Sofosbuvir improves renal safety in patients with chronic hep C

In continuation of my update on Sofosbuvir

Sofosbuvir-based treatment appears to guarantee renal safety for patients with chronic hepatitis C virus over one year of follow-up, according to a study published online May 7 in the Journal of Clinical Pharmacy and Therapeutics.

Thalia Medeiros, from the Universidade Federal Fluminense in Niterói, Brazil, and colleagues evaluated renal biomarkers among 94 chronic hepatitis C patients treated with sofosbuvir therapy. Urine samples were collected at the end of therapy, after 12 weeks sustained virological response, and one year post-treatment.

The researchers found that 98.9 percent of patients reached sustained virological response. In patients with glomerular filtration rate (GFR) ≥45 mL/min/1.73 m² there was significant improvement in renal biomarkers, as indicated by a progressive increase in mean GFR values until one year. There was no evidence of tubular dysfunction. There was no change in renal biomarkers among patients with baseline GFR <45 mL/min/1.73 m².

"In a 'real-life experience' of a Brazilian center, sofosbuvir therapy appears to guarantee renal safety for patients with chronic hepatitis C followed until one year after treatment," the authors write.

Epclusa Approved for Chronic Hepatitis C

The combination drug Epclusa has been approved by the U.S. Food and Drug Administration to treat the six major strains of chronic hepatitis C virus (HCV).

Epclusa combines sofosbuvir, FDA-approved in 2013, and the new drug velpatasvir. For people with moderate-to-severe cirrhosis (chronic liver disease), Epclusa is approved to be used in combination with the drug ribavirin. Epclusa also is approved for use in people who haven't developed cirrhosis, the agency said Tuesday in a news release.

 sofosbuvir     velpatasvir

HCV causes liver inflammation and diminished liver function. Some 75 percent of Americans with the disease have genotype 1, although there are five other strains. The disease typically becomes chronic, leading to possible complications including bleeding, yellowing of the skin and eyes (jaundice), abdominal fluid accumulation and liver cancer. It could lead to death.

Epclusa was evaluated in clinical trials involving more than 1,500 people. Up to 99 percent of participants given the drug had no virus detected in the blood 12 weeks after treatment, the FDA said.

The most common side effects reported were headache and fatigue.

The drug's label warns that Epclusa, when used with certain other drugs including the heart medication amiodarone, could lead to symptomatic bradycardia, a serious slowing of the heart, the FDA said.

 amiodarone

New triple drug combination shows promise in hepatitis C infected patients: High sustained virologic response achieved with sofosbuvir/velpatasvir and GS-9857, even in patients unsuccessfuly treated with direct-acting antivirals

New data presented today at The International Liver Congress™ 2016 in Barcelona, Spain, demonstrates a high sustained virologic response (SVR) at 12 weeks from the all-oral combination of sofosbuvir/velpatasvir and experimental compound GS-9857 in patients with the Hepatitis C virus (HCV).

 velpatasvir   Sofosbuvir^[

This triple combination treatment was generally safe and effective, even in patients who had been unsuccessfully treated with direct acting antivirals (DAAs, medicines which have been used to treat and cure almost all patients with HCV). The study showed that 99% of patients with HCV genotype 1, 2, 3, 4 and 6 who had previously received treatment, achieved SVR 12 weeks after treatment using this triple combination.

Hepatitis C is a virus carried via the blood, which infects and damages the liver.1 HCV infects liver cells, resulting in inflammation and fibrosis.1 In chronic HCV cases, such symptoms may continue to increase and result in liver cirrhosis, scarring of the liver.1 Despite the high overall SVR rate achieved with currently approved DAA therapies, approximately 5% of patients treated with DAAs will not be cured.2 According to the study authors, for this small proportion of patients who are not cured, retreatment options are significantly limited.

"Our study demonstrates that for HCV patients whose prior treatment has failed with the use of DAAs, this triple combination provides a high rate of sustained virologic response across HCV genotypes," said Dr Eric Lawitz, Clinical Professor of Medicine at the University of Texas Health Science Center, San Antonio and lead author of the study. "Furthermore, the study indicates that the treatment combination is generally safe and well tolerated by patients, providing a promising alternative for HCV sufferers who have limited re-treatment options."

