Viral Response to DAAs Linked to Diabetes Control
BOSTON, MA—Among patients with diabetes, HbA1c significantly improved with hepatitis C virus (HCV) clearance, a retrospective cohort study presented at The Liver Meeting® 2016 concluded.
In fact, an “HbA1c reduction of 0.63 percentage points was achieved, which is similar to improvements seen in antidiabetic medication trials,” noted Sheena LeClerc, PharmD, of the department of gastroenterology at the Louis Stokes Veterans Affairs Medical Center in Cleveland, OH, and coauthors.
Of the 2.7 to 3.9 million cases of chronic HCV in the United States, 15% to 50% of patients also have a diagnosis of type 2 diabetes (T2DM). Some studies have demonstrated an association between HCV and progression of insulin resistance to T2DM as well as improved virologic response from treatment for HCV.
However, the “predictability and magnitude of improved glycemic control in diabetic patients who achieve sustained virologic response (SVR) from HCV treatment is unknown,” Dr. LeClerc pointed out, adding that having a “better understanding of the impact of achieving SVR on antihyperglycemic medication requirements in diabetic patients will allow for safer management.”
For example, patients may have a decreased need for medication and an increased risk for hypoglycemia events, justifying closer follow-up of diabetes management.
The study included veterans with a diagnosis of diabetes initiated on HCV direct-acting antiviral (DAA) agents between February 1, 2014, to October 1, 2015, at the Cleveland VA Medical Center. Patients were identified using ICD-9 and 10 codes and medication dispensing history. Patients were excluded if they were not on antidiabetic medications at the start of HCV treatment or did not complete a full hepatitis C treatment course.
The co-primary endpoints were change of antihyperglycemic medications categorized as de-escalation, no change, or escalation from baseline to end of HCV treatment, and change from baseline to 3 months after treatment among patients who achieved SVR12.
The study included 131 patients, 98% of whom were male with a mean age of 63 years (range 51 to 72). The majority were African American (59%); 37% were Caucasian, non-Hispanic and 4% were other or unknown. About half (53%) had advanced fibrotic liver disease and 90% were genotype 1.
The HCV regimens included sofosbuvir/ribavirin (5%), sofosbuvir/ribavirin/peginterferon (8%), sofosbuvir/simeprevir (5%), ledipasvir/sofosbuvir ± ribavirin (74%), and ombitasvir/paritaprevir/ritonavir and dasabuvir ± ribavirin (8%).
Baseline number of diabetes medications was one in 81 patients (92%), 2 in 36 (27%), 3 in 12 (9%), and 4 in 2 (2%).
Among the 59 patients who had achieved SVR12, mean comparison of A1c at baseline and at 4 months' post-treatment showed a decline from 7.4% to 6.8%, a difference of 0.63% (95% CI: 0.3, 0.93; P<0.001).
Of the 133 patients who had de-escalation of diabetes medications, 122 achieved SVR12 and 9 did not. Among those who achieved SVR12, 27% (n=33) de-escalated medications from baseline to 3 months' post-treatment and 19% (n=23) from baseline to end of treatment. Only 1 of the 9 patients who did not achieve SVR 12 de-escalated diabetes medication from baseline to end of treatment.
The implications of these findings are that “early medication adjustments may be necessary,” Dr. LeClerc noted.
Further studies are required to evaluate long-term effects on diabetes control and to determine sustained effect.