FDA Approves Urine Test for HIV: The FDA approved the first urine
test for detection of HIV antibodies on August 6, 1996. This test is available
from Calypte Biomedical Corp. in Berkeley, CA. The obvious advantage of this
test is that it avoids the necessity for venipuncture. This test shows
false-negative results in 1-2% and false-positive results in 1-2%. Persons with
positive tests should have confirmation using standard serology. For more
information call 800-428-4007.
HCFA Letter to State Medicaid
Directors Concerning Payment for Protease Inhibitors: On June 19, 1996,
Sally K. Richardson, Director of the Medicaid Bureau, sent state Medicaid
directors a letter advising them about appropriate coverage of the three
FDA-approved protease inhibitors. In brief, it was noted that "states are
required to cover medically accepted indications of FDA-approved drugs."
It was also noted that states have the discretion to establish certain
limitations on the provision of drugs, but that "the effect of such
limitations on Medicaid HIV/AIDS-infected patients can have serious
ramifications, including emergence of resistance if such drugs are
States are warned that limitations should not excessively or unreasonably
restrict coverage of this treatment. Furthermore, if states include drugs in
managed care, protease inhibitors must be available in managed care
formularies, and there should be an analysis to determine whether capitation
rates should be adjusted accordingly.
ADAP and Protease
Inhibitors: The National Association of State and Territorial AIDS
Directors surveyed AIDS Drug Assistance Programs in September 1996. Of 54 states
and territories receiving Ryan White Title II funds, 26 included all three
protease inhibitors in their formularies. Fifteen states covering protease
inhibitors anticipate budget shortages of $16 million by April 1, 1997. The
ADAP Working Group anticipates that ADAPs will need $436 million to cover
protease inhibitors for FY '97.
Severe Renal Impairment with
Cidofovir: Gilead Sciences Inc. issued a drug warning in September 1996
concerning "several reports of severe renal impairment associated with the
use of cidofovir (Vistide)." Risk factors are preexisting renal disease
or recent exposure to aminoglycosides. Additionally:
- The drug is contraindicated in patients with serum creatinine
mg/dL, creatinine clearance < 55 ml/min or 2+ proteinuria.
- Co-administration of nephrotoxic drugs is contraindicated, including
non-steroidal anti-inflammatory agents, amphotericin B, aminoglycosides and IV
pentamidine; there should be a seven day "washout" following the use
of these drugs.
- Oral probenecid and intravenous prehydration with saline reduces
Cases of nephrotoxicity should be reported to Gilead Sciences, Inc.
(800-GILEAD-5) or to the FDA's Medwatch (800-FDA-1088).
(Viracept) Expanded Access Program: Agouron Pharmaceuticals Inc. has
announced an expanded access program for nelfinavir, a new protease inhibitor.
Prior studies showed good tolerance of this drug in combination with stavudine
(d4T) or with zidovudine (AZT) plus lamivudine (3TC). The expanded access
program will provide nelfinavir; all other drugs and medical care costs will be
the patient's responsibility. The intent is to supply drug to all patients who
meet enrollment criteria, although a "pacing procedure" may be used.
Entry criteria are:
- 1. CD4 count < 50 cells/mm3
- Unable to use alternative FDA approved protease inhibitors (saquinavir,
indinavir, or ritonavir) due to intolerance, contraindication or prior
- Age > 13 years;
- Agreement of provider to comply with the protocol;
- No prior treatment with nelfinavir. For more information, call
Somatotropin (Serostim) Approved by the FDA: Recombinant Human
Growth Hormone (somatotropin, Serostim), marketed by Serono Labs, has been
approved by the FDA. The usual 12 week regimen is 6 mg/day for patients > 55
kg., 5 mg/day for patients 45-55 kg., and 4 mg/day for patients 35-45 kg., by
subcutaneous injection and preferably at bedtime to approximate the natural
secretory pattern of pituitary growth hormone. One clinical trial (# 5341) with
178 participants (mean weight loss 22 lbs.) showed an average weight gain of
6.6 lbs. after 12 weeks of treatment. There was also a significant improvement
in functional performance as measured by treadmill work output. Another trial (#
7033) with 177 patients (mean weight loss 24 lbs.) showed similar changes in
weight, improved quality of life, and no significant change in CD4 cell count or
in plasma HIV RNA. Side effects are infrequent and consist primarily of
musculoskeletal discomfort. The duration of treatment in trial was 12 weeks.
The FDA is requiring a study of maintenance doses since this in-formation is not
available. Cost is a concern, but the AWP has not yet been determined.
Fansidar Available: Roche labora-tories has reintroduced
pyrimethamine/sulfadoxine (Fansidar) which is sometimes used for P. carinii