New NIH Guidelines Mark ‘Significant’ Change in Timing of Treatment Initiation
New National Institutes of Health guidelines on AIDS treatment slated to be issued next month will advocate "caution and delay" in administering highly active antiretroviral therapy, or HAART, to HIV-positive individuals, a "significant" change from current standards, Newsday reports. Since 1996, NIH has adopted a "hit early, hit hard" approach to tackling HIV infection in patients by encouraging the use of HAART in patients in the early stages of infection. Now, however, NIH is recommending that physicians only use HAART on patients with a CD4 T cell count below 350 cells per milliliter of blood, as opposed to the current level of 500 cells per milliliter. The new guidelines also urge physicians to wait to administer HAART until a patient has 30,000 viral particles per milliliter of blood, as measured by branch DNA analysis, an increase from the previous viral load cutoff of 10,000 per milliliter. The decision to revise the guidelines stems from scientists' concerns with toxicity and resistance problems associated with HAART. The longer patients take the HAART combinations, the greater the chance that the drugs' efficacy will decrease and the greater the chance that the patient will experience side effects from the drugs. Potential side effects include death of hip bone tissue, increase in blood cholesterol levels, loss of nerve sensations, kidney failure, pancreas failure, liver dysfunction and severe anemia.
Drug Combo Drawbacks
While HAART has benefitted HIV-positive patients in numerous ways, some physicians and AIDS activists question the therapy's ultimate effectiveness, and some feel that the drawbacks outweigh the gains. New research, based on mathematical modeling, has shown that to be "completely effective," or in other words a cure, an HIV-positive individual would have to take HAART for at least 70 years to rid their bodies of the virus. However, "most" patients develop "drug-resistant" forms of HIV, rendering the drugs ineffective, and therefore a HAART-induced cure impossible to achieve. The FDA has considered "weakening" drug testing requirements in order to add more medications to the list of HAART drugs, but this effort has met opposition from some AIDS activists. Gregg Gonsalves, policy analyst for Gay Men's Health Crisis, said, "I would argue that the drug companies and the [FDA] have been negligent, retrospectively, in not conducting or requiring long term studies of the effects of these drugs ... the drug companies are laughing all the way to the bank." Dr. Michael Saag is also "worried" about the side effects of antiretroviral drugs, but remains "hopeful" that scientific research will find a way to eliminate them, leading to "much-needed improvements" in drug therapy (Garrett, Newsday, 1/17).