Since 2007, more people have died every year from hepatitis C than from HIV. Fortunately, the latest hepatitis C medications can cure nearly everyone in a relatively quick, easy fashion. So, if it is so easy to cure hepatitis C, why haven't we?
Ostensibly, it is because of the cost. At $1125 a pill for Gilead Sciences' drug Harvoni, a 12-week course of hepatitis C treatment would amount to $94,500. Trying to manage these costs, many state Medicaid programs and insurance companies have severely restricted access to treatment. You save money if you deny treatment to people, and dead people cost nothing.
This means that although we can cure hepatitis C, we aren't. Under many insurance plans, patients have to prove that they have cirrhosis. In short, treatment is approved when liver damage has progressed to its worst stage. It is like refusing to pay for diabetes drugs until the patient is blind or minus a few toes.
Read more....
Thursday, September 17, 2015
Achillion Reports 100% SVR12 From Second Cohort of Patients in the Previously-Completed Six Week Phase 2 Trial Evaluating Odalasvir (ACH-3102) and Sofosbuvir for Genotype 1 HCV ("Proxy Study")
- 100% SVR12 reported for all patients treated for six- (n=18) or eight-weeks (n=12) —
- Odalasvir (ACH-3102) is the subject of an exclusive, worldwide development and commercialization license granted to Janssen -
NEW HAVEN, Conn., Sept. 17, 2015 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced additional interim results from a Phase 2 study evaluating odalasvir (also known as ACH-3102), a NS5A inhibitor, in combination with sofosbuvir, without ribavirin, for either six or eight weeks of treatment in patients with treatment-naïve genotype 1 chronic hepatitis C virus (HCV) infection. Of the patients treated for six weeks in this cross-over cohort, 100 percent (n=6/6) remained HCV RNA undetectable twelve weeks after completing therapy (SVR12). Previously, Achillion reported results from this study including 100 percent SVR24 for the initial cohorts including 12 patients treated for eight weeks and 100 percent SVR24 for 12 patients treated for six weeks.
In May 2015, Achillion announced it had granted Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets which include odalasvir, ACH-3422, and sovaprevir.
ACH-3102 - 017: Phase 2 pilot study evaluating six- and eight-weeks of treatment in combination with sofosbuvir for genotype 1 treatment-naïve HCV
Achillion conducted a Phase 2, open-label, randomized, partial-crossover study to evaluate the efficacy, safety, and tolerability of eight weeks or six weeks of odalasvir and sofosbuvir, a marketed nucleotide polymerase inhibitor, without ribavirin, in treatment-naïve genotype 1 HCV-infected patients. The primary objective of the study was determination of sustained viral response 12 weeks (SVR12) after the completion of therapy. Eighteen patients were initially enrolled, including six observational patients (group 1). Twelve patients completed eight weeks of treatment consisting of 50 mg of odalasvir and 400 mg of sofosbuvir administered once daily while observational patients received no drug during this phase of the trial. Ten of the 12 patients receiving eight weeks of treatment had genotype 1a HCV. At baseline, the median HCV RNA was 7.15 log10 (range 5.5 — 7.8 log10). Of the 12 patients, 100 percent achieved SVR24. Odalasvir and sofosbuvir were well tolerated with no significant adverse events, ECG findings, or lab abnormalities observed during treatment.
Following achievement of the pre-specified response rate of 100 percent, the six observational patients plus six additional patients (group 2) were enrolled and received six weeks of treatment consisting of 50 mg of odalasvir and 400 mg of sofosbuvir administered once daily. Median HCV RNA at baseline was 6.95 log10 (range 6.2 — 8.0 log10) and six patients had GT 1a HCV. Of the 12 patients, 100 percent achieved SVR24.
