Programs

The mean daily adherence was higher in the mDOT group compared to the patient navigation group.

Implementing patient-centered programs for people who inject drugs (PWID) who are diagnosed with hepatitis C virus (HCV) could help bring up the rates of sustained virologic response (SVR).

A team, led by Alain H. Litwin, MD, MPH, Department of Medicine, Prisma Health, compared 2 patient-centered models of HCV care of people who inject drugs with active drug use.

The Problem

An increased uptake of treatment for individuals who inject drugs is needed in order to achieve World Health Organization targets for eliminating HCV as a public health threat.

However, 1 issue preventing this is that optimal HCV co-located treatment models for people who inject drugs has not yet been identified.

In the pragmatic, randomized, controlled trials, the investigators examined patients at 8 US cities in 8 opioid treatment programs and 15 community health centers. Included in the study were people who inject drugs who were actively injecting within 90 days of the study entry period.

The Programs

Each participant was randomly assigned to either patient navigation or modified directly observed therapy (mDOT) using computer-generated variable block sizes of 2-6 stratified by city, clinical settings, and cirrhosis status.

Each participant received a fixed-dose combination tablet of sofosbuvir 400 mg with velpatasvir 100 mg orally once daily for 12 weeks.

The investigators sought a primary outcome of sustained virological response determined by chart review between 70-365 days after the end of treatment and if unavailable study blood draws. They also sought secondary outcomes of treatment initiation, adherence, measured by electronic blister packs, and treatment completion.

The patients were split between the modified intention-to-treat (mITT; all who initiated treatment), intention-to-treat (all who were randomized), and per-protocol populations.

Results

Overall, 1891 individuals were screened between Sept 15, 2016 and Aug. 14, 2018. However, 1136 participants were excluded when 213 declined to participate and 923 did not meet the eligibility criteria. The remaining 755 participants were assigned to patient navigation (n = 379) or mDOT (n = 376).

For the mITT sample of 623 patients who were randomized and initiated treatment, 74% (n = 226) (95% CI, 69-79) of participants in the mDOT group and 76% (n = 236) (95% CI, 69-79) of the patient navigation group had an SVR, with no significant difference between the groups (aOR, 0.97; 95% CI, 0.66-1.42; P = 0.35).

For the ITT sample of 755 patients, 60% (n = 226) (95% CI, 55-65) of participants in the mDOT group and 62% (n = 235) (95% CI, 57-67) of participants in the patient navigation group had an SVR (aOR, 0.92; 95% CI, 0.68-1.25; P = 0.44). In the per-protocol sample of 501 patients, 91% (n = 226)) (95% CI, 87-94) in the mDOT group and 93% (n = 235) (95% CI, 89-96) of the patient navigation group had an SVR (aOR, 0.79l 95% CI, 0.41-1.55; P = 0.44).

A total of 306 (81%) of participants in the mDOT group and 317 (84%) participants in the patient navigation group initiated treatment (aOR, 0.86; 95% CI, 0.58–1.26]; P = 0.44). Among this group, 251 (82%) participants in the mDOT group and 264 (83%) participants in the patient navigation group completed treatment (aOR, 0.90; 95% CI, 0.58–1.39]; P = 0.63).

The mean daily adherence was higher in the mDOT group (78%; 95% CI, 75–81) compared to the patient navigation group (73%; 95% CI, 70–77), with a difference of 4.7% [95% CI, 1.9–7.4]; P = 0.0010).

In the safety analysis, the investigators observed 421 serious adverse events, 217 in the mDOT group and 204 in the patient navigation group. The most common serious adverse event was hospital admission, with 176 in the mDOT group and 161 in the patient navigation group.

“In this trial of active PWID, both models resulted in high SVR. Although adherence was significantly higher in the mDOT group versus the patient navigation group, there was no significant difference in SVR between the groups. Increases in adherence and treatment completion were associated with an increased likelihood of SVR,” the authors wrote. “These results suggest that active PWID can reach high SVRs in diverse settings with either mDOT or patient navigation support.”

The study, “Patient-centered models of hepatitis C treatment for people who inject drugs: a multicenter, pragmatic randomized trial,” was published online in The Lancet Gastroenterology & Hepatology.