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DAA Cure Rate 75% in HCV/HIV Cohort With Ongoing Barriers to Care
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IDWeek 2015, October 7-11, San Diego
Mark Mascolini
Three quarters of HCV/HIV-coinfected people with ongoing barriers to care--such as drug use and depression--eradicated HCV with direct-acting antiviral (DAA) regimens in a small University of California, San Diego (UCSD) analysis [1]. Cure rates were statistically similar in patients with and without identified barriers to care.
Although HCV guidelines endorse DAA therapy for people with ongoing drug problems, the UCSD team noted, health care payers continue to restrict access to DAAs in HCV/HIV-coinfected people with barriers to care because outcome data in this population remain limited. To fill this gap, the UCSD team analyzed HCV response in all coinfected people treated with interferon-free DAA regimens throughout 2014. Depending on genotype, availability, and tolerability, patients took (1) sofosbuvir/simeprevir with or without weight-based ribavirin, (2) sofosbuvir/ribavirin, or (3) coformulated sofosbuvir/ledipasvir. People began HCV therapy if they had an undetectable HIV load and consistently kept appointments regardless of ongoing barriers to care.
The investigators used random-effects modeling to compare proportions of HCV/HIV patients cured in the dual-therapy era (pegylated interferon/ribavirin, 2008-2011), the triple-therapy era (pegylated interferon, ribavirin, and telaprevir, 2011-2013), and the DAA era (2014). Barriers to care included self-reported illicit substance use and/or alcohol use, screening for depression with the PHQ-9 inventory followed by formal psychiatric evaluation, and professional assessment of unstable housing.
The analysis focused on 30 coinfected people taking DAA regimens in 2014, 23 (77%) infected with HCV genotype 1a, 5 (17%) with genotype 2 or 3, and 2 (7%) with genotype 4. Twenty-two people (73%) had cirrhosis, and 10 of them had prior liver decompensation. Almost half of the study group had an HCV treatment failure on their record, including 3 in whom triple therapy failed and 1 in whom sofosbuvir/daclatasvir failed in a clinical trial. Of the 30 study participants, 25 (83%) achieved sustained virologic response (SVR) and remain alive. Three people had relapses after stopping HCV therapy and 2 died.
Sixteen of the 30 participants (53%) had significant ongoing barriers to care, including 12 with drug use or "marginal alcohol sobriety." Nine people had active neuropsychiatric disease. Similar proportions of people with ongoing barriers to care got treated for HCV in this clinic during the dual-therapy era (25 of 39, 64%) and the triple-therapy era (14 of 25, 56%).
Viral eradication rates rose from 39% with dual therapy to 48% with triple therapy to 83% with DAAs. After statistical adjustment for factors associated with HCV therapy outcomes, eradication rates were similar in people with and without ongoing barriers to care. In the DAA era, the eradication rate was 75% in people with barriers to care (95% confidence interval 48% to 93%), which was not statistically different from the 93% rate in people without barriers to care (95% confidence interval 66% to 100%). Cure rates with and without barriers to care were 50% and 45% with triple therapy and 40% and 36% with dual therapy. [from Jules: in a larger study with more patients the 93% SVR in those without barriers to care (non-drug users; see graph below) may be statistically significantly greater than the 75% SVR for those with barriers/who used drugs, I think it would be, BUT that is not an excuse not to offer treatment to ALL; in HIV after protease inhibitors first came out in 1996 for several years there were questions regarding whether IDUs should be treated for the same reasons, adherence, lower response rates, but eventually everyone realized we should treat these groups of patients. Its the same here for HCV, just because the SVR rate is lower is not an excuse not to treat them. Today in HIV we treat ALL, response rates are lower in African-Americans & certain other patient populations BUT we treat them, can you imagine the public outcry if we denied treatment for these patients. Its the same in HCV, ALL should be treated, we should however be providing just as we do in HIV support services for the clinic & the patient to optimize SVR rates, thats what we do in HIV, thats how over the years we got response rates to increase and of course due to improved ART treatments, but in HCV we already have great treatment regimens & only 12 week treatment courses so support services programs should be more effective in HCV.]
The researchers suggested their findings may "provide quantitative estimates for third-party payers and health policy makers." They argued that "protocols of third-party payers that require negative urine toxicology tests as an absolute criterion for HCV treatment eligibility should be revised."
Reference
1. Cachay E, Wyles D, Lucas Hill L, et al. The impact of direct acting antivirals in the cure of HCV in HIV-infected patients with ongoing barriers to care. IDWeek 2015, October 7-11, San Diego. Abstract 1672. https://idsa.confex.com/idsa/2015/webprogram/Paper51439.html
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Reported by Jules Levin
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