Update, February 9, 2016: The FDA has approved the expanded use of Daklinza®to include patients with hepatitis C virus (HCV), genotype 1. Further, the drug label will now state that it can be used in patients co-infected with HCV and HIV-1, those with cirrhosis and patients whose HCV recurred after a liver transplant.
Update, October 22, 2015: The US Food and Drug Administration (FDA) issued a warning that AbbVie’s Viekira Pak® and Technivie™, oral hepatitis C treatments, can cause liver damage in patients with underlying advanced liver cirrhosis. The manufacturer will include this information on the drugs’ labels. Further, US healthcare providers will be sent a letter with this update.
Update, July 24, 2015: The US Food and Drug Administration (FDA) approved two oral drugs to treat hepatitis C virus (HCV). AbbVie’s Technivie™ is for patients with genotype 4 who do not have cirrhosis. It is the first all-oral, interferon-free direct-acting antiviral for this genotype, which is considered difficult to treat. Technivie contains the same 3 drugs as AbbVie’s VIEKIRA PAK™--ombitasvir, paritaprevir and ritonavir. In addition, patients take ribavirin twice daily. In a clinical trial, 100% of adults who took Technivie with ribavirin for 12 weeks achieved sustained virologic response (SVR) 12 weeks after completing the regimen. SVR is considered an indication that patients have cleared the virus.
Bristol-Myers Squibb’s Daklinza™ (daclatasvir) was approved for use with Gilead’s Sovaldi® (sofosbuvir) to treat patients with HCV genotype 3. Daklinza is an NS5A replication complex inhibitor; Sovaldi is a polymerase inhibitor. After genotype 1, genotype 3 HCV is the most common. It is considered difficult to treat. In clinical studies, 86% of patients who had been on previous regimens achieved SVR 12 weeks after their 12-week regimen of Daklinza plus Sovaldi had ended.
Update, December 19, 2014: The US Food and Drug Administration (FDA) approved AbbVie’s VIEKIRA PAK™ to treat people with hepatitis C virus (HCV) type 1. The all-oral regimen combines three drugs in one pill: ombitasvir, an NS5A inhibitor; paritaprevir, a protease inhibitor; and the protease inhibitor ritonavir. In addition, patients take dasabuvir, a nonnucleoside protease inhibitor. Some patients are also prescribed ribavirin. In six clinical trials of 2,308 patients with and without cirrhosis, 91%-100% achieved sustained virologic response (SVR) 12 weeks after completing the regimen. SVR is considered an indication that patients have cleared the virus.
Update, November 5, 2014: The US Food and Drug Administration (FDA) approved the combination of Janssen’s Olysio™(simeprevir) and Gilead’s Sovaldi® (sofosbuvir) to treat patients with chronic hepatitis C virus, genotype 1. Previously, they were approved only for use separately, in combination with pegylated interferon and/or ribavirin. The all-oral daily therapy should be taken for 12 weeks for patients without cirrhosis and 24 weeks for patients with cirrhosis.
Update, October 10, 2014: On October 10, 2014, the US Food and Drug Administration (FDA) approved Harvoni™, a combination of ledipasvir, an NS5A inhibitor, and sofosbuvir, a polymerase inhibitor, to treat patients with chronic hepatitis C virus (HCV) infection, genotype 1. The drug, manufactured by Gilead, is the first combination pill to treat HCV. It is also the first to do so without the use of interferon or ribavirin, previously considered the gold standard for treatment. Treatment-experienced patients, those who have been on previous HCV drug regimens, are expected to take the pill for 12 or 24 weeks, achieving sustained virological response (SVR), an indication that they have been cured.
Original article: People with bleeding disorders and chronic hepatitis C virus (HCV) infection know that the standard weekly interferon injection and daily ribavirin pill can be grueling. Throughout the typical 48-week regimen, patients experience an array of side effects, including feeling like they have the flu. For enduring all that, only 50% clear the virus.
Oral drugs with milder side effects that can be taken for shorter periods are welcome news. Several such medications are now in later-phase clinical trials or awaiting approval by the US Food and Drug Administration (FDA). The goal of future HCV therapy will be to find the right combination of medications, ideally in one pill, without interferon, notorious for causing those troublesome side effects.
In late 2013, the FDA approved two drugs that offer patients hope: Sovaldi™ (sofosbuvir), manufactured by Gilead, and Olysio™ (simeprevir), produced by Janssen Pharmaceuticals, Inc. These treatments are being lauded for their high cure rates—80% to 100%—and their effectiveness in difficult-to-treat patients.
Both drugs are direct-acting antivirals that disrupt critical proteins HCV uses to replicate. Sovaldi is a polymerase inhibitor. It prevents the enzyme polymerase from providing instructions for making copies of HCV building blocks. Olysio is a protease inhibitor. It blocks the protease enzyme from cutting a long protein into smaller functional units that HCV needs to reproduce.
In clinical trials, Sovaldi was effective in people who cannot tolerate interferon. It successfully treated patients with the four major genotypes, or strains, of HCV—1, 2, 3 and 4. Further, it has been FDA-approved for patients with liver cancer who are waiting for a liver transplant and for those co-infected with HCV and HIV. Depending on a patient’s genotype and previous experience with HCV medications, Solvadi in combination with ribavirin only or with an interferon/ribavirin combination needs to be taken for a 12- or 24-week course of therapy—one-quarter to half the time required for the previous standard interferon/ribavirin regimen. When taken with ribavirin alone, common side effects were headache and fatigue. When taken with interferon/ribavirin, patients also experienced nausea, insomnia and anemia.
Olysio has been approved for use in combination with interferon/ribavirin for patients with genotype 1 HCV. It can be taken for 12, 24 or 36 weeks, depending on the patient’s previous experience with other HCV therapies. It is safe for use in patients with compensated liver disease, including cirrhosis. Reported side effects included rash and photosensitivity (increased risk of sunburn).