April 9, 2012

$1.1 M for hepatitis C screenings and treatment


April 09, 2012

Former Assemblyman Kenneth Zebrowski was sent by doctors to the orthopedist in 2006 for a nagging pain in his side.

Only a few months later, while still in office, Zebrowski died at the age of 61 from liver failure and cirrhosis, caused by hepatitis C.

He contracted the disease from a 1973 blood transfusion, according to his son, Assemblyman Kenneth P. Zebrowski, D-New City, who immediately succeeded his father in representing the 94th Assembly District.

Hepatitis C is a contagious liver disease that causes fibrosis of liver cells and is spread through blood contact.

Despite being diagnosed in 1996 with hepatitis C, the elder Zebrowski didn't start to exhibit symptoms, similar to the flu, until 10 years later.

Up until his last few living months, "at no time, no one told him what to do, not even recommending any types of treatment," said Zebrowski, who added that, by the time doctors matched the symptoms to the prior diagnosis, "it was already too late for my father."

Since his father's death, Zebrowski has not only followed in his father's footsteps in the Legislature, but has dedicated himself to hepatitis C awareness and advocacy, a disease that affects 300,000 New Yorkers, according to Dr. Brian Edlin, an epidemiologist at the Center for the Study of Hepatitis C.

A small victory for Zebrowski and other activist groups, including Status C Unknown, a nonprofit organization that provides hepatitis C support and education, is the inclusion of a $1.1 million line item in the Medicaid Redesign portion of the 2012-2013 budget for hepatitis C screening and treatment.

Despite this funding specifically being dedicated to hepatitis C treatment and screening, it is in the budget as part of a larger $104.5 million appropriated for the AIDS Institute, according to Morris Peters of the Division of Budget.

The AIDS Institute may ultimately designate even more money for the benefit of hepatitis C, said Peters, pointing out many programs they run would benefit both hepatitis C and HIV/AIDS patients.

The Medicaid Redesign Team suggested including $2.1 million in the budget towards hepatitis C care, coordination and service integration by adding hepatitis services to already established clinics, primary care practices and substance abuse settings, with $1.5 million coming from the state budget and the rest being federally funded.

"I think it's great that it made it in the final budget. I was happy that the governor originally put it in … and at the end of the day, all three sides recognized that it was money well spent," said Zebrowski, pointing to "exciting new treatments" as reason for funding necessity.

"We know the budgets are tight, but hepatitis C is taking a personal and financial toll on our state," said Shari Foster, founder of Status C Unknown, who praised the inclusion.

Chairman of the Assembly Health Committee and member of the Medicaid Redesign Team Richard Gottfried, D-Manhattan, said including hepatitis C care in the Medicaid program is "enormously important."

Foster said this year's funding will allow the state to adopt a plan to "combat the increasing incidence" of hepatitis C in New York state with education, testing and treatment programs.

The Centers for Disease Control and Prevention estimates hepatitis C accounts for 8,000 to 10,000 deaths each year in the United States, with Edlin placing the number at 15,000, more than the number of deaths attributed to HIV.

"The numbers crossed in 2007," said Edlin.

According to Edlin, the beginning stages of the virus, known as acute hepatitis C, can be fought off by the immune system. Centers for Disease Control and Prevention said approximately 15 to 25 percent of people who contract hepatitis C recover from the virus without treatment. If the infection is not cleared from the body, it will develop into chronic hepatitis C that will last for years.

New "extremely effective and exciting" treatment for hepatitis C is available, said Edlin and is mostly successful when given during the acute phase of the virus. But it is rarely detected in the acute phase because there are no symptoms. Usually, said Edlin, infected persons don't see symptoms of the virus until 20 to 30 years later.

"It is unconscionable that thousands of New York state residents are sick and dying every year because they don't know they have hepatitis C, when it can be identified by a simple blood test and treated," said Foster, who almost died from internal bleeding when she went into liver failure because she didn't know she had hepatitis C.

Hepatitis C is most prevalent among the baby boomer generation, said Edlin, because before 1992, blood wasn't tested for the disease. In fact, it didn't even have a name according to Shari, who said it was called "Not Hep A, Not Hep B."

Hepatitis C deaths "will only continue to get worse because baby boomers are reaching the point where they have been infected for 20 years," said Edlin.

The Centers for Disease Control and Prevention suggest those who have a had a blood transfusion or organ transplant before 1992, recipients of clotting factor concentrates before 1987, former and current injection drug users, person with HIV and children born to hepatitis C positive mothers should be screened for the virus.


