World Health Organization Publishes New Guidance on Second-Line Anti-HIV Therapy
in Resource-limited Settings
Effective
antiretroviral therapy has dramatically
reduced rates of illness and death in wealthy countries, and does so in low- and
middle-income countries as well when treatment is available to those who need
it. People with HIV in resource-limited settings,
however, often lack access to second-line therapies that can be used after an
initial regimen fails.
The
World Health Organization (WHO) recently published a report on strategic approaches
to formulating second-line treatment regimes in resource-limited countries, based
on a meeting held in May 2007.
Following
is the executive summary of the WHO report and a link to the complete document:
Executive
Summary
Introduction
Antiretroviral
[ARV] therapy [ART] has dramatically improved the survival of HIV infected individuals
and is critically needed to save millions of lives. As resource-limited countries
rapidly expand their HIV/AIDS treatment programs, increasingly countries are faced
with the need to make second-line ART regimens available.
The
2006 WHO ARV treatment guidelines outline the strategic approaches that should
inform updated national treatment guidelines for first- and second-line therapies,
and outline which agents should be considered for use in first line and second
line. National programs, however, are requesting additional operational guidance
on the composition of their second line ART formularies based on programmatic
efficiencies and costs.
As
the ARV formulary is generally limited in developing countries, there is an increasing
and urgent need for principles and criteria by which to prioritize ARV options.
Regulatory bodies both nationally and internationally (e.g. the WHO pre-qualification
project) are also requesting guidance on how to select the most needed therapeutic
ARV agents for rapid appraisal.
WHO
therefore convened an expert meeting to review the scientific evidence and programmatic
data available, in order to develop guidance for national programs, regulatory
authorities and implementing partners on selection, prioritization and planning
for second-line ARV drugs.
Meeting
objectives
The
experts group guided by existing WHO recommendations for ART were requested to:
•
Examine programmatic experience in establishing and using second-line ARV agents
in national formularies;
•
Review data on cost, supply and procurement of, and the range of ARV drugs currently
used for second-line ART within national treatment programs focusing on low and
middle-income countries;
•
Review existing and projected needs for and costs of second-line regimens, based
on forecasts for second-line ARV use, and implications for national programs;
•
Develop
key principles to guide rational selection of preferred second-line ARV drugs;
•
Develop
a list of priority second-line ARV products as recommended by WHO in ART treatment
guidelines for use by regulatory authorities, drug manufacturers, national treatment
advisory committees, implementing agencies and authorities responsible for drug
forecasting and procurement.
Working
Methods
The
meeting was conducted over two days. Plenary sessions reviewed current WHO recommendations
for second-line ART in low and middle income countries, and programme experience
to date, and data on cost, supply, and procurement of ARVs Group work was the
used to develop prioritization and recommendations for a final list of priority
products proposed, which were then reviewed and finalized in plenary sessions
Outcomes
The
working group participants were able to develop consensus on the preferred recommended
NRTI background options for second line ART, with two combinations rated as highest
priorities. These were TDF [tenofovir;
Viread] + 3TC [lamivudine; Epivir]
and ABC [abacavir; Ziagen] + ddI
[didanosine; Videx].
For
the PI [protease inhibitor] component, based on comparable clinical efficacy safety
data the working group agreed ranked LPV/r
[lopinavir/ritonavir; Kaletra] and ATV/r
[ritonavir-boosted atazanavir; Reyataz] as the highest priorities.
These
ARV options are therefore the ones among those recommended in WHO treatment guidelines
that producers, development partners, funding agencies and regulatory authorities
should be encouraged to make available to national programs.
Link
to full report (43 pages in PDF format)
2/15/08
Source
World Health
Organization. Prioritizing Second-Line Antiretroviral Drugs for Adults and Adolescents:
A Public Health Approach. Report of a WHO Working Group Meeting. May 21-22, 2007.
