Matching articles for "Sovaldi"

In Brief: Hepatitis B Reactivation with Direct-Acting Antiviral Drugs for Hepatitis C

   
The Medical Letter on Drugs and Therapeutics • October 24, 2016;  (Issue 1506)
The FDA recently announced that it will require the labeling of all direct-acting antiviral drugs used for treatment of hepatitis C virus (HCV) infection to include a boxed warning about a risk of hepatitis B...
The FDA recently announced that it will require the labeling of all direct-acting antiviral drugs used for treatment of hepatitis C virus (HCV) infection to include a boxed warning about a risk of hepatitis B virus (HBV) reactivation associated with their use.1

Twenty-four cases of HBV reactivation occurring during treatment with direct-acting antiviral drugs for HCV were identified from the FDA Adverse Event Reporting System and the medical literature.2-5 Before starting direct-acting antiviral treatment for HCV, some of these patients were hepatitis B surface antigen (HbsAG) positive and others showed evidence of resolved HBV infection. HBV reactivation generally occurred within 4-8 weeks of starting treatment. Reactivation of HBV can cause increases in bilirubin and aminotransferase levels, fulminant hepatitis, hepatic failure, and death. Of the 24 patients, two died and one required a liver transplant.

HBV reactivation was not identified before FDA approval of these drugs because the clinical trials used to support their approval excluded patients with HBV co-infection. The mechanism by which HBV reactivation occurs during treatment with direct-acting antiviral drugs for HCV is unknown. Patients should be screened for current or past HBV infection before starting treatment with a direct-acting antiviral and monitored for HBV reactivation during and following treatment with these drugs.

  1. FDA Drug Safety Communication: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C. Available at: www.fda.gov. Accessed October 13, 2016.
  2. JM Collins et al. Hepatitis B virus reactivation during successful treatment of hepatitis C virus with sofosbuvir and simeprevir. Clin Infect Dis 2015; 61:1304.
  3. A De Monte et al. Direct-acting antiviral treatment in adults infected with hepatitis C virus: reactivation of hepatitis B virus coinfection as a further challenge. J Clin Virol 2016; 78:27.
  4. AR Ende et al. Fulminant hepatitis B reactivation leading to liver transplantation in a patient with chronic hepatitis C treated with simeprevir and sofosbuvir: a case report. J Med Case Rep 2015; 9:164.
  5. C Wang et al. Hepatitis due to reactivation of hepatitis B virus in endemic areas among patients with hepatitis C treated with direct-acting antiviral agents. Clin Gastroenterol Hepatol 2016 July 5 (epub).


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Med Lett Drugs Ther. 2016 Oct 24;58(1506):140 | Show Full IntroductionHide Full Introduction

Sofosbuvir/Velpatasvir (Epclusa) for Hepatitis C

   
The Medical Letter on Drugs and Therapeutics • August 15, 2016;  (Issue 1501)
The FDA has approved Epclusa (Gilead), a fixed-dose combination of sofosbuvir (Sovaldi) and velpatasvir, a new direct-acting antiviral agent, for oral treatment of chronic hepatitis C virus (HCV) infection....
The FDA has approved Epclusa (Gilead), a fixed-dose combination of sofosbuvir (Sovaldi) and velpatasvir, a new direct-acting antiviral agent, for oral treatment of chronic hepatitis C virus (HCV) infection. Epclusa is the first oral combination to be approved for treatment of all six major HCV genotypes.
Med Lett Drugs Ther. 2016 Aug 15;58(1501):107-8 | Show Full IntroductionHide Full Introduction

