Sorafenib tosylate, Ribavirn and Sofosbuvir combination therapy for HCV virus infected patients with decompensated liver cancer

Pak J Pharm Sci. 2017 Nov;30(6(Supplementary)):2383-2387.

Abstract

Hepatitis C is the most common health problem worldwide and is major cause of death due to proliferation of hepatocellular carcinoma. The medicines available for HCV treatment overcome up-to 95% complications of HCV. However, liver cancer needs some additional care. Normally Sorafenib tosylate 200 mg is recommended for liver cancer. There is no such trial in which this drug could effectively be used in combination of direct acting antivirals for HCV. The study was conducted for HCV patients (n=30) with liver cancer having decompensated stage. Combination of Sorafenib tosylate, Ribavirn and Sofosbuvir were used for the pharmacokinetics of these medicines. Child pugh score less then 7 (CP A) in adults during treatment phase (received 12 weeks of Sorafenib tosylate 200 mg, Ribavirn and Sofosbuvir 400 mg once daily) have no side effect while child pugh score 7-9 (CP B) have evidence of hypertension. The main efficiency end point sustained virology response with overcoming liver cancer as well in 12 weeks after end treatment (SVR-LLC 12). Mean pharmacokinetic exposure to Sorafenib tosylate 200 mg, Ribavirn and Sofosbuvir at week 8th was 2.1, 1.5,1.2 times greater in CP B than in CP A. Adverse effects (AEs) were observed in 12 out of 30 patients but not severe as lethal for life. Treatment with Sorafenib tosylate, Ribavirn and Sofosbuvir for twelve weeks was harmless and well accepted, 100 % patients achieve (SVR LLC 12) with 10-fold cure rate more than previous ones. The combination therapy of Sorafenib tosylate, Ribavirn and Sofosbuvir was found helpful for the management of decompensated liver cancer.

MeSH terms

  • Adult
  • Aged
  • Carcinoma, Hepatocellular / diagnosis
  • Carcinoma, Hepatocellular / drug therapy*
  • Carcinoma, Hepatocellular / virology
  • Drug Therapy, Combination
  • Female
  • Hepatitis C / diagnosis
  • Hepatitis C / drug therapy*
  • Hepatitis C / virology
  • Humans
  • Liver Neoplasms / diagnosis
  • Liver Neoplasms / drug therapy*
  • Liver Neoplasms / virology
  • Male
  • Middle Aged
  • Ribavirin / adverse effects
  • Ribavirin / pharmacokinetics
  • Ribavirin / therapeutic use*
  • Sofosbuvir / adverse effects
  • Sofosbuvir / pharmacokinetics
  • Sofosbuvir / therapeutic use*
  • Sorafenib / adverse effects
  • Sorafenib / pharmacokinetics
  • Sorafenib / therapeutic use*
  • Sustained Virologic Response
  • Treatment Outcome

Substances

  • Ribavirin
  • Sorafenib
  • Sofosbuvir