Six additional rollover patients (group 3), enrolled into the final cohort, also received six weeks of treatment consisting of 50 mg of odalasvir and 400 mg of sofosbuvir administered once daily. Baseline characteristics included five of six patients with genotype 1a HCV, four of six patients with non-CC IL28B (two patients with IL28B TT), and a median baseline HCV RNA of 6.32 log10 IU/ml (range 6.0 — 7.3 log10 IU/ml). In all, a total of 18 patients (group 2 and 3) received six weeks of treatment and all subjects, 100 percent, achieved SVR12.
About the Achillion Worldwide HCV Collaboration with Janssen
On May 19, 2015, Achillion announced it had granted Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets which include odalasvir (ACH-3102), ACH-3422, and sovaprevir. A key objective of the collaboration is to develop a short-duration, highly effective, pan-genotypic, oral regimen for the treatment of HCV. Achillion announced on August 3, 2015 that Alios Biopharma Inc., part of the Janssen Pharmaceutical Companies (Janssen) had initiated a Phase 1 clinical trial to evaluate the potential effect of simeprevir and odalasvir on the pharmacokinetics of AL-335 in healthy volunteers. Janssen previously stated its goal of initiating Phase 3 development with a triple regimen for HCV by early 2017.
About HCV
The hepatitis C virus (HCV) is one of the most common causes of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 150 million people are infected with HCV worldwide including more than 5 million people in the United States. Three-quarters of the HCV patient population is undiagnosed; it is a silent epidemic and a major global health threat. Chronic hepatitis, if left untreated, can lead to permanent liver damage that can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection.
About Achillion Pharmaceuticals
Achillion is seeking to apply its expertise in biology and structure-guided design and a deep understanding of patient and clinician needs to develop innovative treatment solutions aimed at improving patients' lives. Achillion believes that its scientific excellence, integrated capabilities and experienced team position it to successfully achieve its goal of advancing new products along the entire continuum from the bench to the patient. Achillion's pipeline is currently focused on small molecule therapeutics for infectious disease and complement-related diseases. www.achillion.com
Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other important factors that could cause actual results to differ materially from those indicated by such forward-looking statements. Achillion may use words such as "expect," "anticipate," "project," "intend," "plan," "aim," "believe," "seek," " estimate," "can," "focus," "will," and "may" and similar expressions to identify such forward-looking statements. Among the important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are risks relating to, among other things Achillion's ability to: comply with its obligations under and otherwise maintain its collaboration agreement with Janssen on the agreed upon terms; demonstrate, either alone or through its collaborators, the requisite safety, efficacy and combinability of its drug candidates, and advance the preclinical and clinical development of its drug candidates under the timelines it projects in current and future clinical trials; obtain and maintain necessary regulatory approvals; obtain and maintain patent protection for its drug candidates and the freedom to operate under third party intellectual property; establish commercial manufacturing arrangements; identify, enter into and maintain collaboration agreements with appropriate third-parties; compete effectively and successfully; manage expenses; manage litigation; raise the substantial additional capital needed to achieve its business objectives; and successfully execute on its business strategies. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2014, its quarterly report on Form 10-Q for the quarter ended June 30, 2015, and its subsequent SEC filings.
In addition, any forward-looking statement in this press release represents Achillion's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Achillion disclaims any duty to update any forward-looking statement, except as required by applicable law.
Company Contact:
Glenn Schulman
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
gschulman@achillion.com
Investors:
Mary Kay Fenton
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
mfenton@achillion.com
Investors:
Tricia Truehart
The Trout Group, LLC
Tel. (646) 378-2953
ttruehart@troutgroup.com
3-Drug Therapy Deemed Effective Hepatitis C Treatment
An investigational combination of 3 interferon-free drugs has proven effective at treating hepatitis C virus (HCV) in a recent trial. The study, published in the Journal of the American Medical Association, examined a 12-week dose of daclatasvir, asunaprevir, and beclabuvir in patients with HCV-related liver cirrhosis. None of the 3 medications has yet been approved for use in the United States, although daclatasvir is currently under review by the FDA.
