Real‐world impact of direct acting antiviral therapy on health‐related quality of life in HIV/Hepatitis C co‐infected individuals

Abstract

Clinical trial results of direct acting antivirals (DAAs) for the treatment of hepatitis C virus (HCV) have shown improvements in health-related quality of life (HR-QoL). However, the extent to which these results are broadly generalizable to real-world settings is unknown. We investigated the real-world impact of oral DAA therapy on HR-QoL among individuals coinfected with HIV/HCV. We used data from the Canadian HIV/HCV Co-Infection Cohort Study that prospectively follows 1795 participants from 18 centres. Since 2007, clinical, lifestyle, and HR-QoL data have been collected biannually through self-administered questionnaires and chart review. HR-QoL was measured using the EQ-5D instrument. Participants initiating oral DAAs, having at least one visit before treatment initiation and at least one visit after DAA treatment response was ascertained, were included. Successful treatment response was defined as a sustained viral response (SVR). Segmented multivariate linear mixed models were used to evaluate the impact of SVR on HR-QoL, controlling for pretreatment trends. 227 participants met our eligibility criteria, 93% of whom achieved SVR. Before treatment, the EQ-5D utility index decreased 0.6 percentage-point/y (95% CI, -0.9, -0.3) and health state was constant over time. The immediate effect of SVR resulted in an increase of 2.3-units (-0.1, 4.7) in patients' health state and 2.0 percentage-point increase (-0.2, 4.0) in utility index. Health state continued to increase post-SVR by 1.4 units/y (-0.9, 3.7), while utility trends post-SVR plateaued over the observation period. Overall using real-world data, we found modest improvements in HR-QoL following SVR, compared to previously published clinical trials.

Evaluation of Safety and Effectiveness of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Switch Followed by Ledipasvir/Sofosbuvir HCV Therapy in HIV–HCV Coinfection

“…We evaluated the impact of switching to once-daily single-tablet E/C/F/TAF followed by treatment of HCV with LDV/SOF on health-related quality of life (HR-QoL), alcohol and drug use, and physical activity. Consistent with a recent Canadian HIV–HCV cohort study, DAA treatment in the HIV–HCV-coinfected population did not have any significant effect on self-perceived health states during treatment or on post-treatment response [30]. Although there was no immediate impact on HR-QoL, there was a decrease in activity level during treatment in a population that was relatively active at baseline.…”

Clinical and Patient-Reported Outcomes of Direct-Acting Antivirals for the Treatment of Chronic Hepatitis C Among Patients on Opioid Agonist Treatment: A Real-world Prospective Cohort Study

“…Still, compared with the findings of a post hoc analysis of phase 3 clinical trial data on PROs among OAT patients in antiviral treatment [ 19 ], the improvements in our study were modest, especially with regard to the PCS of the SF-12. However, as smaller improvements were also found in other real-world populations [ 33 , 34 ], 1 explanation might be that the exclusion of “difficult-to-treat” patients from registration trials results in better PROs. In our sample, health-related quality of life (PCS and MCS) at baseline was substantially reduced compared with the general population, which is consistent with a recent German large-scale study among OAT patients [ 35 ].…”

Life after hepatitis C cure in HIV‐infected people who inject drugs and men who have sex with men treated with direct‐acting antivirals in France: Health perceptions and experiences from qualitative and quantitative findings (ANRS CO13 HEPAVIH)

“…QoL improvements observed in such 'real-life' conditions have been shown to be more modest than those observed among patients enrolled in HCV clinical trials. 22 Our qualitative findings provide additional nuance into how some of these outcomes 'play out' in the everyday lives of those previously [26][27][28] Indeed, although the increasing availability and accessibility of DAA have resulted in an era in which HCV microelimination among key populations has become a pragmatic and attainable possibility, 29,30 there remains an important need to consider how the scale-up of DAA might have broader non-clinical and/or experiential (eg relationship-based) impacts. 23 In addition, to reduce the risk of HCV reinfection in these key populations over the long-term, post-SVR follow-up care should include sustained attention to these evolving contexts, including expanded access to pre-exposure prophylaxis (PrEP) for HIV-negative individuals.…”