Two global, open-label Phase 2 studies were conducted among chronic HCV-infected patients that had failed prior HCV treatment. Genotype 1 HCV-infected patients enrolled in the study had previously been treated with an NS5A-inhibitor or multiple classes of DAAs, and genotype 2-6 HCV-infected patients had previously been treated with pegylated-interferon (Peg-IFN) plus ribavarin and/or any DAA. All patients received the triple combination of sofosbuvir/velpatasvir plus GS-9857 for 12 weeks. Frequently reported adverse events (AEs) were headache, fatigue, diarrhea and nausea; most were mild or moderate in severity.

"Having offered promising results, this three drug combination is being further evaluated in Phase 3 trials as a single tablet regimen in DAA-experienced patients," said Professor Laurent Castera, EASL Secretary General.

Additional study results

A total of 128 patients were treated: 75% were male, 82% were white, 73% with non-CC IL28B genotypes, and 48% with cirrhosis. 49% of patients had genotype 1, 16% had genotype 2, 27% had genotype 3, 5% had genotype 4 and 2% had genotype 6.

Overall, 27% of patients had been previously treated with NS5A-inhibitors, 52% had been previously treated with other DAAs, and 21% had failed interferon-based treatment without a DAA. Baseline resistance-associated variants (RAVs) were detected in 60% of patients (20% with RAVs to NS5A-inhibitors and 23% with RAVs to multiple classes).

The most commonly reported AEs (&gt;10%) were headache, fatigue, diarrhea, and nausea; most were mild or moderate in severity. One patient (&lt;1%) experienced a serious AE of gastroenteritis (&lt;1%) and 1 patient discontinued treatment early due to an AE of gastritis at Week 9 and achieved SVR12; both AEs were not considered related to the study drugs. No clinically significant laboratory abnormalities were observed

New triple drug combination shows promise in hepatitis C infected patients: High sustained virologic response achieved with sofosbuvir/velpatasvir and GS-9857, even in patients unsuccessfuly treated with direct-acting antivirals  

FDA Approves Expanded Use of Daklinza (daclatasvir) for Additional Challenging-to-treat Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C

In continuation of my update on daclatasvir

Bristol-Myers Squibb Company (NYSE:BMY) announced today that Daklinza (daclatasvir, 60 mg), an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3. The expanded label includes data in three additional challenging-to-treat patient populations: chronic hepatitis C virus (HCV) patients with HIV-1 coinfection, advanced cirrhosis, or post-liver transplant recurrence of HCV. The Daklinza plus sofosbuvir regimen is already available for the treatment of chronic HCV genotype 3, and is currently the only 12-week, once-daily all-oral treatment option for these patients. Sustained virologic response (SVR) rates are reduced in genotype 3 patients with cirrhosis receiving Daklinza and sofosbuvir for 12 weeks without ribavirin. The recommended dosage of Daklinza is 60 mg in combination with sofosbuvir with or without (+/-) ribavirin for 12 weeks.

FDA Approves Expanded Use of Daklinza (daclatasvir) for Additional Challenging-to-treat Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C

FDA Approves Two Supplemental Indications for Harvoni in Chronic Hepatitis C Patients With Advanced Liver Disease

In continuation of my update on Harvoni (ledipasvir/sofosbuvir)

Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved additional indications for Harvoni (ledipasvir/sofosbuvir) for use in chronic hepatitis C patients with advanced liver disease. Harvoni in combination with ribavirin (RBV) for 12 weeks was approved for use in chronic hepatitis C virus (HCV) genotype 1- or 4-infected liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and for HCV genotype 1-infected patients with decompensated cirrhosis (Child-Pugh B or C), including those who have undergone liver transplantation. Harvoni is now approved for use in a broader range of patient populations, including HCV genotypes 1, 4, 5 and 6, HCV/HIV-1 coinfection, HCV genotype 1 and 4 liver transplant recipients, and genotype 1-infected patients with decompensated cirrhosis..

