sarcoma: Decline reported in AIDS-related skin cancer
ATLANTA, Georgia (Reuters) -- The number of HIV patients with Kaposi sarcoma, a once-rare cancer that became a marker for AIDS in the early days of the epidemic, has declined sharply due to the use of antiretroviral drugs, according to a European study released Monday.
The annual incidence of the cancer fell 39 percent between 1994 and 2003, according to a study of nearly 10,000 people with HIV by the Royal Free and University College in London and a handful of other European hospitals and health centers.
Kaposi sarcoma first appears as a brownish-colored skin lesion, although it can also develop in the lungs, liver and other internal organs. Until AIDS surfaced in 1981, the cancer was seen primarily in elderly Mediterranean men.
It became one of the most common ailments plaguing AIDS patients in the 1980s.
But the introduction a decade later of highly active antiretroviral therapy (HAART) -- a treatment based on a combination of drugs -- gave doctors a powerful new weapon against the opportunistic diseases that killed many AIDS victims.
Anecdotal data and small studies had indicated Kaposi sarcoma cases were declining as the new drugs suppressed levels of HIV in patients' blood and allowed their immune systems to recover.
The large European study was, however, the first conclusive indication of a link between the therapy and declining cases of Kaposi sarcoma. The findings were published in the May 10 online edition of the American Cancer Society journal Cancer.
In their study, the Europeans noted that those with a higher current CD4 count -- a measure of immune system health -- or who had been on HAART therapy for a longer period of time had a decreased incidence of the cancer.
"This indicates that the current CD4 count remains one of the most important prognostic factors for Kaposi sarcoma, and patients who start HAART should experience a reduction in the risk of Kaposi sarcoma if the CD4 count starts to rise," the researchers said.
The good news was partly overshadowed by a significantly increased incidence of the disease among gay men and in patients from Central and Western Europe. Kaposi sarcoma makes up 6 percent of all AIDS-defining illnesses each year.
AIDS has killed more than 21 million people around the world, including about 500,000 Americans since 1981. About 40,000 Americans become infected with HIV every year.
the fact that ADVR has been holding this so close to the vest - even to
the point of not publicly announcing they had quit after 23 patients
after saying the protocol was designed for 30 - only enlarges the
questions I asked.
I sure hope it's more than feeling better, I assume weight gain and other physical attributes. However, without double-blinding, these results are worthless insofar as FDA submissions go.
the PR of August 13, 2002 announcing the approval of the Israel studies
in AIDS patients:
"Product R appears to act synergistically with the drugs used in HAART regimens to suppress the replication of HIV and increase the CD4 and CD8 counts in patients with AIDS. Thus, Product R may prove to be an important "enabler" drug in the treatment of AIDS".
This being the case, it stands to reason that the patient CD4 and CD8 counts were indeed measured in the Israeli trials. What worries me though is that these were not mentioned at all in the PR from last November that disclosed the results on the first 15 patients. If the results on viral loads, CD4 and CD8 counts had been good or clear-cut, surely these would have been revealed. If the earlier Barbados studies that were published as a journal article are any guide, the drug AVR118 administered alone had only a modest effect on CD4 counts and no significant effects on viral loads.
We were merely told in the November 2003 PR that the drug increased weight in some of the first 15 patients (by how much we weren't told) and that in others it stayed stable and did not decline. We were not told how this weight gain or weight stabilization compares with studies on other anti-cachexia drugs in the medical literature, such as Megace or human growth hormone. We were also told that all patients felt better. I guess this was in response to a mere verbal questioning of the patients or a patient questionaire.
There are many unanswered questions as yet as to the efficacy of the drug, and it will be interesting to see what the ASCO abstract says (if indeed, it deals with the Israel AIDS cachexia study).
do know that "The patients are part of a Phase I/Phase II open-label
dose escalation clinical trial being conducted at The Kaplan Medical
Center in Rehovot, Israel.
The only thing we know about endpoints are that the patients are being monitiored for "improvement in appetite, weight gain or stability, and enhanced quality of life in all the patients."
In the November PR touting the "Positive Preliminary Results", the company used such words & phrases as "no significant side effects", "apparent strong clinical results demonstrated", "AVR118...will merit much broader scientific analysis in a large study of AIDS patients", "very encouraging, data is worthy of a presentation at an appropriate international scientific meeting", "promising preliminary results can be shared with the global scientific community", "potential utility of AVR118 in this group of patients", "I eagerly await possible confirmation of our preliminary results", "These results garnered midway through the clinical trial appear to validate our expectations of the clinical activity of the unique immunomodulator AVR118."
Which all sounds very welll & good. It will be nice to see just what data they used to arrive at these conclusions...
AIDS Poses 'Unique Threat to Human Society'
GENEVA (Reuters) May 11 - The world is not ready for the full social and economic impact of AIDS, which has killed more than 20 million people in the past 25 years, the World Health Organization warned on Tuesday.
The U.N. agency said unless nations pull together to defeat it, AIDS will destroy any hope of a better life for tens of millions, including noninfected individuals, living in poverty around the globe.
The world at large "is far from ready for what is to come," including catastrophic social and economic consequences for many communities and countries if the epidemic continues unchecked, WHO said in its annual report.
"Although it has seemed a familiar enemy for the last 20 years, HIV/AIDS is only now beginning to be seen for what it is: A unique threat to human society whose impact will be felt for generations to come," it said.
It is already undermining the U.N. Millennium goals of eradicating by 2015 extreme poverty and hunger, reducing infant and maternal mortality and the spread of other diseases, and achieving universal primary education, it added.
WHO's annual report on key aspects of international health--this year focusing on AIDS, the leading cause of death among 15-59 year-olds worldwide--is to be presented at the agency's annual assembly next week.
The 170-page report, entitled "Changing History," injected a small note of optimism into the overall gloom emerging from its AIDS statistics-34 to 46 million people infected, with 5 million new infection each year.
A concerted international effort to get the latest treatments to sufferers and promote ways to avoid infection could turn the tide, it said, even though no vaccine is in sight despite years of research.
It cited many cases--in the Caribbean, Latin America, Africa and Asia--where the latest antiretroviral drugs have pulled patients back from the brink of death and restored them as active citizens contributing to their national economies.
But of the six million people in developing countries who need the therapy, only 400,000 got it last year, the report said. More than 90% of HIV-infected individuals live in just 34 countries.
The report said although Africa is home to two thirds of all people living with the disease, it accounts for only 11% of the world's total population of some six billion.
About 1 in 12 African adults is infected.