Elbasvir/Grazoprevir (Zepatier) for Hepatitis C

   
The Medical Letter on Drugs and Therapeutics • February 29, 2016;  (Issue 1489)
The FDA has approved Zepatier (Merck), a fixed-dose combination of two direct-acting antiviral agents — elbasvir, an NS5A inhibitor, and grazoprevir, an NS3/4A protease inhibitor — for oral treatment of...
The FDA has approved Zepatier (Merck), a fixed-dose combination of two direct-acting antiviral agents — elbasvir, an NS5A inhibitor, and grazoprevir, an NS3/4A protease inhibitor — for oral treatment of chronic hepatitis C virus (HCV) genotype 1 or 4 infection.
Med Lett Drugs Ther. 2016 Feb 29;58(1489):25-7 | Show Full IntroductionHide Full Introduction

Daclatasvir (Daklinza) for HCV Genotype 3 Infection

   
The Medical Letter on Drugs and Therapeutics • October 12, 2015;  (Issue 1479)
The FDA has approved daclatasvir (Daklinza – BMS), an oral direct-acting antiviral drug, for use with sofosbuvir (Sovaldi) for treatment of chronic hepatitis C virus (HCV) genotype 3 infection. Daclatasvir...
The FDA has approved daclatasvir (Daklinza – BMS), an oral direct-acting antiviral drug, for use with sofosbuvir (Sovaldi) for treatment of chronic hepatitis C virus (HCV) genotype 3 infection. Daclatasvir is the first drug approved for this indication that does not require the addition of interferon or ribavirin. It is approved in Japan and Europe in combination with other drugs for treatment of HCV genotypes 1-4.
Med Lett Drugs Ther. 2015 Oct 12;57(1479):142-3 | Show Full IntroductionHide Full Introduction

In Brief: Severe Bradycardia with Sofosbuvir and Amiodarone

   
The Medical Letter on Drugs and Therapeutics • April 13, 2015;  (Issue 1466)
The FDA recently announced changes in the labeling of the hepatitis C drugs Sovaldi (sofosbuvir) and Harvoni (sofosbuvir/ledipasvir) to warn about a risk of serious and potentially fatal bradycardia when either...
The FDA recently announced changes in the labeling of the hepatitis C drugs Sovaldi (sofosbuvir) and Harvoni (sofosbuvir/ledipasvir) to warn about a risk of serious and potentially fatal bradycardia when either drug is taken with the antiarrhythmic drug amiodarone (Cordarone, and others).1 Symptomatic bradycardia was reported following initiation of treatment with Harvoni or with Sovaldi plus simeprevir (Olysio) or the investigational antiviral drug daclatasvir in 9 patients already taking amiodarone; it occurred within 24 hours of starting hepatitis C therapy in 6 patients and within 2-12 days in 3 others. One patient died of cardiac arrest and 3 required pacemaker implantation. In 3 patients who continued taking amiodarone, rechallenge with Harvoni or Sovaldi resulted in recurrence of symptomatic bradycardia. In another patient, rechallenge 8 weeks after stopping amiodarone did not result in bradycardia.

The mechanism of this effect is unknown. Factors possibly contributing to the cardiac events include concomitant beta blocker therapy (in 7 patients) and preexisting cardiac and hepatic disease. Hepatic impairment increases the risk of cardiac conduction abnormalities and could increase adverse effects of amiodarone, which is metabolized by the liver.2 Use of sofosbuvir without amiodarone has not been associated with significant bradycardia.

The new labels warn that sofosbuvir and amiodarone should not be taken concurrently. If concomitant use is necessary, cardiac monitoring in an inpatient setting is recommended for the first 48 hours. Daily monitoring of heart rate, either at home or in an outpatient setting, should continue for at least the first 2 weeks of treatment. Amiodarone has a very long half-life, and its effects may persist for weeks to months after discontinuation.

  1. FDA. FDA Drug Safety Communication: FDA warns of serious slowing of the heart rate when antiarrhythmic drug amiodarone is used with hepatitis C treatments containing sofosbuvir Harvoni or Sovaldi in combination with another direct acting antiviral drug. Available at http://www.fda.gov. Accessed April 2, 2015.
  2. U Klotz. Antiarrhythmics: elimination and dosage considerations in hepatic impairment. Clin Pharmacokinet 2007; 46:985.