FDA Approves Two Supplemental Indications for Harvoni in Chronic Hepatitis C Patients With Advanced Liver Disease

FDA Approves Expanded Use of Daklinza (daclatasvir) for Additional Challenging-to-treat Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C

In continuation  of my update on Daclatasvir

Bristol-Myers Squibb Company (NYSE:BMY) announced today that Daklinza (daclatasvir, 60 mg), an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3. The expanded label includes data in three additional challenging-to-treat patient populations: chronic hepatitis C virus (HCV) patients with HIV-1 coinfection, advanced cirrhosis, or post-liver transplant recurrence of HCV. The Daklinza plus sofosbuvir regimen is already available for the treatment of chronic HCV genotype 3, and is currently the only 12-week, once-daily all-oral treatment option for these patients. Sustained virologic response (SVR) rates are reduced in genotype 3 patients with cirrhosis receiving Daklinza and sofosbuvir for 12 weeks without ribavirin. The recommended dosage of Daklinza is 60 mg in combination with sofosbuvir with or without (+/-) ribavirin for 12 weeks..

“The expanded indication for Daklinza offers an additional treatment option for multiple subsets of patients who have genotype 1 or 3 chronic HCV,” said Chris Boerner, Head of U.S. Commercial, Bristol-Myers Squibb. “HCV/HIV-coinfected patients and patients with advanced cirrhosis or post-transplant recurrence of HCV still pose a treatment challenge to physicians. As part of our commitment to the HCV community, we have sought to make new treatment options available for these and other targeted populations that have not yet been able to fully benefit from currently available next-generation medicines.”

FDA Approves Expanded Use of Daklinza (daclatasvir) for Additional Challenging-to-treat Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C

EC approves expanded use of Daklinza (daclatasvir) for patients with chronic HCV and HIV co-infection

Daclatasvir formerly BMS-790052, trade name Daklinza) is a drug for the treatment of hepatitis C (HCV). It was developed by Bristol-Myers Squibb and was approved in Europe on 22 August 2014. Daklinza gained its FDA approval on July 24, 2015 in the United States; it is approved for Hepatitis C genotype 3 infections.  

A generic version of daclatasvir is expected to be approved in India before the end of 2015. 

Daclatasvir inhibits the HCV nonstructural protein NS5A.  Recent research suggests that it targets two steps of the viral replication process, enabling rapid decline of HCV RNA. Daclatasvir has been tested in combination regimens with pegylated interferon and ribavirin,  as well as with other direct-acting antiviral agents including asunaprevir and sofosbuvir....

Now....

EC approves expanded use of Daklinza (daclatasvir) for patients with chronic HCV and HIV co-infection: Bristol-Myers Squibb today announced that the European Commission has approved the expanded use of Daklinza, a first-in-class oral, once-a-day pill used in combination with other treatments as an option for adult patients with chronic hepatitis C virus infection who are co-infected with HIV or who have had a prior liver transplant.

New drug combination may reduce need for complex regimens to treat hepatitis C

In continuation of my update on sofosbuvir

  

The prognosis for people with hepatitis C has improved dramatically in the last few years, thanks to the introduction of direct-acting anti-viral medications, including Harvoni (the brand name for a combination of ledipasvir and sofosbuvir) and Viekira Pack (a mix of ombitasvir, paritaprevir, ritonavir and dasabuvir). These drugs — which block the hepatitis C virus from multiplying — boast cure rates of better than 90 percent. In addition, they are well-tolerated in most patients, causing only minor side effects.

Despite these major advances, the quest for better hepatitis C medications is not yet over. Drug makers continue to test new drugs to overcome limitations in treating this virus, which can cause liver cirrhosis (or scarring) and failure. About 2.7 million people in the U.S. are infected with the virus, with nearly 30,000 cases occurring in 2013 alone, according to the Centers for Disease Control and Prevention.

"The current medicines are very effective, but physicians sometimes have to tailor the regimen or the length of treatment based on patient characteristics, such as whether the patient has liver cirrhosis or has failed prior therapy," says Nancy S. Reau, MD, chief of the Section of Hepatology at Rush University Medical Center.