More On EASL Abstracts On Oral Combination Regimens

April 9, 2012


Key Takeaway

CORRECTION: We are correcting our note for the response rates in G1 patients  combining both Arms A and B. EASL abstract data disclosed an encouraging  97% 12-week response and safety profile for the two-drug 7977+daclatasvir  (NS5a) regimen in genotype 1 treatment-naives. We remain optimistic on 7977 although valuation keeps us on the sidelines.

Positive 12-Week Data For Two-Drug Oral Regimen Of 7977+Daclatasvir
Without Ribavirin
. The Street is closely watching data for the highly anticipated Phase 2 study of GILD’s 7977 (nucleoside NS5B inhibitor) and Bristol’s (BMY, $33.68, Buy) daclatasvir (NS5a, DCV). In the first part of this open-label study, 44 genotype 1 (G1, of which 73% were 1a) and 44 genotype 2/3 (G2/3) treatment-naïve patients were randomized to either 7977 for 7 days then DCV + GS-7977 for 23 weeks (n=31, 15 G1), DCV +7977 for 24 weeks (n=28, 14 G1), or DCV +GS-7977 + ribavirin (rbv) for 24 weeks (n=29, 15 G1). DCV+7977 showed undetectable rapid virological responses (RVR) of 90% in G1 and 83% in G2/3. Overall, DCV+7977 and DCV+7977+rbv showed 93% undetectable responses after 12 weeks of treatment. For the two-drug regimen, 12-week response rates were 97% in G1 (28/29) and 90% in G2/3 (27/30). Virologic breakthrough occurred in one GT3 patient. For the three-drug regimen, the response rates were 100% in G1 (15/15) and 86% in G2/3 (12/14). The most frequent AEs were fatigue, headache, and nausea. Grade 3-4 laboratory abnormalities included elevated cholesterol (n=1), elevated glucose (2), low hemoglobin (6), lymphopenia (1), and low phosphorus (2). Two patients discontinued therapy for nondrug related AEs (fibromyalgia, CVA).

Our Take: 7977+Daclatasvir 12-Week Data Promising But Focus Remains SVR4 Data. As a reminder, key data in April at the EASL meeting will be the 4-week sustained virologic response (SVR4) data for GS7977 in G1 treatment-naïve patients in the ELECTRON study, further data from the Phase 2 study of DCV+7977, and early data for GILD’s own NS5a inhibitor 5885+7977. While the key efficacy endpoint to watch remains the post-treatment SVR rates, we are encouraged that a two-drug oral regimen of GILD’s 7977+ BMY’s DCV showed high 12-week responses in treatment-naives. Given the high relapse rate previously observed with 7977-rbv in G1 null responders, it remains to be seen whether the 7977+NS5a regimen can achieve attractive SVR rates in G1 patients, particularly in G1a patients.

SVR Of ~65% Seen For GILD’s 4-drug Oral Regimen In Genotype-1 (G1) Treatment Naives— Focus Remains On 7977 Combination Data. EASL abstract data were released for the higher GS5885 dose “arm 2” (90mg, n=94) of GILD’s 4 drug HCV regimen in 12-week treatment of G1-naives: GS-5885 (NS5a)+30mg bid tegobuvir (non-nucleoside NS5b)+200mg daily GS-9451 (protease inhibitor)+1000-1200mg daily ribavirin (rbv). The results for the 4-drug oral regimen showed 2-week virologic response of 79% (74/94). 64 of Arm 2 patients remained viral undetectable through the end of 12- week treatment with 11% virological breakthroughs (8/74) in post-RVR treatment. Of these 64 patients, 33 were randomized to post-treatment assessment of 4-week sustained virological responses (SVR4) and 31 were randomized to 24-week SVR (SVR24) assessment. 27 patients have reached 4-week post-treatment mark and 96% (26/27) achieved SVR4, of which 18/19 were genotype G1a and 8/8 were G1b. On safety, the most common reported AEs for the GILD quad regimen were headache (21%), fatigue (16%), diarrhea (14%), nausea (13%), and rash (11%) and there were no deaths, decreases in blood counts, or serious AE’s noted. Two patients withdrew from the study in the post-RVR treatment period but there were no discontinuations due to drug related AEs. Overall, on-treatment response rates were not as high as we had hoped for, calling into question the activity of the PI and the NS5a. As a reminder, a triple combination of Abbott’s (ABT, Buy, $61.30) PI and non-nuc yielded much higher SVR rates in G1 naïve patients. No concerning safety issues arose, which is promising as this represents the longest dosing data for 5885, the NS5a that is being tested in the critical regimen with 7977, which the Street is looking to provide even higher SVR rates in G1 patients.

