(Republished from the UNC Health Care and UNC School of Medicine Newsroom)
A new UNC School of Medicine study, led by Donna Evon, PhD, a clinical health psychologist and research professor in the division of gastroenterology and hepatology in the department of medicine, finds that self-reported medication adherence was very high in a group of patients with chronic hepatitis C who were treated with direct acting antiviral (DAA) medications – despite a high rate of mental health disturbance and substance use in these patients.
“A very critical finding of this study is that mental health disturbance and substance use were not associated with nonadherence to taking DAA medications,” Evon said. “These findings provide no justification for providers or insurance payers to use these patient characteristics as a basis for denying access to hepatitis C treatment, as has been done in the past and, to some extent, continues today.”
The study, published online in the Journal of General Internal Medicine, is based on an analysis of data collected as part of The Patient-Reported Outcomes Project of HCV-TARGET (“PROP UP”), a multi-center observational study funded by the Patient-Centered Outcomes Research Institute (PCORI) to evaluate and characterize patient reported outcomes during and after DAA therapy. Evon is the principal investigator of the PROP UP study who led 11 U.S. liver centers participating in the 3-year project.
PROP UP enrolled 1,601 study participants who were included in the analyses. Sixty-two percent were prescribed sofosbuvir/ledipasvir (trade name: Harvoni®), 21% were prescribed sofosbuvir/velpatasvir (trade name: EPCLUSA®), 11% were prescribed grazoprevir/elbasvir (trade name: Zepatier®) and 5 percent were prescribed ombitasvir/paritaprevir/ritonavir+ dasabuvir (trade name: Viekira Pak®).
During DAA treatment, patients self-reported missed doses of medication during the early and late phases of treatment. Medication nonadherence was self-reported by 11 percent of patients. Medication nonadherence worsened over time from early to late treatment, and was twice as high among patients who consumed alcohol at baseline, compared to patients who did not consume alcohol at baseline. This finding suggests that people who consume alcohol before treatment need additional support services to remain adherent to treatment. The researchers were not able to determine statistically in a multivariable model if nonadherence was a risk factor for not achieving a viral cure, but the correlational data suggested a negligible relationship, Evon said.
Evon is also the co-first author of another article, published in the September 2019 issue of the Journal of Hepatology, based on data from the PROP UP study. Souvik Sarkar, MD, PhD, of the University of California at Davis, is the other co-first author.
During DAA therapy for Hep C, symptoms and functioning improved slightly but not in a clinically meaningful manner. However, patient experiences were highly variable: while baseline symptoms stayed the same for some, other patients experienced worsening or improvements in baseline symptoms during therapy. Patients who were aged 35 to 55 or those with mental health disturbance or more health comorbidities before treatment, tended to experience the greatest symptom improvements during DAA therapy.
Three months after DAA treatment ended, 95 percent of patients were cured of Hep C. Most patients (91%) completed their patient-reported outcomes survey before learning from the doctor if they had been cured or not. Overall, patients who were cured (n=1,346) reported varying improvements in all symptoms (neuropsychiatric, pain, gastrointestinal); however, they experienced clinically significant improvements in fatigue, sleep disturbance, and overall quality of life. Patients with and without cirrhosis experienced similar improvements in symptoms and functioning.
“These findings are noteworthy for patients given high rates of sleep and pain disorders among people infected with chronic hepatitis C. In addition to being cured of a stigmatizing, infectious, and potentially life-threatening disease, patients can look forward to better functioning, quality of life, energy and sleep after being cured,” Evon said.
In a small group of patients who were not cured (n=64), they experienced little to no improvements. Given that patients did not have knowledge of cure status when completing their surveys after treatment, these findings provide evidence that improvements in symptoms and functioning after cure may be the result of underlying physiological processes and not merely due to a “psychological placebo effect.”
Co-investigators of the PROP UP study from UNC include Paul W. Stewart, PhD; Jipcy Amador, MS; Carol E. Golin, MD; and Michael W. Fried, MD.