AIDS TREATMENT NEWS No. 110 - September 7, 1990
Michelle Roland

Astra's expanded access program is basically an individual compassionate use protocol which requires that each patient's request for the drug be approved by both Astra and the FDA. According to Astra spokesperson Pat Williams, the application process should take one to three days to complete, at which time the drug will be Federal Expressed to the physician. It does require the physician's willingness to order lab tests, monitor the patient clinically, and complete necessary initial and on-going paperwork. It also requires three days of hospitalization to monitor allergic or other adverse reactions.

Like Bristol-Meyers' ddI expanded access program, Astra's program requires that patients requesting foscarnet not be eligible for any clinical trial with the drug, whether that trial is sponsored by Astra, the government ACTG (AIDS Clinical Trial Group) program, or any other sponsor. Patients and physicians should call 1-800-TRIALSA to determine if there are clinical trials for which the patient would be eligible within a reasonable geographical area.

Eligibility Criteria for People with CMV

Three categories of patients with CMV retinitis may qualify for foscarnet through expanded access:

1) Patients who have been diagnosed with CMV retinitis who are ineligible for ganciclovir (also known as DHPG) therapy because of current and on-going myelosuppression (neutrophil count <500 cells/ml or platelet count <50,000/ml) or hypersensitivity to ganciclovir. Note that Ms. Williams indicated that there would be some flexibility in the required neutrophil count if the physician felt that failure could be documented with more than 500 cells/ml (up to 750 cells/ml) and that continued treatment with ganciclovir would be dangerous to the patient.

2) Patients on ganciclovir who are experiencing ganciclovir toxicity (neutrophil count <500 cells/ml or platelet count <50, 000/ml or other dose limiting toxicities considered on an individual basis) during either the induction or maintenance phase of treatment. Again, there will be some flexibility with the neutrophil count as described above.

3) Patients on ganciclovir therapy who are experiencing progression of their retinitis during induction or the first two weeks of maintenance therapy. Astra will require re-induction with ganciclovir in patients who are failing maintenance more than two weeks after their last induction phase. Ms. Williams stated that they want to ensure that ganciclovir failure has occurred before providing foscarnet to this group of patients.

Studies for which patients with CMV retinitis may be eligible include an Astra sponsored study in Houston for ganciclovir failure. All other studies with foscarnet at this time are comparative studies using ganciclovir in some patients and so should not interfere with eligibility for expanded access. (For more information call 1-800-TRIALSA about ACTG 129, and about a Phase I study at the National Eye Institute using laser therapy and ddI with foscarnet or ganciclovir.)

Patients with other manifestations of CMV infection, including colitis, pneumonia, hepatitis and encephalitis, who are not responding to or cannot tolerate ganciclovir may also qualify for this program. Ms. Williams encouraged the doctors of such patients to call Astra.

Eligibility Criteria for Acyclovir Resistant Herpes

Patients must have experienced no improvement in their herpes lesions after at least ten days of intravenous acyclovir therapy at a dose of 10 mg/kg every eight hours. Alternatively, acyclovir resistance can be demonstrated by an in vitro resistance test.

Patients must not be eligible for (or able to get to) Astra's studies in Los Angeles or Houston on acyclovir resistant herpes.

Additional Requirements for Women

All women must have a negative pregnancy test and agree to use contraception during treatment and for three months following treatment. The supply of foscarnet will be stopped if a female patient becomes pregnant. When asked about evidence of teratogenicity (harm to the fetus) with foscarnet, Ms. Williams stated that there is no evidence of danger in animal studies but that no human data exist about effects on the fetus. Note that this is the usual process in the U.S. with respect to testing drugs in women; i.e., the drug gets approved with either very little or no experience in women and the specific effects on women and fetuses are discovered in post marketing studies or during clinical experience.

Physician Responsibility

The physician must be willing to complete a case report form and regulatory paperwork. Ms. Williams estimated that the total time required for paperwork would be about 1 hour in the first week and 20 minutes weekly for the duration of the treatment. The physician must have hospital privileges; hospital review board approval is also required. The people at Astra are concerned about physicians lying about kidney problems in their patients in order to get them foscarnet since foscarnet's major side effect is on renal function. Ms. Williams suggested that if a physician is found to be lying about significant clinical or lab history, future applications by that physician may be denied.

Costs

The drug is supplied at no cost and any "special studies" required by Astra will be paid for by them. However, the first three days of treatment must be administered in the hospital in order to monitor acute toxic or allergic reactions. All hospital associated costs must be paid for by insurance or the patient. In addition, routine lab work, also required by Astra, must be paid for by the insurance company or the patient. During the induction phase of treatment, this lab work is required approximately three times per week. It is required approximately every two weeks during maintenance therapy. In the case of CMV retinitis, routine monitoring includes eye exams. Photography is not required, but is requested by Astra for both retinitis and herpes.

Note

ACT UP/Boston (617/492-2887) and AIDS activists elsewhere have worked for 18 months to make compassionate access to foscarnet available. This drug was first proposed as an AIDS treatment many years ago. It has suffered a long and tortuous history on its way to acceptance.

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