I 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 site.

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

50 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.

Fortunately, there are new medications in the integrase inhibitor and the CCR5 antagonist classes that are now available to patients in the US and some parts of Europe. These new agents will help those who have run out of options but will also present challenges to physicians to construct viable regimens that have maximum efficacy, minimum side effects and drug-drug interactions. And lastly, the cost and access of these new agents may be challenging to many public systems.

If you need help or information about how to access new drugs or expanded access programs in your area, please email Nelson Vergel at nelsonvergel@yahoo.com

Do not make costly mistakes when starting a new drug combo...get informed, after all it is your life!

In health,

Nelson Vergel
BsChE, MBA
Founder

• Announcements
• Research Principles
• ACRIA Clinical Trials Information
• 2004 AntiVirals Pipeline
• AIDSMap: Salvage Therapy Index
• HivandHepatitis.com
• TheBody.com: Salvage Therapy Information
• NATAP.org

PoWeR provides lectures, online help, different web sites and discussion groups, and technical assistance for HIV wellness programs for improving long-term survival to any HIV(+) person for free. We have no paid staff.

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