KAISER DAILY HIV/AIDS REPORT
A service of kaisernetwork.org
http://www.kaisernetwork.org/dailyreports/hiv

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*** WEBCASTS: NATIONAL HIV PREVENTION CONFERENCE ***
View webcasts of sessions from the 2003 National
HIV Prevention Conference in Atlanta, including:
--"Challenges in HIV Prevention"
-- Closing Session
http://www.kaisernetwork.org/cdc2003
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________________________________________



Friday, August 1, 2003

POLITICS AND POLICY
========================================
1. 180 Groups Send Letter to President Bush Calling for $283M in New
Federal Funding for ADAPs


ACROSS THE NATION
========================================
2. Number of HIV/AIDS Cases in Maine Increasing, Mirroring National Trend


PUBLIC HEALTH & EDUCATION
========================================
3. Health Officials Urge Increased HIV Testing, Counseling of Male
Bathhouse Patrons


GLOBAL CHALLENGES
========================================
4. United Nations To Hold One-Day Session Focusing on HIV/AIDS; Annan Urges
WTO Compromise on Drug Access

5. South African Medicines Control Council Calls for Alternate Nevirapine
Efficacy Data in 90 Days, Could Ban Use of Drug


SCIENCE & MEDICINE
========================================
6. GlaxoSmithKline Issues Letter Saying Not To Use Lamivudine, Abacavir,
Tenofovir Combination as First-Line Therapy


OPINION
========================================
7. Kaiser Daily HIV/AIDS Report Summarizes Editorials on New Preliminary
CDC Data Showing Increase in New AIDS Cases

****************************************

POLITICS AND POLICY


1. 180 Groups Send Letter to President Bush Calling for $283M in New
Federal Funding for ADAPs

Access this story and related links online:
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=19132

One hundred and eighty groups from 29 states yesterday sent a letter to
President Bush asking that he request $283 million in new federal funding
for AIDS Drug Assistance Programs in fiscal year 2004, according to an AIDS
Treatment Data Network release. Congress so far has appropriated between
10% and 15% of that amount (ATDN release, 7/31). According to a recent
National ADAP Monitoring Project report, which was released in April and
based on a survey by the Kaiser Family Foundation, the National Alliance
for State and Territorial AIDS Directors and the AIDS Treatment Data
Network, although the national ADAP budget increased by $86 million during
FY 2000, the program is running out of money in an increasing number of
states. ADAPs provide prescription drugs in all 50 states, the District of
Columbia, Puerto Rico and Guam for HIV-positive individuals who are
uninsured and could otherwise not access such drugs. However, at least 10
states, including Georgia, Maine and Texas, have had to restrict access to
antiretroviral drugs or cap program enrollments because of limited funding
(Kaiser Daily HIV/AIDS Report, 6/9). The letter says that the "increase is
needed to keep ADAPs stable through FY 2004," adding that the
administration "must take as public a stand on domestic AIDS needs as it
has on addressing the global AIDS crisis." The letter also calls for Bush
to "support the highest possible funding for all programs funded by the
Ryan White CARE Act to protect critical support and care services for
people with HIV/AIDS." The letter concludes that the administration "must
take bold steps in addressing this urgent need" (Letter text, 7/31). A
list of the signing organizations is available online.

ACROSS THE NATION


2. Number of HIV/AIDS Cases in Maine Increasing, Mirroring National Trend

Access this story and related links online:
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=19133

The number of new HIV/AIDS cases in Maine has increased for the first time
in several years, according to state Bureau of Health statistics released
on Tuesday, the Bangor Daily News reports. Between Jan. 1 and July 24,
2003, 33 new HIV infections were reported in the state, compared with 19
newly reported HIV cases during the same period last year, according to the
data. In addition, the bureau has reported 28 new AIDS diagnoses so far
this year, compared with 21 new cases during the same period last year.
According to the bureau, Maine has 500 reported AIDS cases and 700 reported
HIV cases, more than ever before in the state. Mark Griswold, who compiles
data for the state's HIV/AIDS program, said that the total number of
HIV/AIDS cases in Maine is "tiny," but the increase in new cases is "still
very troubling." The increase in new HIV/AIDS cases in the state reflects a
national trend (Haskell, Bangor Daily News, 7/30). The CDC on Monday
announced at the 2003 National HIV Prevention Conference in Atlanta that
there was a 2.2% overall increase in the number of new U.S. AIDS cases in
2002 and that the number of new HIV diagnoses among men who have sex with
men rose for the third consecutive year in 2002, increasing 7.1% from 2001
to 2002 (Kaiser Daily HIV/AIDS Report, 7/29). Most of Maine's HIV/AIDS
cases are among men who have sex with men and injection drug users,
according to Griswold.

