USFDA approves breakthrough drug for hepatitis C.


The nod represents a significant shift in treatment paradigm

The U.S. has approved a breakthrough therapy for treatment of chronic hepatitis C that is expected to offer a more palatable cure to millions of people infected with the liver-destroying viral disease.

Approved by the Food and Drug Administration, the pill, Sovaldi (sofosbuvir) is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon, an official announcement said on Friday.

“Today’s (Friday’s) approval represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C,” said Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

Sovaldi is the second drug approved by the FDA in the past two weeks to treat chronic HCV (hepatitis C virus) infection.

On November 22, the FDA had approved Olysio (simeprevir).

Sovaldi is marketed by Gilead, based in Foster City, California. Olysio is marketed by Raritan, New Jersey-based Janssen Pharmaceuticals.

Clinical trials

The FDA said Sovaldi’s effectiveness was evaluated in six clinical trials consisting of 1,947 participants, who had not previously received treatment for their disease (treatment-naive) or had not responded to previous treatment (treatment-experienced), including participants co-infected with HCV and HIV.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure.

About 3.2 million Americans are infected with hepatitis C, according to the Centers for Disease Control and Prevention, the CNN said.

Symptoms

Symptoms may include fever, fatigue, loss of appetite, vomiting, nausea, abdominal pain, dark urine, clay—coloured bowel movements, joint pain and jaundice, according to the CDC.

The once-a-day pill is the first approved to treat certain types of hepatitis C infection without the need for interferon, an injected drug that can cause severe flu-like symptoms. Hepatitis C, which is often undiagnosed, affects about 3.2 million Americans, killing more than 15,000 each year, mostly from illnesses such as cirrhosis and liver cancer. Most patients will be treated with the $1,000-a-day drug for 12 weeks, resulting in a total list price of $84,000, according to Gilead spokeswoman Cara Miller.

Last year, the CDC recommended that all baby boomers, born from 1945 to 1965, be tested for the virus. Introduction of blood and organ screening in the 1990s has dramatically lowered infection rates for younger generations.

The Gilead drug’s approval was supported by several studies showing that it helped to eradicate the virus in significantly more patients, with fewer side effects, than the current drug regimen.

Sovaldi is the first in a new class of medications known as nucleotide analogue inhibitors, or “nukes,” designed to block a specific protein that the hepatitis C virus needs to copy itself.

Tivicay Approved to Treat HIV-1 Infection.


The US Food and Drug Administration (FDA) today approved a new drug called dolutegravir (Tivicay, GlaxoSmithKline) as an adjunct to other antiretroviral drugs that treat individuals infected with HIV-1, the agency announced.

Dolutegravir, an integrase strand transfer inhibitor, interferes with an enzyme needed for HIV to multiply. It is a once-a-day pill.

The new drug is indicated for HIV-infected adults who have never taken HIV antiretroviral therapy as well as HIV-infected adults who have previously received this therapy, including other integrase strand transfer inhibitors. Clinicians also can order dolutegravir together with other antiretrovirals for children aged 12 years or older, weighing at least 40 kg, who are treatment-naïve or treatment-experienced but have not previously received other integrase strand transfer inhibitors, a restriction not found with adults.

“HIV-infected individuals require treatment regimens personalized to fit their condition and their needs,” said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “The approval of new drugs likeTivicay that add to the existing options remains a priority for the FDA.”

In February, the agency granted priority review status to dolutegravir. Its approval comes 4 days after the FDA okayed the first rapid diagnostic test to spot antibodies to both HIV types 1 and 2 as well as the HIV-1 p24 antigen.

The FDA determined that dolutegravir is safe and effective on the basis of 4 clinical trials involving 2539 participants with HIV. Drug regimens for treating HIV that included dolutegravir proved effective in reducing viral loads, according to the agency. The pharmacokinetics, safety, and activity of the drug with regard to children defined in the pediatric indication were established in a fifth clinical trial.

Insomnia and headache were common adverse events observed in the clinical trials. Among the more serious adverse events were hypersensitivity reactions and abnormal liver functions among patients who also were infected with hepatitis B or C, or both. The drug’s label contains instructions on how to monitor patients for such serious adverse events.

Source: Medscape.com

 

 

 

Source: JAMA

Shocking Story Reveals How the FDA Is Recklessly Abandoning Drug Safety.


In the wake of shocking reports on how the FDA, terrified of being outed for its questionable practices, spied on its own employees in the hopes of rooting them out before they could become whistleblowers, a new story has emerged on how deep the deceit goes. From marginalizing safety reports to not reading them at all―and then going ahead and approving the drugs in question―the FDA once more stands accused of being little more than a rubber-stamping agency for Big Pharma.

Explosive revelations of an intensive spy operation by the FDA on its own scientists emerged last month. Using sophisticated spy software, the agency tracked and logged every move made by the targeted individuals. The program even intercepted personal emails and copied documents on their personal thumb drives.

The targeted scientists had expressed concern over the agency’s approval of dangerous medical imaging devices for mammograms and colonoscopies, which they believe expose patients to dangerous levels of radiation. Now, another whistleblower has stepped forward, and what he has to say about the agency’s drug safety reviews is shocking even to the jaded…

Former FDA Reviewer Speaks Out About Systemic Suppression of Safety

Ronald Kavanagh was a drug reviewer for the FDA in the Center for Drug Evaluation and Research from 1998 to 2008. In a recent interview he reveals how the FDA bypassed or ignored safety issues on major drugs approved during his employment. In an interview for the online news magazine Truth-Out he tells Martha Rosenberg1:

“In the Center for Drugs [Center for Drug Evaluation and Research or CDER], as in the Center for Devices, the honest employee fears the dishonest employee.

There is also irrefutable evidence that managers at CDER have placed the nation at risk by corrupting the evaluation of drugs and by interfering with our ability to ensure the safety and efficacy of drugs. While I was at FDA, drug reviewers were clearly told not to question drug companies and that our job was to approve drugs. We were prevented, except in rare instances, from presenting findings at advisory committees.

In 2007, formal policies were instituted so that speaking in any way that could reflect poorly on the agency could result in termination. If we asked questions that could delay or prevent a drug’s approval – which of course was our job as drug reviewers – management would reprimand us, reassign us, hold secret meetings about us, and worse. Obviously in such an environment, people will self-censor.”

According to Kavanagh, people would be shocked if they knew just how malleable safety data is. As examples, he points out that human studies are typically too short and contain too few subjects to get a clear picture of potential risks. In such a scenario, even a single case of a serious adverse event must be taken very seriously, and data from other longer term safety studies also need to be carefully analyzed. Kavanagh claims he has seen drug reviews where the medical safety reviewer completely failed to make such evaluations prior to the drug’s approval.

Source: By Dr. Mercola