Data For Mericitabine+ Ritonavir-Boosted Danoprevir Regimen Opens Opportunity For Other Regimens. As a reminder, Roche (ROG VX, Buy, CHF157.50)initiated the Phase 2b INFORM-SVR trial in 1Q11, studying mericitabine (MCB, 1000mg BID) + ritonavir-boosted danoprevir (DNVr, 100mg/100mg BID) +/- Peg-IFN/ribaviri(RBV, 1000/1200mg daily) for 12/24 weeks in treatment-naïve, non-cirrhotic, G1 patients. At week 4, 91% of patients on MCB+DNVr+RBV and 93% of MCB+DNVr+placebo had HCV RNA ≤ 15IU/mL. The 8-week SVR (SVR8) in MCB+DNVr+RBV for 24 weeks of treatment was 41% overall (26/63), with 71% (15/21) in G1b and 26% (11/42) in G1a patients. Randomization to the 12 week arm was stopped early due to unacceptable relapse rates. Furthermore, MCB+DNVr +/- RBV was noted to be safe and well tolerated with only four SAEs and two discontinuations due to AEs were observed across arms, although the nature of the SAEs were not disclosed. While the SVR rate was promising for this interferon-free regimen in G1b, the necessity for a 24-week regimen and relatively low SVR for G1a would leave open the opportunity for other regimens.

Inconvenient Dosing Schedule And Rash Issues With BI201335+BI207127 For Compensated Cirrhosis, But 335 Remains An Attractive Asset. In the interim analysis of its SOUND-C2 open-label Phase 2b study evaluating interferon-free regimens of protease inhibitor BI201335 (335) + non-nucleoside inhibitor BI207127 (127), given either three times daily (TID) or twice daily (BID),+/- ribavirin (rbv) for up to 40 weeks, 12- week SVR (SVR12) of up to 60% SVR12 in G1a and up to 83% in G1b was observed in treatment-naïve patients with compensated liver cirrhosis. Specifically, SVR12 rates of 60% was seen in G1a patients (3/5) and 56% of G1b patients (9/16) on 335+127 TID+rbv for up to 40 weeks, while 29% (2/7) of G1a and 83% (5/6) of G1b was observed for 28 weeks of 335+127 BID+rbv. On safety, mild skin and gastrointestinal were noted to be the most common, and we note that all five patients in the G1a pooled arm treated with 127 TID up to 40 weeks discontinued drug because of a rash, and two of those patients had also developed photosensitivity. We believe that the length of dosing, more than once daily dosing of 127, and rash-related discontinuations will likely prevent this regimen from becoming attractive, but the study serves as another proof of concept for a triple regimen in G1 patients and 335 remains an interesting asset for a more potent combination.

Continue Reading for more reports from Thomas Wei, Equity Analyst  (stock analysis)…

Also See: EASL 2012: Bristol-Gilead Hep C Drug Data Leaks

Hepatitis C: The deadly drill


The use of unsterilised dental instrument is the second largest cause of the spread of hepatitis in Pakistan.

By Ali Usman

Published: April 9, 2012

LAHORE: Imran Ali got the shock of his life when his blood samples tested positive for Hepatitis C. He had gone to a private clinic to donate blood to one of his friends, but instead found out that has own blood was tainted with the deadly virus. What was even more mystifying was the fact that he had tested negative for Hepatitis C when he had donated blood four months ago. It was easy for the health-conscious 22-year-old to put two and two together.

“The only thing that I could figure out which could have caused hepatitis was a dental examination I underwent,” pinpoints Ali.

“I had gone to a small clinic near my home in Iqbal Town and I was told the equipment was clinically sterilised but later I found out that using an autoclave [a steam-heated vessel where dental instruments are kept and boiled at certain heat and pressure levels to kill all viruses] is the proper way to get sterilisation done and the clinic didn’t have that procedure.”

Ali subsequently filed an application with the Health Department to take action against the private clinic, but his plea did not bear any fruit. His friends and lawyers then advised him to file a complaint with the Ombudsman’s office or file a case against the clinic in court.

“But I didn’t have any proof to substantiate my case so I didn’t consider it a viable option. Had the Health Department taken the matter seriously and seized the equipment of the clinic, it could easily have established that the equipment wasn’t sterilized properly,” he says in dismay.