'Prevention Fatigue'


Griswold and Drew Thomits, educational programs supervisor for the Eastern
Maine AIDS Network, said that the increase in HIV/AIDS cases could be
attributed to "prevention fatigue" in older MSM and lack of awareness in
younger MSM who have not had many friends die of AIDS-related causes,
according to the Daily News. "People get tired of hearing 'safe sex' all
the time and never 'We've made great strides and now you don't have to
worry,'" Thomits said, adding, "When we didn't have effective testing and
treatments, people saw wasting and death and all the horrible things that
happen with this disease. Now if they know someone [living with HIV/AIDS],
they may see them healthy, out working -- they don't see how hard it is to
live with AIDS." People are also not getting tested early enough to get
effective treatment, according to the Daily News. Griswold said that
nearly half of the people who tested HIV-positive between 1998 and 2002
were diagnosed with AIDS within six months, indicating that people are not
getting tested until they start having symptoms. Charles Dwyer, manager of
Maine's HIV program, said that the state will be launching an awareness
campaign in the next few weeks, which will include posters in 1,000
doctor's offices and at nightclubs and other highly visible locations
(Bangor Daily News, 7/30).

Increases in Numbers of Other STDs


Griswold added that a similar increase among other sexually transmitted
diseases is often seen in conjunction with a rise in new HIV/AIDS cases,
suggesting overall changes in sexual behavior among the population,
according to the AP/Foster's Daily Democrat. Nine new syphilis cases were
reported in the state in the first half of 2003, compared with only one new
case in the first half of 2002. In addition, 123 new gonorrhea cases were
reported in the first half of 2003, compared with 66 in the first half of
2002, and 1,121 new chlamydia cases were reported in the first half of
2003, compared with 829 over the same period last year (AP/Foster's Daily
Democrat, 7/30).

PUBLIC HEALTH & EDUCATION


3. Health Officials Urge Increased HIV Testing, Counseling of Male
Bathhouse Patrons

Access this story and related links online:
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=19134

Los Angeles County health officials are urging increased HIV testing and
counseling in gay bathhouses, after a study released this week at the 2003
National HIV Prevention Conference in Atlanta showed that male bathhouse
patrons were twice as likely as men tested in public health clinics or
community-based agencies to be HIV-positive, the Los Angeles Times reports.
Officials suggested that HIV prevention education and testing may
discourage risky behavior in the bathhouses. The study, conducted by
researchers from the Los Angeles County Department of Health Services,
found that of the 916 men tested at two Los Angeles bathhouses between May
2001 and December 2002, 11% of them tested HIV-positive, compared with 5.5%
of the men who were tested at public clinics and community-based agencies
(Rodriguez, Los Angeles Times, 8/1). In addition, only 40% of the men who
tested positive for HIV returned to learn their results, while 60% of the
men testing positive failed to return to learn their HIV status (Kaiser
Daily HIV/AIDS Report, 7/30). The fact that the test results took a week
to be available might have played a role in why the men did not return,
according to Trista Bingham, director of the study and an epidemiologist
with the health department. However, that could change with the use of
OraSure's rapid HIV test OraQuick, Bingham added (Los Angeles Times, 8/1).
The test offers results that are 99.6% accurate within 20 minutes (Kaiser
Daily HIV/AIDS Report, 6/24). Lee Klosinski, director of programs for AIDS
Project Los Angeles, said that the 40% follow-up finding is "a sobering
figure, given the potential positive impact that knowing their HIV status
can have for an individual. As helpful as it is to know, if you're
HIV-positive it's still a scary thing to actually find out" (Los Angeles
Times, 8/1).

Webcasts of selected sessions of the conference are available online
through kaisernetwork.org's HealthCast.

