Through 2016, the FDA approved a range of medications, including 69 new medications or medication formulations, and 10 new indications for existing medications. Of the 69 approvals, 12 new products or medications are indicated to treat conditions related to infectious diseases (Table 1
), and two more such approvals are expected by the end of 2016 (Table 2
). Prominent among these approvals are medications for treatment of infections of hepatitis C virus (HCV), human immunodeficiency virus (HIV), and hepatitis B virus (HBV). Together, medications to treat these infections account for more than half (7) of 12 new infectious disease products approved in 2016.1
On January 28, 2016, Merck’s Zepatier (elbasvir/ grazoprevir) was approved for treatment of chronic HCV genotypes 1 or 4 infection in adults. Zepatier differs from other direct-acting antivirals in that it can be used in patients with any degree of renal impairment, including patients with end-stage renal disease receiving hemodialysis. A course of therapy ranges from 12 to 18 weeks’ duration, and may or may not require use of ribavirin. Use is contraindicated in patients with moderate to severe hepatic impairment, and in patients taking OATP1B1/3 inhibitors (eg, atazanavir, darunavir, lopinavir, saquinavir, tipranavir, and cyclosporine), strong CYP3A inducers, and efavirenz.1,2
Five months after the approval of Zepatier, on June 28, 2016, the FDA approved Gilead’s Epclusa (sofosbuvir/ veltapasvir). Epclusa is unique among direct-acting antivirals in that it is indicated for the treatment of adult patients with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection. The duration of therapy is 12 weeks, either with Epclusa alone (in patients with Child-Pugh class A cirrhosis), or with the combination of Epclusa and ribavirin (in patients with Child-Pugh class B or C cirrhosis). There are no contraindications for use of Epclusa beyond those that apply to ribavirin.1,3
Read more about Epclusa here.
Following Epclusa, on July 22, 2016, the FDA approved AbbVie’s Viekira XR (dasabuvir sodium/ ombitasvir/paritaprevir/ritonavir), which is a once daily formulation of the previously approved twice daily Viekira Pak. Use of Viekira Pak required taking two combination tablets of ombitasvir, paritaprevir, ritonavir in the morning, and one tablet of dasabuvir twice daily, for a total of four tablets daily (three in the morning and one at night). With Viekira XR, the pill burden is reduced to three tablets, administered as a single daily dose. In some patients, Viekira XR must be used with ribavirin. Notably, as ribavirin is typically taken twice daily, the dosing advantage of Viekira XR over Viekira Pak is largely eliminated in these patients.1,4,5
Although the formulation of Viekira has changed, the medication is still approved for use only in patients with genotype 1 HCV infection. Contraindications include use in patients with moderate to severe hepatic impairment (Child-Pugh class B or C cirrhosis); use in patients with a known hypersensitivity to ritonavir; and coadministration with drugs that are highly dependent on CYP3A for clearance, moderate or strong inducers of CYP3A or strong inducers of CYP2C8, or strong inhibitors of CYP2C8.4,5