Special note: December's group will meet on the 3rd then returns to usual group time    

 

 

 

Too many people believe that HIV is no longer a serious threat to their lives or health. In 2006, there were an estimated 56,300 national new HIV infections, a 40% increase over the annual estimates used for a decade. The new Center's for Disease Control and Prevention (CDC) data did not indicate a jump in new infections, it simply showed that the epidemic is, and has been, much worse than we thought.
 
This is why World AIDS Day is so important! It allows us to focus community attention on the continuing and devastating effects of the epidemic in this country. Despite advances in treatment and outreach, too many people still don't know their HIV status, enter care late in the progression of their HIV disease, or are deeply affected by the stigma associated with the virus.

Hepatocellular Carcinoma News from the New England Journal of Medicine. 
 
The New England Journal of Medicine published results from the SHARP Phase 3 trial demonstrating that Nexavar decreased the absolute risk of death by 31 percent in patients with unresectable hepatocellular carcinoma (HCC) versus patients who received placebo.  This represents a 44 percent improvement in median overall survival for patients treated with Nexavar. 
 
The international Phase 3 double-blind, placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) trial evaluated 602 liver cancer patients who had no prior systemic therapy.  The primary endpoints of the study included overall survival and time to symptomatic progression in patients administered Nexavar versus those who received placebo. Secondary endpoints included time to progression, disease control rate and safety. 
 
These data were published in the July 24, 2008 issue of The New England Journal of Medicine. To download a copy of the NEJM article, please visit http://articleworks.cadmus.com/doc/881029   
  
Nexavar Approved in China and Italy -  
 
Nexavar received approval for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) in China and Italy. 
 
The approvals were based on two international Phase 3 double-blind, placebo-controlled trials that evaluated more than 800 patients who received no prior systemic therapy.  
 
Liver cancer is the sixth most common cancer worldwide and the third leading cause of cancer-related deaths globally. The incidence of liver cancer in China is over 350,000 and every year more than 320,000 people die from liver cancer.[1] 
 
 
Clinical Trial News - 
  
STORM (Sorafenib as Adjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma) Trial 
 
Patient enrollment has started for the STORM Sorafenib as Adjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma trial.  The randomized, double-blind, placebo-controlled Phase 3 study is evaluating Nexavar® (sorafenib) tablets as adjuvant treatment for patients with hepatocellular carcinoma (HCC). 
 
The international multicenter study is expected to enroll approximately 1,100 patients and will include patients who have received surgical resection or local ablation.  The primary endpoint of the study is recurrence-free survival.  Secondary endpoints include overall survival, time to recurrence, patient-reported outcomes, plasma biomarkers, safety and tolerability.  The study will be conducted at more than 200 sites in North America, South America, Europe and the Asia-Pacific region, including Japan.  
 
In addition, the U.S. Food and Drug Administration (FDA) has completed a
Special Protocol Assessment (SPA) for the STORM trial.   An SPA is a
written agreement on the design and size of a clinical trial intended to form the basis for a new drug application. 
 
For information about enrolling in the study, please visit:
http://www.clinicaltrials.gov/ct2/show/NCT00692770?term=STORM+trial&rank

 

To read more articles about this or other related newsworthy pieces visit www.hivandhepatitis.com. 

Interferon and Anti-depressants
A Personal Story - John 
 
"I was diagnosed with hepatitis C (Stage 3 fibrosis) in 1993, and I was told that I was five years away from a liver transplant (or the alternative).  Eager to avoid this unpleasant prospect, I underwent Interferon monotherapy for six months in 1995.   It was unsuccessful and although I managed to get through the whole process, I felt terrible by the end.  Upon stopping, I didn't recover but instead saw my health continue to deteriorate.  Within nine months I had to give up my job and file for disability.  My doctor said the problem wasn't from the interferon but from the hepatitis.  I had my doubts.
 
 In 1997 I participated in a trial involving Ribavirin and Interferon. I responded beautifully (my enzymes quickly dropped to normal and the virus was undetectable after 12 weeks).  But given my weakened condition at the beginning of treatment I became extremely ill and bedridden (weak, severe non-stop flu-like symptoms, barely able to stand, and unable to even listen to the radio). I have no doubt the interferon would have eventually killed me. I stopped treatment after four months and the virus relapsed immediately.  It took about three months to recover to my pre-treatment condition.
 
Frustrated by my strong response but poor tolerance, my gastroenterologist the next year suggested an attenuated (diluted) dosage regimen of Interferon and Ribavirin.  I trustingly, but foolishly, agreed. Again, I quickly became extremely ill and stopped after only two months.  This time, I did not recover and spent the next two years unable to even walk around the block.  I thought the Interferon had permanently ruined me.  By the grace of God (not my gastroenterologist) I was finally directed to a progressive psychiatrist who put me on high doses of the anti-depressant Remeron.  I had been on another anti-depressant and did not feel emotionally depressed.  Within three days I noticed my energy slowly returning, and over the next six months, I gradually recovered to my strongest level in five years.
 
While many people tolerate interferon reasonably well, and it does cure a good percentage of those who are able to endure it, it is also heavy-duty chemotherapy that can severely and permanently damage brain chemistry in a few unlucky souls. Doctors don't have to experience this barbaric treatment themselves and the aggressive ones will encourage you to stay on regardless of how hellish you feel.  Put as much trust in your own common sense as you do in your doctor. 
 
Chronic hepatitis C keeps the immune system in a constant up-regulated mode, which, over the long term, upsets brain chemistry and can cause depression and its companion, fatigue.  The medical profession is only recently coming to terms with the fact that much hepatitis-related fatigue is due to depression and not liver impairment.  Additionally, it is well known that Interferon can cause depression and major fatigue, which in some cases is not alleviated when treatment ends.  Most gastroenterologists don't know enough about psychiatric effects of hepatitis C and interferon to effectively treat them.  It is my strong opinion that anyone who has hepatitis C, or is undergoing interferon therapy, should be under the care of a psychiatrist.  It made all the difference for me."