GLOBAL CHALLENGES


4. United Nations To Hold One-Day Session Focusing on HIV/AIDS; Annan Urges
WTO Compromise on Drug Access

Access this story and related links online:
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=19135

The United Nations plans to hold a one-day session on Sept. 22 to focus on
HIV/AIDS, tuberculosis and malaria in an effort to increase funding for the
Global Fund to Fight AIDS, Tuberculosis and Malaria, U.N. Secretary-General
Kofi Annan announced on Wednesday at a press conference, the Associated
Press reports. Approximately six million people worldwide die each year
from the three diseases, and about 348 million people are affected by the
diseases, a threat Annan said the United Nations "cannot afford to ignore."
Annan said that Africa has been hardest hit by HIV/AIDS but that the
disease is spreading "very fast" in Asia, Eastern Europe and the Caribbean.
"It is truly a global crisis," Annan added. Annan said that the Global
Fund "needs to spend $3 billion next year, and the current pledges are well
short of that." In its first 18 months of operation, the fund has approved
grants worth $1.5 billion over five years to more than 150 projects in 92
countries (Ngowi, Associated Press, 7/30). President Bush in May signed a
measure (HR 1298) authorizing $15 billion over five years for international
HIV/AIDS programs, with up to $1 billion in fiscal year 2004 going to the
Global Fund. However, the amount of funding actually appropriated to the
fund may be less than $1 billion and is contingent upon the contributions
of other countries. Under the measure, the United States can contribute up
to $1 billion to the fund only if that amount totals no more than one-third
of the fund's total contributions. Therefore, in order for the total $1
billion to be appropriated, other nations must contribute more money
(Kaiser Daily HIV/AIDS Report, 7/15).

Generic Drug Access


Annan said that the World Trade Organization's September ministerial
meeting in Cancun, Mexico, will provide an opportunity for the WTO to
resolve intellectual property conflicts concerning generic drug access,
according to Xinhua News Agency (Xinhua News Agency, 7/30). WTO talks over
generic drug access have been stalled since members missed a Dec. 31, 2002,
deadline to reach an agreement. U.S. negotiators in February refused to
sign a deal under the Doha declaration to allow developing nations to
override patent protections to produce or import generic versions of drugs
to combat public health epidemics, including HIV/AIDS, unless wording was
included to specify which diseases constitute a public health epidemic.
However, the United States in June made a concession by dropping its demand
that the agreement apply only to a specified list of diseases (Kaiser Daily
HIV/AIDS Report, 7/29). At a WTO meeting that ended Wednesday in Montreal,
U.S. Trade Representative Robert Zoellick said he would "make [his] best
efforts" to come to a compromise on the Doha declaration before the WTO's
September meeting, adding that he is hopeful, according to the National
Post. European Union Trade Commissioner Pascal Lamy said that a deal on
generic drugs would have to be reached. "We are all walking on eggs on an
issue that will have to be solved before Cancun," Lamy said, adding, "We
know if it is not solved it is a very bad omen" (Jack, National Post,
7/31). Annan said, "We must reach an agreement allowing those developing
countries that cannot produce cheap generic drugs themselves to import them
from other countries that can" (Xinhua News Agency, 7/30).

5. South African Medicines Control Council Calls for Alternate Nevirapine
Efficacy Data in 90 Days, Could Ban Use of Drug

Access this story and related links online:
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=19136

Officials from South Africa's Medicines Control Council have said that
they will prohibit the use of nevirapine to prevent mother-to-child HIV
transmission unless drug maker Boehringer Ingelheim provides data proving
that the drug is safe, Reuters reports (Quinn, Reuters, 7/30). Last year,
the South African government approved nevirapine for universal distribution
to state hospitals in an attempt to reduce the nation's mother-to-child HIV
transmission rate. The announcement followed a Pretoria High Court ruling
in December 2001 that said that the government must provide nevirapine to
HIV-positive pregnant women through the public health system. The
government appealed the decision, citing concerns over the drug's safety
and efficacy, but the Constitutional Court in July 2002 denied the appeal,
saying that the government's restriction of the drug's distribution to 18
pilot sites "fell short of its constitutional obligation to offer the best
treatment available" (Kaiser Daily HIV/AIDS Report, 10/11/02).

