AI Article Synopsis
- A study was conducted to evaluate the effectiveness of elbasvir-grazoprevir in treating Hepatitis C virus (HCV) infection among people who inject drugs (PWID) who are also in opioid agonist therapy (OAT).
- The trial involved 301 patients and found high rates of sustained virologic response (SVR12) at 91.5% for those who received immediate treatment and 89.5% for those who had delayed treatment, showing that drug use did not negatively impact treatment adherence.
- The results may not apply to all PWID populations, particularly those not receiving OAT or those with genotype 3 HCV infection, but suggest that elbas
Article Abstract
Background: Hepatitis C virus (HCV) infection is common in persons who inject drugs (PWID).
Objective: To evaluate elbasvir-grazoprevir in treating HCV infection in PWID.
Design: Randomized, placebo-controlled, double-blind trial. (ClinicalTrials.gov: NCT02105688).
Setting: Australia, Canada, France, Germany, Israel, the Netherlands, New Zealand, Norway, Spain, Taiwan, the United Kingdom, and the United States.
Patients: 301 treatment-naive patients with chronic HCV genotype 1, 4, or 6 infection who were at least 80% adherent to visits for opioid agonist therapy (OAT).
Intervention: The immediate-treatment group (ITG) received elbasvir-grazoprevir for 12 weeks; the deferred-treatment group (DTG) received placebo for 12 weeks, no treatment for 4 weeks, then open-label elbasvir-grazoprevir for 12 weeks.
Measurements: The primary outcome was sustained virologic response at 12 weeks (SVR12), evaluated separately in the ITG and DTG. Other outcomes included SVR24, viral recurrence or reinfection, and adverse events.
Results: The SVR12 was 91.5% (95% CI, 86.8% to 95.0%) in the ITG and 89.5% (95% CI, 81.5% to 94.8%) in the active phase of the DTG. Drug use at baseline and during treatment did not affect SVR12 or adherence to HCV therapy. Among 18 patients with posttreatment viral recurrence through 24-week follow-up, 6 had probable reinfection. If the probable reinfections were assumed to be responses, SVR12 was 94.0% (CI, 89.8% to 96.9%) in the ITG. One patient in the ITG (1 of 201) and 1 in the placebo-phase DTG (1 of 100) discontinued treatment because of an adverse event.
Limitation: These findings may not be generalizable to PWID who are not receiving OAT, nor do they apply to persons with genotype 3 infection, a common strain in PWID.
Conclusion: Patients with HCV infection who were receiving OAT and treated with elbasvir-grazoprevir had high rates of SVR12, regardless of ongoing drug use. These results support the removal of drug use as a barrier to interferon-free HCV treatment for patients receiving OAT.
Primary Funding Source: Merck & Co.
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| http://dx.doi.org/10.7326/M16-0816 | DOI Listing |
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