The Hopkins HIV Report
A bimonthly newsletter for healthcare providers
Volume 8, Number 4, November 1996

Product Information

By John G. Bartlett, M.D.

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 discontinued." 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:

  1. The drug is contraindicated in patients with serum creatinine levels >1.5 mg/dL, creatinine clearance < 55 ml/min or 2+ proteinuria.

  2. 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.

  3. Oral probenecid and intravenous prehydration with saline reduces nephrotoxicity.

Cases of nephrotoxicity should be reported to Gilead Sciences, Inc. (800-GILEAD-5) or to the FDA's Medwatch (800-FDA-1088).

Nelfinavir (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. 1. CD4 count < 50 cells/mm3

  2. Unable to use alternative FDA approved protease inhibitors (saquinavir, indinavir, or ritonavir) due to intolerance, contraindication or prior failure;

  3. Age > 13 years;

  4. Agreement of provider to comply with the protocol;

  5. No prior treatment with nelfinavir. For more information, call 800-621-7111.

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 prophylaxis.

This article is from The Johns Hopkins University AIDS Service,
The Hopkins HIV Report: A bimonthly newsletter for healthcare providers.