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Hi all,
Just to let you know that our annual TAG/HIV iBase Pipeline Report is now
out.
Cheers,
Colleen


   *FOR IMMEDIATE RELEASE:*
*Sunday 30 June 2013 – 4 a.m. GMT* *CONTACT: *Lei Chou (NY) +1.917.355.3684
Polly Clayden (KL) +44 7764 950 296
Tim Horn (KL) +1.917.407.8526



 *HIV i-Base/Treatment Action Group 2013 Pipeline Report *
*calls on leaders to get the best HIV, hepatitis C virus (HCV), and
tuberculosis drugs, diagnostics, and vaccines to the most people as quickly
as possible*

*– Survey shows HIV pipeline healthy, HCV drug development surging,*
*while TB research moves forward much too slowly –*

*– Faster research, approval, and access demanded –*

KUALA LUMPUR, Malaysia, 30 June 2013 – HIV i-Base and Treatment Action
Group (TAG) called on global and national leaders, research sponsors, and
regulatory authorities to work together to make the best HIV, HCV, and TB
drugs, diagnostics, and vaccines accessible as fast as possible, according
to a report released today at the 7th International AIDS Society (IAS)
Conference on HIV Pathogenesis, Treatment and Prevention in Kuala Lumpur,
Malaysia.

In the* 2013 Pipeline Report*, Polly Clayden of HIV i-Base (UK) and Mark
Harrington of TAG (USA), set a seven-part agenda to speed the best medical
products to all who need them everywhere. They call for research funders to
continue investing in better products and to address global needs up front
in their development. They demand that regulators expedite review of new
medications in developing countries and close approval gaps between rich
and poor countries and adult and pediatric indications. World Health
Organization (WHO) and national guidelines groups must continue
streamlining and simplifying treatment guidelines, they stress. Clayden and
Harrington urge authorities in developing and developed countries to speed
the rational use of the best possible drug combinations regardless of
patent status or manufacturer and to expedite the transition to
high-quality first-line generic products when preferred drugs go off patent.

Noting that the pharmaceutical industry has made billions from successful
HIV therapies in the past two decades, Clayden and Harrington report that
in the last decade alone, 47 new drugs and combinations were studied in
phases II and III. An impressive 34 percent (16/49) were approved by the
U.S. Food and Drug Administration (FDA), with 6.4 percent (3) awaiting
approval and 21 percent (10) moving forward in phases II or III. “To get
the best drugs to the most people as quickly as possible, global and
national health leaders, regulators, and research sponsors must take
concerted action to speed up the approval of pediatric, generic, and
high-quality cross-sponsor fixed-dose combinations—as soon as they are
available in rich countries—in those where they are needed most,” commented
Clayden and Harrington.

Themes of the 2013 “Antiretroviral Pipeline” by Simon Collins (HIV i-Base)
and Tim Horn (TAG) include the continuing wave of innovations bringing
broader, and in some cases better, treatment options for people with HIV.
They note “the possible conflicts these innovations will encounter due to
global economic austerity.” Collins and Horn underscore “the potential for
combining generic antiretrovirals as they move off-patent in many developed
countries with innovator compounds to produce synergistic, often
cross-sponsor, combinations and fixed-dose combinations (FDCs) that could
offer people with HIV the best of the new and the old while saving
cash-strapped health systems billions of dollars.”

Noting the current decade’s coming wave of patent expiries on first-line
HIV drugs such as efavirenz and tenofovir, Collins and Horn note that,
“savings from generics are essential if we are to retain public health
services for those who remain uninsured or underinsured.” They call for
generic manufacturers and governments to seize the opportunity posed by the
coming wave of patent expiries to offer optimal combinations at prices much
lower than for innovator compounds. It will be critical for rich and poor
countries, to reinvest the savings generated by sensible use of
generic-containing antiretroviral combinations into massively expanded HIV
prevention and treatment programs to end HIV transmission and progression
to AIDS and death and achieve an “AIDS-free generation” for everyone.
.
In back-to-back chapters on pediatric HIV drugs and HIV treatment
optimization, Polly Clayden calls for continued streamlining and
rationalization of adult and pediatric HIV formulations and notes
innovative partnerships such as those recently supported by the Drugs for
Neglected Diseases Initiative (DNDi) and UNITAID to expedite production of
optimized regimens for children. Clayden stresses the importance of
developing generic combinations with the best target product profiles.
“It’s time to move on from merely providing the world’s poor people with
the cheapest medicines and time to give them the best – safest and most
effective – treatments possible, and make them affordable” says Clayden.

Richard Jefferys (TAG), in his broad survey of research developments on
preventive technologies, research toward a cure, and immune-based and gene
therapies, calls for intensified basic and translational science on
potential HIV vaccines and continued research on antiretroviral (ART)-based
pre- and postexposure prophylaxis (PrEP, PEP). He stresses the need for
immune-based therapy research to raise CD4 T cell counts among immunologic
nonresponders to HIV therapy, and new research to address ongoing residual
dysfunction of the immune system that persists in people on successful ART.
Finally, Jefferys emphasizes further investigation of the role of very
early treatment with potent ART combinations in infants and adults infected
with HIV; better lab measurements to quantify the cells and tissue sources
of the latent HIV-1-infected cell reservoir, the target for HIV cure
research; and exploration of the potential contribution of therapeutic
vaccine approaches as part of combination curative therapy.

