The United States Food and Drug Administration has approved Sovaldi (Sofosbuvir) for the treatment of chronic hepatitis C virus (HCV) infection. Sovaldi is the first drug that demonstrated the efficacy against certain HCV infections with co-administration of interferon. Sovaldi is the second approved drug in the last one month after Olysio (Simeprevir) approval. The drug is to be marketed by Gilead, USA.
The nucleotide analog inhibitor blocks specific protein that is vital for HCV replication. Sovaldi can be administered as a combined therapy for chronic HCV infection. The treatment strategy depends on the type of infection. The treatment regimen should including either Ribavirin with Sovaldi or Peginterferon-alpha with Sovaldi and Ribavirin.
According to Dr. Edward Cox, Director, Office of the Antimicrobial Products, Center for Drug Evaluation and Research, USFDA, the approval of Sovaldi has represented a significant shift in existing treatment paradigm among HCV patients.
Six clinical trials were conducted involving 1947 patients to assess the safety and efficacy of Sovaldi. The participants were either treatment-naïve or unresponsive to existing therapies. The participants were co-infected with HIV. The endpoints of the study are undetectable levels of viral load after 12 weeks of treatment.
The treatments were effective against multiple strains of HCV. Significant efficacy was observed among interferon-intolerant patients and who need to undergo liver transplantation.
Some of the commonly reported adverse events of Sovaldi and Ribavirin treatment are headache and fatigue. Common adverse events of Sovaldi and Ribavirin with Peginterferon-alpha are insomnia, headache, nausea, general weakness and anemia.
Sovaldi was approved with breakthrough drug designation, the third drug to receive the status. Sovaldi was approved based on USFDA’s priority review program and approved within six months of NDA (new drug application) filing by the manufacturer/sponsor.