The researchers found that the combination cleared HCV in 93% of trial participants who had not been previously treated, as well as in 87% of those with past failed therapies. However, the addition of a fourth drug, ribavirin, increased the cure rate of patients with past failed therapies to 93%, comparable to that of patients who were receiving treatment for the first time.
“The development of interferon-free treatments has been a tremendous step forward in the standard of care,” said lead author Andrew Muir, MD, MHS, in a press release. “These drugs are highly effective and well tolerated by patients at all stages of liver disease.”
Read more.....
The researchers found that the combination cleared HCV in 93% of trial participants who had not been previously treated, as well as in 87% of those with past failed therapies. However, the addition of a fourth drug, ribavirin, increased the cure rate of patients with past failed therapies to 93%, comparable to that of patients who were receiving treatment for the first time.
“The development of interferon-free treatments has been a tremendous step forward in the standard of care,” said lead author Andrew Muir, MD, MHS, in a press release. “These drugs are highly effective and well tolerated by patients at all stages of liver disease.”
Read more.....
Wednesday, September 16, 2015
Image of the Week: Gamification Approach Educates Delegates at World Hepatitis Summit
Earlier this month, MCI worked with the World Health Organization (WHO), the Scottish Government and the World Hepatitis Alliance to deliver the first ever World Hepatitis Summit in Glasgow, Scotland.
A key objective for the three-day programme was to help attendees – a mix of government officials, healthcare professionals and patient representatives – realise how to form a national plan should an outbreak of hepatitis happen.
MCI’s creative team knew that engaging the audience through an immersive experience would be more effective than simply presenting facts and figures, so created an experiential session that inspired attendees to think on their feet and gain practical skills in terms of assessing the level of threat to their countries and preparing a National Plan for Hepatitis.
Read more....
A key objective for the three-day programme was to help attendees – a mix of government officials, healthcare professionals and patient representatives – realise how to form a national plan should an outbreak of hepatitis happen.
MCI’s creative team knew that engaging the audience through an immersive experience would be more effective than simply presenting facts and figures, so created an experiential session that inspired attendees to think on their feet and gain practical skills in terms of assessing the level of threat to their countries and preparing a National Plan for Hepatitis.
Read more....
Benitec Initiates a Fourth Site in Hepatitis C Clinical Trial
SYDNEY, Sept. 16, 2015 /PRNewswire/ -- Benitec Biopharma Limited (NASDAQ: BNTC; NASDAQ: BNTCW; ASX: BLT) a clinical-stage biotechnology company developing innovative therapeutics based on its gene-silencing technology, DNA-directed RNA interference (ddRNAi), is pleased to announce it has initiated a new site for its ongoing Phase 1/2a TT-034 trial at the Methodist Health System Clinical Research Institute in Dallas, Texas. The site has commenced pre-screening hepatitis C patients and is led by principal investigator Dr. Parvez Mantry, a gastroenterologist and hepatologist.
This brings the total number of trial sites to four, with Benitec already having established sites at the Duke Clinical Research Institute, the University of California San Diego and the Texas Liver Institute.
Benitec CEO and Managing Director Dr. Peter French said, "We are pleased to welcome a fourth site to join our first-in-man trial of TT-034, an innovative therapeutic based on Benitec's gene silencing technology, ddRNAi. The addition of this site reflects the growing interest from the medical community in Benitec's potentially transformational approach to treating and curing hepatitis C. Recruitment and dosing for the trial is proceeding well."
More detail on the TT-034 trial: TT-034 is a ddRNAi-based therapeutic, designed to treat and potentially cure hepatitis C (HCV) with a single administration. TT-034 targets the hepatitis C viral RNA at three separate, highly conserved sites. As such it acts as a "triple therapy" even though it is a monotherapy, and minimises the ability of the virus to mutate and escape the therapy. Once it reaches the liver cells it enters the nucleus and produces three separate short hairpin RNAs continuously for the lifetime of the cell. Thus it has the potential to not only treat the existing HCV infection but to guard against reinfection for months to years without the need to re-treat. It has been extensively tested in pre-clinical in vivo studies and no adverse effects were seen at any therapeutic dose. However, as it is regulated as a gene therapy, the trial design is to primarily ensure that treatment with TT-034 is safe, hence the gradual dose escalation.