Unfortunately Ali’s case is not an isolated one. According to the statistics available with the Hepatitis Prevention and Control Programme (HPCP), which gives guidelines and drafts policy for controlling hepatitis, every ninth person in Pakistan is a hepatitis patient. There are no proper figures available, but health officials say that the second largest transmission source for hepatitis in Pakistan is non-sterilised dental equipment. The number one cause is reused blades and razors at barber shops.

What puts those undergoing dental work particularly at risk is that in many dental procedures, blood will necessarily contaminate instruments. “In orthodontics (the alignment of teeth), maxillofacial surgery or root-canal treatments, instruments will definitely come in contact with blood,” explains dental surgeon Dr Anwar. “There is a small pin called the reamer which is inserted into the gums and, in many cases, it isn’t sterilised properly if it’s not put in autoclaves.”

Thus, the proper sterilisation of dental equipment is of utmost importance for preventing the spread of blood-related infection. Yet, this basic safety precaution is neglected at several dental clinics.

“There are above 30,000 unregistered so-called dental surgeons and quacks in Punjab alone, and they are the second largest source of spreading hepatitis in country,” says Pakistan Medical Association (PMA) Joint Secretary Dr Salman Kazmi. “Other than some teaching public hospitals there isn’t any Central Sterilisation Services Department (CSSD) where all surgical instruments, especially dental instruments could be properly sterilised.”

One of the reasons that autoclaves, while being of utmost importance, are severely underused, is simply because of the cost. A good autoclave costs around Rs 250,000 and runs on gas or electricity. This means that even those small clinics that actually consider sterilisation important may not be able to afford an autoclave.

In the absence of proper equipment, they use other methods which are not as effective.

“What happens here that in many small clinics dental surgeons use ovens to sterilise the instrument which isn’t at all effective in killing bacteria. Only an autoclave can do it properly and safely,” says Abid.

And even where autoclaves are available, there’s the usual problem of poor maintenance and apathy.

“There are autoclaves in all government hospitals at district headquarters, however in several cases they are not working properly,” reveals Kazmi.

Another way to disinfect instruments is by chemical sterilisation which is conducted by dipping instruments in a solution which has chemicals like gludraldehyde.

While Dr Anwar and Dr Kazmi lay the blame on the quacks, others allege that even reputed hospitals don’t have proper means of cleaning dental gear. “There are some departments at the Punjab Dental Hospital, where there isn’t any proper mechanism of sterilisation. In the scaling department, there isn’t any proper procedure for sterilization and even autoclaves are out of order,” claims a dental surgeon at the PDH. “The surgery department system is very nice, but inside every department, instruments and mouth mirrors are dipped in the same solution for the whole day for sterilisation. The same instruments go in every patient’s mouth and are likely to spread hepatitis from one person to the other.” Given that over 550 patients frequent the PDH every day, the chances for transmission are thus extremely high.

However, the Medical Superintendent (MS) of the Punjab Dental Hospital refuted the claims that dental equipment is not properly disinfected at public hospitals. “We properly steriliseequipment at public hospitals, however the problem lies with quacks and some small clinics,” she says.

A dentist surgeon at Mayo Hospital, however, claims that it’s not as simple as that. “Most of the time the sterilization of dental equipment in public hospitals depends on lower level employees, who do it during the evening or night. If they don’t do their job honestly the risk factor goes above manifold,” he explains. “There should be some training sessions to create awareness and responsibility among lower staffers who sterilisedental equipment in order to prevent hepatitis from spreading.”

However, any oversights or ommissions in this regard often go unpunished. Dr Altaf Hussain, the head of health department’s Hepatitis Preventive Control Programme (HPCP) says, “We give a policy line to control hepatitis, but we don’t have any mechanism to check or punish those who use non-sterilized instruments. The EDOs (Health) in their districts are responsible for this.”

The Punjab Government had in fact launched an anti-quackery campaign to prevent the spread of hepatitis, but it failed to show results. An official in the health department claims the problem persists because government officials have no proper mechanism to inspect instruments at private clinics and drug inspectors are only sent out to check on these clinics once in a blue moon.

According to Dr Altaf Hussain, applications regarding unsterilised instruments can be filed with the area’s EDO Health, after which the health department has to take appropriate action.

Sadly, this procedure is not really followed. “The drug inspectors mostly settle issue with quacks or small clinics on their own and the show goes on and these people keep playing with lives of innocent people,” reveals another official.

In this situation, victims like Imran really have nowhere to turn to have their complaints heard. And every day that this situation persists, more and more people fall victim to this criminal neglect.

Published in The Express Tribune, March 21st, 2012.