Welcome to HCV Advocate’s hepatitis blog. The intent of this blog is to keep our website audience up-to-date on information about hepatitis and to answer some of our web site and training audience questions. People are encouraged to submit questions and post comments.

For more information on how to use this blog
click here, the HCV drug pipeline click here, and for more information on HCV clinical trials click here

Be sure to check out our other blogs: The HBV Advocate Blog and Hepatitis & Tattoos.

Alan Franciscus
HCV Advocate
HBV Advocate

Drugs in Development / Clinical Trials—Updated October 13, 2014

Saturday, October 25, 2014

Pakistan: Right to health care: PHC urged to announce verdict in substandard drug case

PESHAWAR: The provincial health department has appealed to the Peshawar High Court (PHC) to announce a final decision in the case of the purchase of substandard interferon injections so the medicine can be made available for hepatitis patients.

Around 4,000 patients of hepatitis B and C who cannot afford private treatment have been suffering for over six months due to the non-availability of interferon at public health centres in Khyber-Pakhtunkhwa.

The supply of the therapeutic drug has been suspended because a case is being heard in the PHC regarding the health department’s purchase and supply of low-quality interferon. Interferon vials worth Rs130 million had been purchased by the health department from a Lahore-based company in 2012 and supplied to all public healthcare centres. However, when the drug was tested at a private laboratory in Peshawar it was found to be below par.


Friday, October 24, 2014

New HCSP Fact Sheet on Treatment Pregnancy Categories, by Alan Franciscus

Which drugs are safe to take for a woman while she is pregnant?  If a woman becomes pregnant while on therapy is there a risk to the fetus?  If a woman is pregnant, which drugs increase the risk of birth defects?  To help guide medical providers and patients, the Food and Drug Administration (FDA) has established certain categories that for the most part define what is safe and what is not safe.  But there are gray areas within most of the categories.  This is why it is so important to seek medical advice—medical providers base decisions on a variety of factors, such as does the risk outweigh the benefit, personal experience using a certain drug and the latest medical research.

New HCSP Fact Sheet on HCV Subtype Now Available

There are 185 million people worldwide (2.8%) infected with the hepatitis C virus.  The virus has seven different strains called genotypes—numbered 1 through 7.  The variance (nucleotides) between each genotype is approximately 30-35%.  There are also variances (nucleotides) of about 15% difference between each genotype—these are called subtypes, further classified by alphabetic letters, i.e., genotype 1a, 1b.  The test to find out the genotype and subtype is a blood test. 

Subtype information is necessary in regards to HCV antiviral treatment.  Some medications work better with some of the HCV inhibitors than with others.  This is one of the reasons that multiple HCV inhibitors (protease inhibitors, NS5A inhibitors, polymerase inhibitors) are being combined to treat hepatitis C.

Gilead’s Hepatitis C treatment license misses the mark, despite some increased competition.

WASHINGTON, DC, October 24th, 2014: In September, Gilead Sciences announced licensing agreements for sofosbuvir (Sovaldi) and ledipasvir, two key hepatitis C drugs. Known as direct-acting antivirals (DAAs), these drugs are included in international and national treatment guidelines because they offer significant improvements over previous therapies.

Universities Allied for Essential Medicines (UAEM) expresses concern over these agreements, as these licensing agreements ignore the key middle-income countries that typically experience high burdens of hepatitis C. Approximately 185 million people worldwide are living with with hepatitis C and over 350,000 die annually due to the disease. These deaths could be prevented if access to this life-saving medicine is increased.

UAEM is an international, student-driven non-profit organization dedicated to improving access to medicines worldwide through a combination of university licensing practices, revolutionary research and development practices, and empowering the voices of a new generation of health and science professionals.

The voluntary licensing agreement will allow seven Indian pharmaceutical companies to produce and sell generic versions of sofosbuvir (Sovaldi) and ledipasvir. Sovaldi is currently marketed at US $84,000 for a 12-week treatment course, out of reach for the vast majority in low and middle income countries, even though it could cost only US $68 and $136 to produce in generic form. Gilead’s combination with ledipasivir (Harvoni) is set to sell for an even higher US $94,000 per 12-week treatment. Increasing competition through generic production can effectively reduce prices, increasing  access to life-saving medicines for all.

While Gilead’s license is a step toward better access to hepatitis C medicines, they still allow high prices to remain a barrier to a large portion of those with hepatitis C. The licenses exclude 51 middle income countries that account for 49 million people living with hepatitis C (or 1/4 of the global burden). These potentially profitable emerging markets are denied access to affordable generic versions of sofosbuvir. UAEM is strongly concerned by the fact that Gilead’s licenses exclude 49 million of the most vulnerable patients from access to these lifesaving medicines.

(Hep C press release PDF copy)

Press Release Source:  http://uaem.org/gileads-hepatitis-c-treatment-license-misses-the-mark-despite-some-increased-competition/

Japan: 3 die after being administered hepatitis C drug

The health ministry said Friday three people have died after taking the hepatitis C drug Sovriad, and it has ordered the distributor to revise the drug packaging to say usage should stop when indicated by a patient blood test.

The ministry also ordered the maker and distributor, Janssen Pharmaceutical K.K., to notify doctors and hospitals in writing of the change.

The package insert already warns of possible deterioration of liver function from use of the drug, known generically as Simeprevir Sodium. The ministry directed the packaging also say usage should be discontinued if a blood test indicates certain abnormalities.

Opioid Addiction Crisis Fuels Another: Hep C

Addiction usually leaves a wake of chaos, and all kinds of casualties - marriages, jobs, health. Most tragically, the current crisis of opioid addiction (to prescription painkillers and heroin) in Rhode Island has cost too many lives. Well over 160 Rhode Islanders have died from accidental opioid overdoses so far this year. Hundreds more might have joined them had it not been for the rescue drug naloxone.

Unforeseen consequence
But here's another unforeseen consequence of this epidemic of opioid addiction: hepatitis C. There's been a surge in new users of injection drugs, mainly heroin. Along with it, the CDC reports a surge of new cases of hepatitis C. I spoke with the head of the CDC's division of viral hepatitis, Dr. John Ward, who told me that epidemiologists are still trying to get a handle on this surge. But he called it a new epidemic.


Updated Introductory Statement of When and In Whom to Initiate Therapy

The introductory statement of When and In Whom to Initiate Therapy has been revised to reiterate that treatment will benefit almost all patients in all stages of chronic infection and that urgent initiation of therapy is needed in patients with certain conditions.