Fewer Medical Events Seen with Daclatasvir/Sofosbuvir in HCV GT3 Model

SAN FRANSCISCO, CAWhen all patients with hepatitis C virus (HCV) with genotype 3 (GT3) infection are treated with daclatasvir/sofosbuvir, “substantially fewer medical events and lower medical costs are accrued” when “compared with scenarios in which no one is treated or treatment is limited to F3/F4 patients,” results of a study using a Markov model presented at The Liver Meeting® 2015 concluded.

Patients with HCV GT3 “fail antiviral therapy more often than patients infected with other GTs,” noted Boris Gorsh, PharmD, Bristol-Myers Squibb, Plainsboro, NJ, and colleagues.

The daclatasvir/sofosbuvir combination represents “a significant advancement” in the treatment of HCV in that only 12 weeks—vs. 24 weeks, as for other combination therapies—are required for patients to complete treatment.

The study’s objective was to estimate the number of medical events and direct medical costs that could be avoided if otherwise untreated patients with HCV GT3 were treated with daclatasvir/sofosbuvir.

Using a Markov model, the team estimated the number of medical events and costs experienced by a hypothetical cohort of 1,000 patients with HCV GT3—mean age, 54 years, 65% male—who had received daclatasvir/sofosbuvir vs. no treatment. Based on ALLY-3 study results, they assumed that 89% of patients treated with daclatasvir/sofosbuvir would achieve a sustained virologic response (SVR).

“Medical events and costs were assessed for three scenarios: overall HCV population (F0-F4) receives no treatment, only the F3/F4 subpopulation receives daclatasvir/sofosbuvir, and all patients (F0-F4) receive daclatasvir/sofosbuvir,” Dr. Gorsh explained.

Total medical events were defined “as the sum of compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, liver transplant, or liver-related death. Medical costs included monitoring and for treating complications and adverse events.

They modeled disease progression and costs over time horizons of 20 and 50 years.

Results showed that at 20 years, the fewest medical events and lowest direct medical costs were observed when all patients were treated with daclatasvir/sofosbuvir: 76 events and $14,343,786.

“When only F3/F4 patients received daclatasvir/sofosbuvir, medical events and costs were substantially higher,” 335 events and $68,414,213, they found. Events and costs were highest in the scenario where no one was treated, 729 events and $129,838,658.

“Similar results were seen over 50 years,” Dr. Gorsh noted: no treatment resulted in 1,258 events and $186,707,812; if only F3/F4 patients treated, it was 718 events and $106,185,781; and if all patients were treated, 131 events and $20,258,178.

Future analyses evaluating the impact of treatment duration and additional regimens are needed to better understand the full impact of new treatments in this population, noted Dr. Gorsh.