Daclatasvir/Asunaprevir Safe, Effective in Elderly With HCV GT1
SAN FRANSCICO, CA—Despite some discontinuations, daclatasvir plus asunaprevir is an effective and safe combination for elderly patients with hepatitis C virus (HCV) infection genotype (GT) 1, a population that was "left behind" when interferon-based therapy was introduced, according to authors of a study presented at The Liver Meeting® 2015.
In fact, in Japan, combination therapy with daclatasvir and asunaprevir is currently “the only option” for patients with HCV GT1 infections, noted Shuhei Hige MD, PhD, of the Department of Hepatology, Sapporo-Kosei General Hospital, in Sapporo, Japan.
In this study, 293 patients were treated with fixed daily doses of daclatasvir (60mg) and asunaprevir (200mg) for 24 weeks. One hundred and nineteen (41%) of patients were cirrhotic, Dr. Hige noted.
Median patient age was 70.0 years. Patients were categorized by age: Group I was <70 years (n=135); Group II, 70–74 years (n=75) and Group III was ≥75 years (n=83).
One week following treatment initiation, Dr. Hige and colleagues measured trough value of asunaprevir for 143 patients admitted to the hospital. FibroscanTM was used to measure liver stiffness and the PCR-Invader method assessed resistance-associated variants (RAVs) at L31 and Y93 in NS5A. Sustained viral response was evaluated 4 weeks after therapy ended (SVR4).
Increasing age was associated with baseline levels of hemoglobin, prothrombin (PT) activity, albumin, γGTP, creatinine, estimated GFR, total cholesterol, LDL-cholesterol, HbA1c, blood urea nitrogen, DCP (PIVKA-II), HCV RNA, hyaluronic acid, and FIB-4 index score (P<0.05), Dr. Hige reported. There was no association found between age and adverse events.
"Trough level of ASV at Week 1 showed significant correlation with type IV collagen, FIB-4 index and liver stiffness measurement," Dr. Hige reported. "On the other hand, it did not show correlation with age."
"SVR4 was achieved in 126 of 142 patients (88.7%)," Dr. Hige reported. "SVR4 rate was 90.3%, 92.9%, 78.6% for Groups I/II/III."
Of 16 patients who did not attain SVR, 7 showed viral breakthrough and 5 discontinued due to a "symptomatic reason" or, in one case, a hematologic disorder, Dr. Hige reported. Six of 7 viral breakthrough cases had resistance-associated variants (RAVs) and 5 cases were older than 70 years.
“Despite the adverse conditions related to physiological functions, complications, and biochemical abnormalities, the efficacy of daclatasvir plus asunaprevir combination therapy for elder patients [worked] fairly well," Dr. Hige and colleagues concluded.