September 15, 2016
Among patients coinfected with hepatitis C (HCV) and HIV, sustained virologic response 12 weeks after HCV therapy ended (SVR12) was significantly higher with simeprevir (SMV) and sofosbuvir (SOF, Sovaldi) plus ribavirin (RBV) than with SOF/RBV in a two-center study. SVR12 did not differ significantly between SMV/SOF/RBV and SMV/SOF in this 89-person analysis.
HCV/HIV-coinfected patients attain high SVRs with HCV direct-acting antivirals (DAAs) in clinical trials, but less is known about how well contemporary DAA regimens promote SVR in real-world clinical practice. SMV and SOF are two well-studied and often-prescribed DAAs. But SMV/SOF has not been formally evaluated in coinfected patients. Clinical researchers at two New York City medical centers conducted this observational analysis to determine how well SMV- and SOF-containing regimens -- with or without RBV -- control HCV in HCV/HIV-coinfected adults.
This observational cohort included all HCV/HIV-coinfected adults with HCV genotype 1 who began a SOF-containing regimen between December 2013 and December 2014 at New York's Mount Sinai Hospital or Brooklyn Hospital Center. Courses lasted 12 weeks for patients taking SMV/SOF or SMV/SOF/RBV and 24 weeks for those taking SOF/RBV. The analysis excluded patients taking a DAA other than SMV or SOF and patients who had previously taken SMV, SOF, daclatasvir (Daklinza) or ledipasvir. The researchers determined SVR12 (1) by intention-to-treat analysis including all patients who began therapy and (2) by per-protocol analysis including patients who completed treatment and follow-up.
By intention-to-treat analysis, 63 of 89 people (71%) achieved SVR12, including 31 of 41 (76%) on SMV/SOF, 16 of 17 (94%) on SMV/SOF/RBV and 16 of 31 (52%) on SOF/RBV. SVR12 was significantly higher with SMV/SOF +/- RBV than with SOF/RBV (81% versus 52%, P < .01) but not significantly higher with SMV/SOF/RBV than with SMV/SOF (94% versus 76%, P = .15). In the per-protocol analysis, 63 of 79 patients attained SVR12, including 31 of 35 (89%) on SMV/SOF, 16 of 16 on SMV/SOF/RBV and 16 of 28 (57%) on SOF/RBV.
Multivariable analysis determined that SMV/SOF/RBV was associated with 18 times higher odds of SVR12 than SOF/RBV (odds ratio [OR] 18.22), but the confidence interval was wide (95% confidence interval [CI] 2 to 165.87). SMV/SOF was not independently associated with higher odds of SVR12 than SOF/RBV (OR 2.26, 95% CI 0.77 to 6.66). Compared with SMV/SOF, SMV/SOF/RBV trended toward significantly greater odds of achieving SVR12 (OR 8.15, 95% CI 0.84 to 79.39, P = .071) in multivariable analysis.
Among 11 patients in whom SMV/SOF +/- RBV failed, one with class C cirrhosis before treatment died after treatment with SMV/SOF. Among patients who did not achieve SVR12 while taking a SMV-containing regimen, three stopped treatment before completing 12 weeks, two of them with serious adverse events: severe abdominal pain and vomiting in one, and lip swelling plus new-onset lower-extremity edema with full-body hyperpigmentation in the other. Clinicians could not establish whether SMV or SOF explained these adverse events.
The authors conclude that "SMV/SOF is an effective option with minimal adverse effects for most HIV-positive patients with HCV [genotype 1]." They caution that "[p]ending further data, SMV should be used with caution in patients with decompensated cirrhosis[.]" They add, "Although SMV may have significant [drug-drug interactions] with [antiretrovirals], SMV/SOF +/- RBV may continue to be a valuable option" for patients in whom an NS5A inhibitor-based regimen has failed.
Mark Mascolini writes about HIV infection.
Copyright © 2016 Remedy Health Media, LLC. All rights reserved.
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