Another treatment factor is the type of hepatitis C a patient has. The virus has six different strains, called genotypes.

Now a simplified way of treating all hepatitis C patients may be approaching. Reau participated in a phase III clinical trial of a combination of Solvadi (sofosbuvir) with the investigational drug velpatasvir on patients with genotypes two and three. As described in an article published online on Nov. 17 in the New England Journal of Medicine, the study found that 12 weeks of sofosbuvir-velpatasvir produced higher cure rates in patients with these two genotypes — including those who had cirrhosis or had failed older treatments — than a similar therapy (sofosbuvir-ribavirin)

New drug combination may reduce need for complex regimens to treat hepatitis C

FDA Approves Olysio (simeprevir) in Combination with Sofosbuvir for Genotype 1 Chronic Hepatitis C Infection

In continuation of my update on Sofosbuvir (left) and  Simeprevir (right)

Janssen Therapeutics, Division of Janssen Products, LP (Janssen) announced the U.S. Food and Drug Administration (FDA) has approved Olysio (simeprevir), a hepatitis C virus (HCV) NS3/4A protease inhibitor, in combination with sofosbuvir as an all-oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis C (CHC) infection in adult patients as part of a combination antiviral treatment regimen. Sofosbuvir is an HCV nucleotide analog NS5B polymerase inhibitor developed by Gilead Sciences, Inc.

FDA Approves Olysio (simeprevir) in Combination with Sofosbuvir for Genotype 1 Chronic Hepatitis C Infection

FDA Approves Olysio (simeprevir) in Combination with Sofosbuvir for Genotype 1 Chronic Hepatitis C Infection

In continuation of my update on sofosbuvir

Janssen Therapeutics, Division of Janssen Products, LP (Janssen) announced the U.S. Food and Drug Administration (FDA) has approved Olysio (simeprevir), a hepatitis C virus (HCV) NS3/4A protease inhibitor, in combination withsofosbuvir as an all-oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis C (CHC) infection in adult patients as part of a combination antiviral treatment regimen. Sofosbuvir is an HCV nucleotide analog NS5B polymerase inhibitor developed by Gilead Sciences, Inc.

FDA Approves Olysio (simeprevir) in Combination with Sofosbuvir for Genotype 1 Chronic Hepatitis C Infection

Harvoni Approved for Chronic Hepatitis C

In continuation of my update on  ledipasvir and sofosbuvir (Harvoni-combination pill) 

Harvoni, a daily pill that treats the most common form of hepatitis C, was approved by the U.S. Food and Drug Administration on Friday.

It's the first combination pill (ledipasvir and sofosbuvir) approved to treat the chronic infection, and the first medication that doesn't require that the antiviral drugs interferon or ribavirin be taken at the same time, the FDA said in a news release.

Both drugs in the combination pill interfere with the hepatitis C virus' ability to multiply. One of the drugs, sofosbuvir (Sovaldi) was approved in December 2013, while ledipasvir is a new antiviral, the agency said.

"With the development and approval of new treatments for hepatitis C virus, we are changing the treatment paradigm for Americans living with the disease," Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in the news release. "Until last year, the only available treatments for hepatitis C virus required administration with interferon and ribavirin. Now, patients and health care professionals have multiple treatment options, including a combination pill to help simplify treatment regimens."

One expert applauded Harvoni's approval.

"This is a giant step forward for people with [hepatitis C]. One pill, once daily, no interferon, no ribavirin and 94 to 99 percent cure! It moves the risk-benefit ratio needle way over toward benefit," said Dr. Douglas Dieterich, a professor of medicine in the division of liver diseases at The Mount Sinai Hospital in New York City.

However, price has been an issue with some of the new treatments for hepatitis C. For example, Sovaldi alone costs $1,000 a day and not all insurance companies cover the cost of treatment, experts have noted. Harvoni will cost $1,125 a pill, the Associated Press reported Friday.

Hepatitis C causes inflammation of the liver, which could spark other problems including diminished liver function (cirrhosis), scarring, liver cancer or liver failure. Most infected people aren't aware that they carry the virus until liver damage has occurred, the agency said.

