CHICAGO — When it comes to the latest HCV regimens, so-called “special” patient populations may have to accept the fact that they are actually quite ordinary.
“Special populations are no longer special,” said Nancy S. Reau, MD, assistant professor of medicine at the University of Chicago, and HCV Next Editorial Board member, during a presentation here. “Sorry, you don’t get to have special privileges anymore — you’re just as generic as the rest of us.”
If ‘generic’ means achieving treatment outcomes that are as excellent as those attained by their non-special peers, these formerly difficult-to-treat populations will likely be thrilled to relinquish their ‘special’ status.
Nancy S. Reau
In her presentation at Digestive Disease Week 2014, Reau outlined these once-problematic patient populations and cited some exciting recent findings from clinical trials in these populations.
A population that once posed a significant challenge to HCV treatment, according to Reau, was patients with cirrhosis. She cited study findings from the ION-1 phase 3 trial, a randomized, open-label clinical trial of combination ledipasvir (Gilead) and sofosbuvir (Sovaldi, Gilead) with or without ribavirin. In ION-1, researchers evaluated these treatment regimens in 865 treatment-naive genotype 1 patients with HCV, including cirrhotic patients.
“The efficacy from the cirrhotic arms for these regimens is exactly the same,” Reau said. “So really, it seems that cirrhosis is not that special.”
Reau also reviewed data from the TURQUOISE 2 trial, which evaluated ABT-450, ritonavir and ABT-267, as well as ABT-333 with ribavirin.
In the trial, even among difficult-to-treat patients with cirrhosis, the three-drug combination was effective.
Decompensated cirrhosis patients
Reau also discussed interim results of a study evaluating a 48-week regimen of sofosbuvir and ribavirin in patients with decompensated cirrhosis and portal hypertension. Patients with portal hypertension and Child-Pugh class B had a 93% viral suppression at 24 weeks; the rate among those with class A was 100%.
She added that viral suppression appears to be the tip of the iceberg.
“Maybe even more exciting is that we’re seeing a suggestion that suppressing the virus leads to clinical benefit,” she said. “When they compared the patients who were monitored to the ones who were actually treated, their platelet counts improved, the albumin levels improved, their [alanine transaminase] improved, ascites resolved, and encephalopathy resolved. It’s not exactly applicable to the real world yet, but it’s very exciting.”
Pre-transplant, HIV populations
Reau cited a phase 2 study of HCV patients with well-compensated cirrhosis and liver cancer who underwent a regimen of sofosbuvir and ribavirin prior to liver transplant.
“This study showed that in this group, if you can suppress the virus for 30 days before transplant, you’ve essentially eliminated hepatitis C post-transplant,” she said.
Further, the superior results seen with the latest regimens have given rise to debate about whether pre-transplant treatment is even needed.
“There’s been some argument about whether you should treat before or after transplant because the regimens are becoming so efficacious, so tolerable, and with so few drug-drug interactions, you may not need to treat a patient before transplant, you’d rather just treat them after,” she said. “I’m not going to show you post-transplant studies, but I will say there are also very efficacious.”
Finally, Reau addressed the special population of HIV-infected patients. She cited an NIH study showing that a combination of sofosbuvir and ledipasvir yielded results comparable to those seen in monoinfected patients.
“The SVR rates, although small, are 100% for this regimen in a coinfected individual.”
She also discussed positive findings seen in the NIH SYNERGY study, which is evaluating the new drugs GS-7977, GS-5885 and GS-9669.
“This study showed that a three-drug regimen for 6 weeks in a treatment-naive, non-cirrhotic genotype 1 population, [produced] SVR rates [of] 95% to 100%.”
She added that despite these increasingly promising findings, further research is always needed.
“Ideal therapy is still a moving target.”