Read complete press release here: http://www.prnewswire.com/news-releases/benitec-initiates-a-fourth-site-in-hepatitis-c-clinical-trial-300143931.html
Tuesday, September 15, 2015
Medical Office Responsible For Transmitting Hepatitis C To Patients Can Reopen
The Santa Barbara medical office of Dr. Allen Thomashefsky may reopen after it was shut down for unsafe injection practices.
The Public Health Department for Santa Barbara County released the following statement:
"Santa Barbara County Health Officer, Charity Dean, MD, MPH, has rescinded the Health Officer Order closing the medical office of Dr. Allen Thomashefsky. This action follows a number of measures that have been implemented to assure infection control practices are maintained at the medical office.
Genetic testing of Dr. Thomashefsky's former patients revealed at least four people who had procedures at his office the same day tested positive for Hepatitis C. A fifth may have contracted the deadly disease prior to treatment.
Read more...
The Public Health Department for Santa Barbara County released the following statement:
"Santa Barbara County Health Officer, Charity Dean, MD, MPH, has rescinded the Health Officer Order closing the medical office of Dr. Allen Thomashefsky. This action follows a number of measures that have been implemented to assure infection control practices are maintained at the medical office.
Genetic testing of Dr. Thomashefsky's former patients revealed at least four people who had procedures at his office the same day tested positive for Hepatitis C. A fifth may have contracted the deadly disease prior to treatment.
Read more...
Hepatitis C in Children
—Alan Franciscus, Editor-in-Chief
It is estimated that Hepatitis C (HCV) occurs in about 0.15% of 6-11 year-olds and 0.4% of 12-19 year-olds. It is estimated that there are 23,000 to 46,000 children in the US with HCV.1 The actual number of children with HCV is unknown because children are not routinely tested for it.
Prior to 1992, the most common transmission route for HCV in children was through blood transfusion, blood products, and organ transplantation. Now that blood products and organs are screened for hepatitis C the most frequent transmission of hepatitis C in infants is mother-to-child transmission. The second most common transmission route in children and teenagers is in those who share equipment to inject drugs (needles, cookers, cotton, water, etc.)
Transmission of HCV from an HCV-infected mother-to-infant occurs about 6% of the time. It can occur up to 10% of the time if a mother is coinfected with HIV and hepatitis C. Also, a high viral load increases the risk of mother-to-infant transmission. Unfortunately, there are no effective strategies or drugs to prevent the transmission of HCV from mother to child.
When a baby is born to an HCV-infected mother, the child will acquire the mother’s HCV antibodies. For this reason, the child will not be tested for HCV antibodies for 18 months. This is the period that it takes for the baby’s body to clear out the mother’s antibodies.
An HCV RNA or viral load test can be given as early as one month. It might be too early since the HCV RNA, or viral load fluctuates during the acute infection phase. Also, babies have a high rate of natural clearance. Most medical providers prefer to wait out the 18-month period to test for HCV antibodies and the confirmatory HCV RNA (viral load test).
Table 1. Children for whom screening is recommended.
Diagnosis and management of hepatitis C infection in infants, children, and adolescents Pediatric Gastroenterol, Nutr 2012;54:838-855
Baker R. Viral Hepatitis. In: Pohl JF, editor. Pediatric Gastroenterology. Baton Rougue, FL: CRC Press: 2014. pp 313-327
*I read this recommendation with interest because we know that receiving a tattoo or piercing in a commercial parlor is safe. .
Chronic Infection
Approximately 75% of infants who are acutely infected with hepatitis C will continue to chronic infection. In children, the rate of disease progression is slow. There is, however, a small percentage (estimated at less than 2%) of children in whom there is a rapid rate of disease progression that could lead to fibrosis and cirrhosis.