In the 2013 “HCV Treatment Pipeline,” Tracy Swan (TAG) notes that the
“confluence of a robust HCV drug pipeline, shortened regimens, and
[shorter] posttreatment follow-up are extraordinary. The new FDA
breakthrough therapy designation may speed things up as well. By the end of
2014, [new HCV drugs] from four different classes and fixed-dose
combinations (FDCs) are likely to be approved by the U.S. Food and Drug
Administration (FDA) and the European Medicines Agency (EMA), offering the
potential for off-label mixing and matching.” An impressive 26 new HCV
drugs are being studied in phases II/III in at least 28 interferon-free
regimens, which are bringing the potential of faster, all-oral HCV cures
rapidly toward approval for the world’s 185 million people living with HCV.

Swan notes, however, that not all optimal combinations are being studied,
with some sponsors preferring combinations of their own proprietary
compounds, while many sponsors take too long to study their new drugs in
people coinfected with HIV and HCV, and those with cirrhosis.

In her companion chapter, “Low- and Middle-Income Countries Defuse
Hepatitis C, the ‘Viral Time Bomb,’” Karyn Kaplan (TAG) describes how a
worldwide movement is forming to ensure that when new all-oral HCV cures
are approved, that governments, health systems, and providers will be ready
for them. Kaplan points to recent progress instigated by HCV activists in
countries such as Egypt, Georgia, Thailand, and Ukraine.

In three chapters on tuberculosis (TB) diagnostics, treatment, and vaccine
research, Colleen Daniels, Erica Lessem, and Mike Frick (TAG) find that
lack of investment and political will make the TB pipeline the most anemic
covered in the *2013 Pipeline Report*.

Globally, one-third of active TB cases are never diagnosed, reported, or
treated, meaning that 3 million people are walking around with undiagnosed
disease, in danger of progression, death, and onward transmission.

Some progress has been made in rolling out new DNA tests, which can detect
TB more rapidly. The tests still require high-tech laboratory equipment,
electricity, and trained personnel though, meaning they are far from the
majority of TB patients and those at risk. Manufacturers are trying out
cheaper forms of DNA TB diagnostic testing with as yet little published
data, and faster ways to detect TB mutations, which are associated with
resistance to TB medications.

TB treatment is slowly moving forward following the first FDA approval of a
new drug from a new class in over 40 years, and innovative combination TB
studies under way for both drug-sensitive and drug-resistant disease. Most
countries are not ready to review, approve, distribute, and assure rational
use of new TB drugs and combinations, however, reinforcing HIV i-Base and
TAG’s call for high-burden countries to modernize their regulatory research
oversight and approval programs.

Research on TB vaccines remains slow and underfunded but there are some
glimmers of hope, particularly on the basic science and early clinical
front. Much more investment is needed in TB research and development
overall, and in TB program scale-up to ensure access to the best
diagnostics tests and preventive and curative therapies.

# # #

The HIV i-Base/Treatment Action Group *2013 Pipeline Report: HIV, Hepatitis
C Virus (HCV), and Tuberculosis (TB) Drugs, Diagnostics, Vaccines,
Preventive Technologies, Research Toward a Cure, and Immune-Based and Gene
Therapies in Development* by Polly Clayden, Simon Collins, Colleen Daniels,
Mike Frick, Mark Harrington, Tim Horn, Richard Jefferys, Karyn Kaplan,
Erica Lessem, and Tracy Swan, edited by Andrea Benzacar, Tim Horn, and
Scott Morgan, is online at:

            http://www.treatmentactiongroup.org/pipeline-report<http://cts.vresp.com/c/?T...
.

and as an interactive web report at:

            http://www.pipelinereport.org@@http://cts.vresp.com/c/?TreatmentActionGroup/b...
.

------------------------------

*About HIV i-Base* – HIV i-Base is a London-based HIV treatment activist
organization. HIV i-Base works in the United Kingdom and internationally to
ensure that people living with HIV are actively engaged in their own
treatment and medical care and are included in policy discussions about HIV
treatment recommendations and access.

http://www.i-base.info@@http://cts.vresp.com/c/?TreatmentActionGroup/bc74d9fd...

*About TAG – *Treatment Action Group (TAG) is an independent AIDS research
and policy think tank fighting for better treatment, a vaccine, and a cure
for AIDS. TAG works to ensure that all people with HIV receive lifesaving
treatment, care, and information. We are science-based treatment activists
working to expand and accelerate vital research and effective community
engagement with research and policy institutions. TAG catalyzes open
collective action by all affected communities, scientists, and policy
makers to end AIDS. TAG is a nonprofit, tax-exempt 501(c)(3) organization.

http://www.treatmentactiongroup.org@@http://cts.vresp.com/c/?TreatmentActionG...>

 
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