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SVR12 Similar in HCV-1 Patients With or Without HIV in Four LDV/SOF Trials
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IDSA/IDWeek 2015, October 7-11, San Diego
Mark Mascolini
Nearly identical, high proportions of HCV genotype 1 patients with or without HIV infection attained 12-week sustained virologic response (SVR12) to ledipasvir/sofosbuvir (LDV/SOF, HARVONI), according to analysis of 4 phase 3 ION trials, even though the coinfected group included higher proportions starting LDV/SOF with cirrhosis or treatment experience [1]. Black race predicted relapse in HCV/HIV-coinfected people.
US/Canadian researchers who conducted this analysis noted that AASLD/IDSA guidelines advocate treating HCV/HIV-coinfected people just as one treats HCV-monoinfected people, after managing potential interactions with antiretrovirals. These investigators analyzed results of the phase 3 ION 1, 2, 3, and 4 trials to compare SVR12 and other outcomes in people infected only with HCV-1 (ION 1, 2, and 3) and those coinfected with HCV-1/HIV (ION 4). They defined SVR12 as HCV RNA below 25 IU/mL 12 weeks after treatment ended.
The four trials enrolled patients in the United States, Canada, and New Zealand. This analysis focused on 539 HCV-monoinfected people in ION 1-3 and 327 coinfected people in ION 4, all taking single-tablet LDV/SOF. The analysis did not consider people who took ribavirin with LDV/SOF in ION 1-3. Age averaged 54 in the combined ION 1-3 trials and 52 in ION 4. Respective proportions of men were 61% and 83%, of blacks 17% and 35%, and of Hispanics 9% and 17%. A lower proportion in ION 1-3 than in ION 4 had cirrhosis (10% versus 20%) or treatment experience (20% versus 55%), and average HCV load was lower in the combined ION 1-3 group (6.4 versus 6.7 log10 IU/mL).
The SVR12 analysis included 536 HCV-monoinfected people, 518 of whom achieved SVR12, and 327 HCV/HIV-coinfected people, 314 of whom achieved SVR12 (97% and 96%). SVR12 rates hardly varied by HCV treatment experience in either the combined ION 1-3 group (97% naive versus 94% experienced) or the ION-4 group (95% versus 97%). Pretreatment cirrhosis also had little impact on SVR12 in either ION 1-3 or ION 4. Among treatment-naive people, those who also had cirrhosis had a somewhat higher SVR12 rate in ION 1-3 than in ION 4 (94% versus 85%). But among treatment-experienced people who also had cirrhosis, the response rate was lower in ION 1-3 than in ION 4 (86% versus 98%). Genotype 1 subtype did not affect SVR12 rates in either ION 1-3 or ION 4.
Black versus nonblack race did not affect SVR12 response in ION 1-3. But in ION 4 response rates were 90% in blacks and 100% in nonblacks. Multivariate analysis identified black race as the only independent predictor of relapse in ION-4 patients. Pharmacokinetic analysis of ION 4 participants did not disclose clinically relevant differences in concentrations of LDV or SOF by race, antiretroviral regimen, or treatment outcome.
Grade 3 or 4 adverse events arose in 2% taking LDV/SOF in ION 1-3 and in 4% in ION 4. Fewer than 1% stopped study drugs because of adverse events in ION 1-3, and no one stopped treatment for that reason in ION 4. Serious adverse events developed in 1% in ION 1-3 and in 2% in ION 4.
The ION investigators concluded that 12-week efficacy of LDV/SOF is similar in HCV-monoinfected people and HCV/HIV-coinfected individuals. They proposed that "LDV/SOF represents a highly effective treatment option for patients with HIV/HCV coinfection and HCV monoinfection."
Reference
1. Naggie S, Cooper C, Sulkowski M, et al. Ledipasvir/sofosbuvir is safe and effective for the treatment of patients with genotype 1 chronic HCV infection in both HCV mono-and HCV/HIV co-infected patients. IDWeek 2015, October 7-11, San Diego. Abstract 1671. https://idsa.confex.com/idsa/2015/webprogram/Paper53221.html
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