May 15, 2015
This year's conference had many outstanding presentations about hepatitis C drugs in development -- too many to cover in one edition of the HCV Advocate newsletter. As a result, we will be covering EASL in this edition as well in the next Mid-Monthly edition. I have tried to pick out a couple of most interesting studies from the presentations from AbbVie, BMS, Gilead, and Merck. Many of these combinations work at different stages of the replication stages of the hepatitis C virus thus preventing the virus from becoming resistant to medications. There were also some important studies on estimating the number of lives that could be saved by being cured, adherence to medications, treating people pre- and post-transplant, and the possibility of shortening treatment to 4 or 6 weeks.
The study examined how many deaths would be prevented treating early vs. deferring using AbbVie's HCV genotype 1 3D treatment. In the study the disease model used 8 disease progression states: Metavir fibrosis stages 0-4; decompensated cirrhosis; liver cancer and liver transplantation; three stages of cure; recovery from acute infection; liver-related death and death from non-liver related causes. Reinfection was also factored into the analysis using the disease progression model on untreated patients.
The Bottom Line: The results all applied to patients with genotype 1. Deaths from hepatitis C were higher when treatment was deferred until liver disease was more severe. AbbVie's 3D with and without ribavirin significantly reduced complications and deaths from hepatitis C. This included all patients with minimal to severe disease. As it states in the title of the presentation, SVR or cure reduces death 5 to 10 fold.
Editorial Comment: This is a no brainer -- treating early reduces pain, suffering and death. Waiting until severe disease occurs causes people to experience needless suffering and possible severe outcomes. People with severe disease who are cured of hepatitis C will continue to need medical monitoring that will require even more medical expense.
Adherence to therapy is important for achieving a cure and preventing drug resistance to HCV inhibitor therapy. AbbVie's 3D drug combination therapy requires taking a drug once daily, another drug twice daily and when ribavirin is required it is taken twice daily. The current study examined the adherence to AbbVie's 3D combination ± ribavirin in their SAPPHIRE trials. The investigators were able to establish adherence by pill count and from a device attached to the cap of the pill bottles (MEMSCaps) that recorded when the bottles were opened and closed. The overall cure rates for the SAPPHIRE trials was 96.4%
The Bottom Line: Overall, 99% of the patients were adherent based on the pill count data. Using the MEMSCaps electronic recording process, the ribavirin adherence rate was greater than 98%.
Editorial Comment: Very high adherence rates were recorded using both methods. Hopefully the high adherence rate in the trial also translates into high adherence rates in real world settings. If you have seen the Viekira Pak package it certainly helps to keep people on track to take their daily pills. It would be useful to have "real world" information to find out if adherence is similar to the information in this clinical trial.
This study examined the use of daclatasvir, sofosbuvir plus ribavirin in people with hepatitis C and advanced cirrhosis or people who had a liver transplant and had hepatitis C after the liver transplant. There were two groups: The first group comprised 60 patients who had advanced cirrhosis. The second group comprised 53 patients who had advanced cirrhosis (liver cancer patients allowed), but who had received a liver transplant. The second group received 12 weeks of treatment ≥3 months after their transplant.
All genotypes, treatment -naive and treatment- experienced were allowed in the study. There was a total of 60 advanced cirrhotic patients and 53 post-transplant patients in the study. Most of the patients in both groups were male, White, genotype 1a (65 pts) and genotype 3 (17 pts). The fibrosis scale in the post-transplant group- F0-F3 (68%), F4 (30%). I am just listing the genotype 1 and 3 results below.
The Bottom Line: In the patients with advanced cirrhosis the cure rates were genotype 1a 76% and genotype 1b 100%; in those that were post-transplant the cure rate was genotype 1a 97% and genotype 1b 90%. Genotype 3 advanced cirrhotic patients had an 83% cure rate and the post-transplant patients had a 91% cure rate. The most common side effects were headache, fatigue, anemia, diarrhea, nausea and joint pain.
Editorial Comment: The results are similar to the results seen in the Gilead study below. Together, they reflect a growing body of evidence that it is safe and effective to treat pre- and post-transplant patients.
Treatment cure for genotype 3 is limited especially for those with cirrhosis. The current analysis is the interim results from a study that is being conducted with 4,000 patients. This analysis includes 601 genotype 3 patients with advanced disease (staged as F3 or worse). The patients were mostly male (75%), mostly mono-infected with HCV (83%), had cirrhosis (77%), and were previously treated (73%). Forty-one patients were treated for 12 weeks; 560 were treated for 24 weeks; 481 patients received daclatasvir/sofosbuvir and 117 received daclatasvir/sofosbuvir plus ribavirin.
The Bottom Line: SVR 4 (4 weeks post-treatment) rates were as follows:
12 week treatment group:
24 week treatment group:
There were 4 treatment discontinuations -- one related to adverse events, 2 deaths and 1 due to patient decision. It was noted that extending the treatment period to 24 weeks increased the cure rates in cirrhotic patients with HCV genotype 3.
Editorial Comment: Extending treatment duration helps to increase the cure rates substantially. Personally, I want to wait for the final results and to find out how much the cost of 24 weeks will be to see if price is going to be a concern for patients.
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