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Med Lett Drugs Ther. 2015 Apr 13;57(1466):58 | Show Full IntroductionHide Full Introduction

A 4-Drug Combination (Viekira Pak) for Hepatitis C

   
The Medical Letter on Drugs and Therapeutics • February 2, 2015;  (Issue 1461)
The FDA has approved Viekira Pak (Abbvie), a fixed-dose combination of two new direct-acting antiviral agents (ombitasvir, paritaprevir) with the pharmacologic enhancer ritonavir in one tablet, co-packaged...
The FDA has approved Viekira Pak (Abbvie), a fixed-dose combination of two new direct-acting antiviral agents (ombitasvir, paritaprevir) with the pharmacologic enhancer ritonavir in one tablet, co-packaged with a third new direct-acting antiviral agent (dasabuvir) in a second tablet, for oral treatment of chronic hepatitis C virus (HCV) genotype 1 infection. Genotype 1 is responsible for 70-80% of HCV infections in the US.
Med Lett Drugs Ther. 2015 Feb 2;57(1461):15-7 | Show Full IntroductionHide Full Introduction

A Combination of Ledipasvir and Sofosbuvir (Harvoni) for Hepatitis C

   
The Medical Letter on Drugs and Therapeutics • November 10, 2014;  (Issue 1455)
The FDA has approved a fixed-dose combination (Harvoni [har voe' nee] – Gilead) of sofosbuvir and ledipasvir (led' i pas' vir), two oral direct-acting antiviral agents, for treatment of chronic hepatitis C...
The FDA has approved a fixed-dose combination (Harvoni [har voe' nee] – Gilead) of sofosbuvir and ledipasvir (led' i pas' vir), two oral direct-acting antiviral agents, for treatment of chronic hepatitis C virus (HCV) genotype 1 infection. Genotype 1 is responsible for 70-80% of HCV infections in the US. Sofosbuvir (Sovaldi) was approved earlier for use in combination with other antiviral drugs for treatment of HCV infection. Ledipasvir is a new drug.
Med Lett Drugs Ther. 2014 Nov 10;56(1455):111-2 | Show Full IntroductionHide Full Introduction

Sofosbuvir (Sovaldi) for Chronic Hepatitis C

   
The Medical Letter on Drugs and Therapeutics • January 20, 2014;  (Issue 1434)
The FDA has approved the nucleotide polymerase inhibitor sofosbuvir (Sovaldi – Gilead) for use in combination with other antiviral drugs for treatment of chronic hepatitis C virus (HCV)...
The FDA has approved the nucleotide polymerase inhibitor sofosbuvir (Sovaldi – Gilead) for use in combination with other antiviral drugs for treatment of chronic hepatitis C virus (HCV) infection.
Med Lett Drugs Ther. 2014 Jan 20;56(1434):5-6 | Show Full IntroductionHide Full Introduction

Simeprevir (Olysio) for Chronic Hepatitis C

   
The Medical Letter on Drugs and Therapeutics • January 6, 2014;  (Issue 1433)
The FDA has recently approved 2 new drugs for treatment of chronic hepatitis C virus (HCV) infection. Simeprevir (Olysio – Janssen) is the third oral protease inhibitor to be approved for use in combination...
The FDA has recently approved 2 new drugs for treatment of chronic hepatitis C virus (HCV) infection. Simeprevir (Olysio – Janssen) is the third oral protease inhibitor to be approved for use in combination with peginterferon and ribavirin for treatment of chronic HCV genotype 1 infection in adults with compensated liver disease. Telaprevir (Incivek) and boceprevir (Victrelis) were approved in 2011 for the same indication. Sofosbuvir (Sovaldi – Gilead), a nucleotide analog polymerase inhibitor that has been approved for use with and without interferon for treatment of multiple HCV genotypes, will be reviewed in the next issue of The Medical Letter.
Med Lett Drugs Ther. 2014 Jan 6;56(1433):1-2 | Show Full IntroductionHide Full Introduction