Watch, Wait and Protect
A baby born to an HCV-infected mother should receive the hepatitis A and hepatitis B vaccines to protect the child from becoming infected with another liver disease. As well the baby and child should receive other immunizations to protect the health of the child.
Hepatitis C is not spread by casual contact and infected children should not be restricted from attending daycare or school. Children should be taught that they should not share toothbrushes, nail clippers, razors or any other items that have the potential to transmit hepatitis C.
Any drug, herb or supplement that the child is given should be screened to make sure that it is liver safe. When the child is older, a discussion should take place about sex, drugs, and alcohol.
Most importantly, a child should be medically monitored on a regular basis.
When to Tell a Child
Telling a child that they have hepatitis C can be one of the most difficult decisions a parent can ever make. The timing is the most important decision. The best advice is never to lie to a child. We have an excellent fact sheet that can provide plenty of advice to parents. http://hcvadvocate.org/hepatitis/factsheets_pdf/TellChild_HCV.pdf
Treatment
As stated above most children have a slowly progressive disease. For the small percentage that have severe fibrosis or cirrhosis, immediate treatment may be needed. The decision to treat or not is never easy and in children it is even more difficult. Some questions that are important to consider include:
Current treatment of pegylated interferon plus ribavirin is approved for children who are three years and older with compensated cirrhosis.
Again, most children have slowly progressive disease, and it takes decades before serious liver disease develops. By this time, children will age to adults and be eligible for interferon- and ribavirin-free therapies that approach 100% effectiveness.
The Future
Hepatitis C infections are on the rise. The so-called Second Epidemic of hepatitis C is affecting females equally as males. As a result, there will be many women of child-bearing age that will become pregnant and have children who may also have hepatitis C.
For the first time, there is an opportunity to prevent mother-to-child transmission. Direct-acting antiviral medications without ribavirin that are pregnancy category B.
Pregnancy Category B: In humans, there are no well-controlled studies. However, in animal studies, pregnant animals received the medicine, and the babies did not show any problems related to the medicine.
However, there have not been any clinical studies using the interferon- and ribavirin-free medications in pregnant women. As a result, studies are needed to evaluate the safety and effectiveness of these new drugs for the mother and the infant.
1American Liver Foundation
Source: Hepatitis C in Children in Times of Changes, Robert D. Baker and Susan S. Baker Walters Kluwer Health, Inc.
It is estimated that Hepatitis C (HCV) occurs in about 0.15% of 6-11 year-olds and 0.4% of 12-19 year-olds. It is estimated that there are 23,000 to 46,000 children in the US with HCV.1 The actual number of children with HCV is unknown because children are not routinely tested for it.
Prior to 1992, the most common transmission route for HCV in children was through blood transfusion, blood products, and organ transplantation. Now that blood products and organs are screened for hepatitis C the most frequent transmission of hepatitis C in infants is mother-to-child transmission. The second most common transmission route in children and teenagers is in those who share equipment to inject drugs (needles, cookers, cotton, water, etc.)
Transmission of HCV from an HCV-infected mother-to-infant occurs about 6% of the time. It can occur up to 10% of the time if a mother is coinfected with HIV and hepatitis C. Also, a high viral load increases the risk of mother-to-infant transmission. Unfortunately, there are no effective strategies or drugs to prevent the transmission of HCV from mother to child.
When a baby is born to an HCV-infected mother, the child will acquire the mother’s HCV antibodies. For this reason, the child will not be tested for HCV antibodies for 18 months. This is the period that it takes for the baby’s body to clear out the mother’s antibodies.
An HCV RNA or viral load test can be given as early as one month. It might be too early since the HCV RNA, or viral load fluctuates during the acute infection phase. Also, babies have a high rate of natural clearance. Most medical providers prefer to wait out the 18-month period to test for HCV antibodies and the confirmatory HCV RNA (viral load test).