Some 3.2 million Americans are believed to be infected with hepatitis C, the FDA said.

Harvoni was evaluated in three clinical studies involving more than 1,500 people who either hadn't been treated previously or hadn't responded to prior treatment. The most common side effects were fatigue and headache.

Harvoni Approved for Chronic Hepatitis C  

New combination drug therapy proves very effective in hepatitis C treatments

A new 12-week single tablet regimen of ledipasvir and sofosbuvir have proven to be highly effective in treating a broad range of patients with HCV genotype 1, a form of the virus found in up to 75 percent of infections, according to results unveiled today at the European Association for the Study of the Liver and published simultaneously online by the New England Journal of Medicine.

Between 94 percent and 99 percent of patients were cured of hepatitis C and results were similar in patients who have never been treated and for those who had previously been treated with a combination of peginterferon and ribavirin, the current course that carries sometimes significant side effects.

“Eliminating interferon and ribavirin from treatment regimens is expected to reduce the incidence and severity of adverse events, to simplify the treatment of patients with HCV infection and to provide an option for patients who are ineligible for the current interferon-based treatments,” said Nezam Afdhal, MD, the senior author of the studies, Director of the Liver Center at Beth Israel Deaconess Medical Center and a Professor of Medicine at Harvard Medical School.

Hepatitis C is an infectious disease primarily affecting the liver and which can lead to scarring and cirrhosis and is transmitted primarily through blood transfusions (prior to 1991), intravenous drug use, poorly sterilized medical equipment and sexual transmission.. After exposure 80 percent of patients develop a chronic hepatitis which can lead to cirrhosis, liver failure and liver cancer and hepatitis C is the most common cause for liver transplantation in the US.

Prior treatments have been with interferon which is an injectable cytokine released in response to viral infections. Interferon is combined with other antiviral agents and needs to be used for up to 48 weeks to cure hepatitis C. but is associated with number of side effects, including influenza-like symptoms depression and anemia. Many patients are ineligible for these interferon-based therapies.

“The real advances seen in the Ion trials is that the sofosbuvir-ledipasvir combination tablet enables us to treat almost all genotype 1 patients with a short duration of 8-12 weeks of treatment expanding the treatment pool and increasing the overall cure rate,” said Afdhal.

New combination drug therapy proves very effective in hepatitis C treatments

New Hepatitis C Drug Sovaldi Approved by FDA

A new hepatitis C drug that can be taken as a pill once a day was approved by the U.S. Food and Drug Administration on Friday.

The drug, called Sovaldi and made by Calif.-based Gilead Sciences Inc., works faster and should be much simpler to take for the millions of Americans who have the virus, which can destroy the liver if left untreated.

The FDA said in a statement that Sovaldi is to be taken with older drugs to treat the main forms of hepatitis C. The agency added that 3.2 million Americans have the disease, and people born between 1945 and 1965 are five times more likely to be infected.

Current treatments can take almost a year to beat back the virus, and involve weekly injections of the drug interferon, which can cause diarrhea and flu-like symptoms, the FDA said. Only about 75 percent of patients are cured with current treatments. In clinical trials, Sovaldi cured close to 90 percent of patients in just 12 weeks, when combined with the standard treatment.

Sovaldi (sofosbuvir) is the second hepatitis C drug to be approved by the FDA in the past two weeks. In November, the agency gave its blessing to Olysio (simeprevir), made by Janssen Pharmaceuticals, of Raritan, N.J.

Symptoms of hepatitis C disease may not appear until two or three decades after infection, though the virus can cause liver failure, cirrhosis and cancer, the FDA said.

New Hepatitis C Drug Sovaldi Approved by FDA - Drugs.com MedNews

Investigational oral regimen for hepatitis C shows promise

In a study of an all-oral drug regimen, a majority of volunteers with liver damage due to hepatitis C virus (HCV) infection were cured following a six-month course of therapy that combined an experimental drug, sofosbuvir, with the licensed antiviral drug ribavirin. The results showed that the regimen was highly effective in clearing the virus and well tolerated in a group of patients who historically have had unfavorable prognoses.

Investigational oral regimen for hepatitis C shows promise