have been HIV positive since 1983 and tested in 1986. Like many
long term survivors who started nucleoside monotherapy in the late
80’s/early 90’s, I have developed multi-drug resistance
(MDR). Over 40 of my friends have died either of opportunistic infections
or drug resistance. Many of my friends who are living now have under
50 CD4 and are trying to survive. Most of us have added every new
drug as it got approved to failing regimens (what we call sequential
or virtual monotherapy), which rendered them useless in a few weeks
or months. Most of us are taking drugs that we have resistance to
in hopes that they keep viral replication capacity (viral fitness)
down. Many of the people who show up to my lectures are also going
through this problem, yet all we hear in the media and conferences
is how well people with HIV in the developed world are doing!
When first searching for an effective regimen to treat my multidrug
resistant HIV, I spent over 18 hours on the INTERNET trying to find
out what my options were. Not a single web site summarized this
life saving information. That is why I decided to create this web
After 21 years of the AIDS epidemic, 20 new drugs belonging to five
drug classes are available in the US. As a result, mortality and
morbidity have decreased significantly in the HIV infected patient
population. Unfortunately an increasing number of patients living
with HIV are developing resistance to all available nucleosides,
non-nucleosides, protease inhibitors and the latest fusion inhibitor
(Fuzeon), making it impossible for them to construct viable drug
combinations for effective control of HIV replication. Of an estimated
400,000 people under treatment for HIV in the United States, 14-20%
of these may have multi-drug resistance (MDR). This means that as
many as 80,000 patients are running out of life saving options,
increasing the risks of opportunistic infections and death. Additionally
an estimated 40,000 new HIV infections occur in the US annually.
Up to 14% of these, or 5600 patients per year, have acquired resistance.
Clinical guidelines dictate
that at least two and preferably three active agents need be present
in a drug combination for MDR patients. Unfortunately, these new
drugs have been only available in a sequential monotherapy manner
in the past (adding one “active”drug to a failing combo)
through clinical research. No studies allow the use of other investigational
agents, making it impossible in many cases for MDR patients to avoid
sequential monotherapy. This approach encourages further development
of drug resistance in patients participating in such research protocols.
Access to investigational
drugs through studies can be complicated by strict genotype inclusion/exclusion
criteria or geographical limitations. Also, the patients in most
need (with under
CD4 cells) are not allowed in Phase II and III studies. Furthermore,
those patients co-infected with Hepatitis B or Hepatitis C (30 %
of the HIV population), or having increased liver enzymes find themselves
barred from drug studies. Many of these excluded patients are those
most in need of multiple new active agents. They do not have the
luxury of waiting for later. Expanded access programs of drugs before
approval are limited to those physician practices that are willing
to do the lengthy paper work with lmited reimbursement for their
time. Many academic institutions and public hospitals refuse to
be part of EAP networks because of that reason.
If you need help or information about how to access new drugs or
expanded access programs in your area, please email Nelson Vergel
Do not make costly mistakes when starting a new drug combo...get
informed, after all it is your life!