Table 1. Children for whom screening is recommended.
- Children and adolescents with unexplained elevated aminotransferasesChildren at risk for vertically acquired HCV
- Children from regions with high prevalence of HCV (adoptees, refugees, immigrants)
- Children and adolescents with HIV
- Children or adolescents who are victims of sexual assault
- Adolescents with multiple sexual partners
- Adolescents who are or were intravenous drug users, even if only once in the past
- Children or adolescents who have ever been on dialysis
- Sexual partner of HCV-infected person
- Children or adolescent who have received needle stick (needles, piercing or tattooing)*
Diagnosis and management of hepatitis C infection in infants, children, and adolescents Pediatric Gastroenterol, Nutr 2012;54:838-855
Baker R. Viral Hepatitis. In: Pohl JF, editor. Pediatric Gastroenterology. Baton Rougue, FL: CRC Press: 2014. pp 313-327
*I read this recommendation with interest because we know that receiving a tattoo or piercing in a commercial parlor is safe. .
Chronic Infection
Approximately 75% of infants who are acutely infected with hepatitis C will continue to chronic infection. In children, the rate of disease progression is slow. There is, however, a small percentage (estimated at less than 2%) of children in whom there is a rapid rate of disease progression that could lead to fibrosis and cirrhosis.
Watch, Wait and Protect
A baby born to an HCV-infected mother should receive the hepatitis A and hepatitis B vaccines to protect the child from becoming infected with another liver disease. As well the baby and child should receive other immunizations to protect the health of the child.
Hepatitis C is not spread by casual contact and infected children should not be restricted from attending daycare or school. Children should be taught that they should not share toothbrushes, nail clippers, razors or any other items that have the potential to transmit hepatitis C.
Any drug, herb or supplement that the child is given should be screened to make sure that it is liver safe. When the child is older, a discussion should take place about sex, drugs, and alcohol.
Most importantly, a child should be medically monitored on a regular basis.
When to Tell a Child
Telling a child that they have hepatitis C can be one of the most difficult decisions a parent can ever make. The timing is the most important decision. The best advice is never to lie to a child. We have an excellent fact sheet that can provide plenty of advice to parents. http://hcvadvocate.org/hepatitis/factsheets_pdf/TellChild_HCV.pdf
Treatment
As stated above most children have a slowly progressive disease. For the small percentage that have severe fibrosis or cirrhosis, immediate treatment may be needed. The decision to treat or not is never easy and in children it is even more difficult. Some questions that are important to consider include:
- Can treatment be postponed until the interferon-free therapies are available?
- Is there an interferon-free clinical trial that your child can enroll in?
- Are you and your child ready to take on interferon treatment and the side effects?
- The new medications are very expensive—there is always the possibility that your insurance company may not cover the new medications.
Current treatment of pegylated interferon plus ribavirin is approved for children who are three years and older with compensated cirrhosis.
Again, most children have slowly progressive disease, and it takes decades before serious liver disease develops. By this time, children will age to adults and be eligible for interferon- and ribavirin-free therapies that approach 100% effectiveness.
The Future
Hepatitis C infections are on the rise. The so-called Second Epidemic of hepatitis C is affecting females equally as males. As a result, there will be many women of child-bearing age that will become pregnant and have children who may also have hepatitis C.
For the first time, there is an opportunity to prevent mother-to-child transmission. Direct-acting antiviral medications without ribavirin that are pregnancy category B.
Pregnancy Category B: In humans, there are no well-controlled studies. However, in animal studies, pregnant animals received the medicine, and the babies did not show any problems related to the medicine.
However, there have not been any clinical studies using the interferon- and ribavirin-free medications in pregnant women. As a result, studies are needed to evaluate the safety and effectiveness of these new drugs for the mother and the infant.
1American Liver Foundation
Source: Hepatitis C in Children in Times of Changes, Robert D. Baker and Susan S. Baker Walters Kluwer Health, Inc.
Subscribe to:
Posts (Atom)