90 Days


MCC officials said that they have "rejected" a 1999 Ugandan study that
showed the drug's efficacy in preventing vertical HIV transmission,
according to Reuters. MCC Chief Precious Matsoso said that the study had
"numerous procedural flaws," and he gave the company 90 days to offer
additional safety and efficacy information (Reuters, 7/30). MCC's concerns
center around reporting and documentation in the Uganda trial, although no
evidence has been found to show that the study's conclusions were invalid
or that any participants had been placed at an increased risk of harm,
Reuters reports (Chege, Reuters, 7/31). Boehringer Ingelheim in March 2002
pulled its FDA application for the right to market nevirapine in the United
States for the prevention of mother-to-child HIV transmission after FDA
regulators said they uncovered procedural problems with the study. The drug
is approved for use in adults in the United States, and the U.S. Public
Health Service Task Force endorses its use for prevention of vertical HIV
transmission (Kaiser Daily HIV/AIDS Report, 7/9/02). In March 2002, FDA
officials said that concerns over the drug's safety were "unwarranted"
(Kaiser Daily HIV/AIDS Report, 3/25/02). If the drug maker fails to
provide alternate data, the government will revoke nevirapine's temporary
approval, Reuters reports. Matsoso said, "We have to be cautious. If
information is available that meets rigorous scientific standards, we will
look at it" (Reuters, 7/30).

Reaction


South African Health Minister Dr. Manto Tshabalala-Msimang at a news
conference yesterday said, "I think [MCC officials] want to emphasize the
same standards that apply to the developed world and the United States
should apply to the developing world." She added, "We can't have double
standards. We can't have something that's only good for Africa and not
good for developed countries" (Reuters/New York Times, 8/1). Kevin
McKenna, a Boehringer Ingelheim spokesperson, said that the company would
attempt to work with the MCC and "eradicate their concerns" about
nevirapine, which earlier this month was endorsed by the World Health
Organization (Altenroxel, Star, 7/30). He added, "The overall scientific
validity of (the Ugandan trial) is not questioned. The scientific
community accepts this single, low dose [of nevirapine] is an appropriate
medication to reduce the risk of mother-to-child transmission." Nathan
Geffen of the South African HIV/AIDS advocacy group Treatment Action
Campaign said, "If new evidence has come to light, the council should make
it available." He added that if the MCC were to deregister the drug, the
government should provide hospitals and clinics with "adequate warning" to
develop alternative treatment plans, according to Business Day (Kahn,
Business Day, 7/31).

SCIENCE & MEDICINE


6. GlaxoSmithKline Issues Letter Saying Not To Use Lamivudine, Abacavir,
Tenofovir Combination as First-Line Therapy

Access this story and related links online:
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=19137

Drug maker GlaxoSmithKline yesterday sent a letter to health care
providers telling them not to use the once-daily, three-drug combination
therapy including the company's antiretroviral drugs Epivir, Ziagen and
Gilead Sciences' Viread as first-line therapy, after the results of a study
showed poor efficacy of the combination, according to the letter (GSK
letter, 7/31). The GSK-led study examined the effectiveness of Viread,
also known as tenofovir, used in combination with Ziagen, known generically
as abacavir, and Epivir, also known as lamivudine, compared with a
combination of Bristol-Myers Squibb's Sustiva, or efavirenz, in combination
with abacavir and lamivudine, Reuters Health reports. GSK found a high
rate of early virologic non-response in patients who had never received HIV
treatment and who took the tenofovir combination. After eight weeks, 49%
of the 102 patients taking the tenofovir combination had failed to respond
to the drugs, and after 12 weeks, 48% of 63 patients met the definition for
non-response, according to Reuters Health. Only 5% of patients taking the
efavirenz combination had failed to respond at eight and 12 weeks. GSK has
yet to determine the reasons why patients failed to respond to the drug
combination, Reuters Health reports. The tenofovir combination arm of the
study has been stopped. The European Medicines Evaluation Agency also
issued a warning to European health care providers telling them not to use
the tenofovir combination following the study results. The agency said
that patients taking the combination should be "frequently monitored with a
sensitive viral load test and considered for modification of therapy at the
first sign of viral load increase." The EMEA also said that patients
taking the combination should talk with their health care providers
"immediately," Reuters Health reports (Woodman, Reuters Health, 7/31).

