A new review of individuals co-infected with chronic hepatitis C virus (HCV) and human immunodeficiency virus 1 (HIV) suggests that the Food and Drug Administration (FDA)’s label of “special population with an unmet medical need” for such patients, should be re-evaluated.
The review – published in the journal Hepatology – identified studies dated between 2004 and 2017 using the PubMed, EMBASE, and Cochrane Library databases that investigated treatment of chronic HCV infection in those infected with HIV.
Past studies have shown that sustained virologic response (SVR) rates of interferon-based therapies for co-infected individuals have been particularly inadequate. However, the authors write, “the advent of direct acting antiviral (DAA) therapies has resulted in significant improvements in treatment rates for those with co-infection.”
They pointed to several large, recent trials that demonstrated SVR rates of >93% with DAA treatments, including ledipasvir/sofosbuvir (Osinusi et al. 2015; Naggie et al. 2015; Kowdley et al. 2014), ombitasvir/paritaprevir/ritonavir plus dasabuvir, daclatasvir/sofosbuvir (Wyles et al. 2015), and grazoprevir/elbasvir in co-infected patients (Rockstroh et al. 2015). These SVR rates were similar to those in mono-infected individuals.
Patient reported outcomes (PROs) after beginning DAA regimens in co-infected individuals have also shown similar rates of improvement in several domains to that of DAA regimens in mono-infected patients (Younossi et al. 2016). Mono-infected patients showed improvements in general health and emotional well-being during and after treatment with sofosbuvir/velpatasvir. Co-infected patients on the same regimen showed improvements in 19 of 26 PRO domains at 12 weeks after achieving SVR.
Clinical trials evaluating various DAA regimens demonstrate SVR rates of 93.5 to 98% with real-world SVR data ranging 90.9 to 98%. Despite these findings, the authors stressed that healthcare professionals “must remain vigilant, especially with regard to identifying drug-drug interactions, negative predictors of SVR, and barriers to care” in addition to counseling and patient education to prevent re-infection following SVR. Future studies should be directed at “identifying programs and interventions that reduce the risk of re-infection among this population,” concluded lead author, Cameron Sikavi, from UCLA Medical Center, Torrance, CA.
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