The FDA has approved sofosbuvir/velpatasvir to treat chronic hepatitis C virus (HCV) infection in patients with and without cirrhosis. It is the first drug or drug combination that is approved to treat all six major genotypes and, as such, has been widely anticipated for patients with genotype 2-6 HCV infections. It is approved in combination with ribavirin for patients with decompensated cirrhosis. Sofosbuvir/velpatasvir was approved on the strength of three studies of more than 1,500 patients with and without cirrhosis or compensated cirrhosis, which showed 95-99% of patients had no detectable virus at 12 weeks post treatment (SVR12). In combination with ribavirin for patients with decompensated cirrhosis, the SVR12 was 94%. Sofosbuvir/velpatasvir is marketed as Epclusa. Twelve weeks of therapy will be priced at $74,760, less than other HCV treatments.
The FDA has approved obeticholic acid for the treatment of primary biliary cirrhosis in combination with ursodeoxycholic acid. Obeticholic acid increases bile flow from the liver and suppresses bile acid production. The drug was granted fast-track designation, a process that facilitates development and expedites review of drugs intended to treat serious conditions for which there is no adequate treatment. The drug also received Orphan drug designation, which includes financial incentives for drug development, and it was approved under the accelerated approval program, which features less stringent requirements for endpoints of efficacy. Approval was based on a controlled clinical trial of 216 participants in which the biomarker alkaline phosphatase was lower at one year, a surrogate marker of efficacy. Improvement in survival or progression to cirrhosis has not been shown. Obeticholic acid is marketed as Ocaliva. It is expected to cost nearly $70,000 per year.
The FDA has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). Both medications are SGLT2 inhibitors that lower blood sugar by increasing renal excretion of glucose. The FDA has received 101 reports of acute kidney injury, some requiring hospitalization and dialysis, with canagliflozin or dapagliflozin use. There were four deaths and 15 cases requiring dialysis. The FDA recommends considering risk factors for acute kidney injury prior to starting canagliflozin or dapagliflozin, including dehydration, chronic kidney disease, congestive heart failure, and concomitant medications such as diuretics, angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers, and nonsteroidal anti-inflammatory drugs. Assess renal function periodically. Patients should seek medical attention immediately if they experience signs and symptoms of acute kidney injury ().