OPINION


7. Kaiser Daily HIV/AIDS Report Summarizes Editorials on New Preliminary
CDC Data Showing Increase in New AIDS Cases

Access this story and related links online:
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=19138

Several newspapers have published editorials in reaction to new
preliminary data released on Monday by the CDC at the 2003 National HIV
Prevention Conference in Atlanta showing an increase in new U.S. AIDS cases
and the agency's new HIV prevention policy. The data show a 2.2% overall
increase in the number of new U.S. AIDS cases in 2002, compared with 2001.
In addition, the number of new HIV diagnoses among men who have sex with
men rose for the third consecutive year in 2002, increasing 7.1% from 2001
to 2002. HIV diagnoses among MSM have increased by 17.7% since the lowest
point in 1999; however, HIV diagnoses among other high risk groups have
remained stable since 2001. However, fewer people are dying from
AIDS-related causes; the number of AIDS-related deaths dropped 5.9% from
2001 to 2002 (Kaiser Daily HIV/AIDS Report, 7/29). According to a new HIV
prevention strategy announced in April, the government will invest most
heavily in initiatives that focus on identifying people who are already
HIV-positive, which could jeopardize approximately $90 million in annual
federal funding for community groups. The CDC has said that the current
emphasis on community outreach prevention programs has proven ineffective,
citing an increase in the number of new HIV cases (Kaiser Daily HIV/AIDS
Report, 7/30). Summaries of some of the editorials follow:

* Boston Globe: Despite data showing that the HIV/AIDS epidemic is
"growing, not easing," Massachusetts has "radically reduced" funding for
the state Department of Public Health's AIDS Bureau, a Globe editorial
says, adding that in 18 months, the bureau's budget has dropped from $51
million to $28 million. The state budget also shrinks eligibility
requirements for people with AIDS to qualify for treatment coverage under
Medicaid; previously, patients with incomes up to 200% of the poverty level
qualified for the program, but that has been reduced to people with incomes
of up to 133% of the poverty level, according to the editorial. The
message from the CDC and the state's health department "is clear," the
Globe says, concluding, "Retreating on AIDS funding takes a toll in more
AIDS diagnoses and more deaths" (Boston Globe, 7/31).

* Cincinnati Enquirer: The CDC's new HIV prevention policy "correctly
shifts the focus to the most dangerous facet of this deadly disease, but
there is a risk in easing up on successful prevention strategies," an
Enquirer editorial says. The new guidelines will "force" AIDS
organizations to emphasize the importance of regular HIV testing and
educate HIV-positive people about "the fact that AIDS, despite scientific
advances, is still ultimately fatal and easily spread through unprotected
sex," the editorial says. "It's no longer enough to tell people how not to
contract HIV," the Enquirer says, concluding, "We need to start focusing on
what people can do once they have it" (Cincinnati Enquirer, 7/30).

* Indianapolis Star: Prevention is the key to decreasing the number of new
HIV/AIDS cases in the United States, and "helping HIV/AIDS patients curtail
their risks as carriers is eminently sound public policy," a Star editorial
says. Therefore, state health authorities "should follow CDC's lead in
tackling the HIV/AIDS infection rate," the editorial says, adding that the
people who can best reverse the increasing rates are "not those who run the
risk of contracting HIV but those who already have it" (Indianapolis Star,
7/31).

* Virginian-Pilot: Although the number of AIDS-related deaths continues to
decrease, "the rise in overall cases is alarming," a Virginian-Pilot
editorial says, concluding, "A commitment to AIDS education, treatment and
prevention must continue, because the disease hasn't gone away"
(Virginian-Pilot, 7/31).

* Washington Times: Many of the new cases of HIV/AIDS in the United States
"apparently are being initiated by the conscious choice of one individual
to put another at risk, since gay and bisexual men have been so terribly
afflicted," a Times editorial says, adding that "[o]ne need not agree with
the lifestyle to be appalled at this unnecessary waste of life." The
editorial continues, "Gay and bisexual men owe to themselves, not to
mention their families and their friends, to follow basic, life-saving
precautions." The Times concludes, "Capping the potential volcano of an
AIDS explosion will take the conscious choices of those at highest risk"
(Washington Times, 7/31).

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