Gay Men's Health Crisis Treatment Issues, Vol. 5, No. 9, December 1991
Mike Barr

The whole procedure is usually performed on two consecutive days at monthly intervals and takes about four hours per session. Photopheresis has been used to treat various autoimmune diseases and is an approved therapy for a specific skin cancer that is called cutaneous T-cell lymphoma. In the test tube photopheresis works to inhibit viruses which involve RNA and DNA, including HIV. [2]

The company developing this potential treatment is Philadelphia-based Therakos, a subsidiary of the Johnson & Johnson Company of Raritan, NJ. The small pilot study was conducted at Memorial Hospital in Morristown, New Jersey, under the direction of Dr. Emil Bisaccia.

DATA FROM A FIVE-PERSON STUDY

As was reported last year, four of the five participants in the Morristown pilot study were said to have experienced either a stabilization" or an "encouraging response" to the photopheresis treatment. Swollen lymph nodes resolved in all five patients by the third month of therapy and have not since recurred, three years later. None of the five patients has taken AZT or any other antiviral or immune modulating therapies. Two participants, however, are taking medication to prevent PCP.

After three years of photopheresis treatment, skin reactions returned to normal in all four patients, and no toxicity was observed. Additionally, on average T4 cell counts rose from 251-486. T4 cell percentages rose on average from 19%-30%. Beta-2 microglobulin decreased on average from 5 mg/L to 3 mg/L. However, neopterin levels increased from approximately 14 to 20.

DATA FROM A FIFTEEN-PERSON STUDY

A second, slightly larger group of 15 participants entered into photopheresis treatment at Morristown Memorial Hospital in May, 1990. While, once again, swollen lymph nodes resolved in all trial participants, neither the average T4 cell count nor the average T4 percentage increased during the period of treatment.

In fact, results conflicted with the original smaller group of participants and were somewhat discouraging. For example, T4 counts fell from 401 to 325 and percentages dropped from 30% to 27%, while beta-microglobulin rose from about 2.10 to 2.83. Ability to respond to skin tests did return to normal in eight participants, as in the original study group of five, and improved in others. As was the case m the initial pilot study, none of the trial participants was taking AZT or other antiviral/immune modulating substances. Again no toxicity was observed.

WHAT DOES IT MEAN?

When asked to comment on the inconsistent study results, Dr. Bisaccia stated that the data indicated a need for further study of the treatment in HIV infection. The question of an application for photopheresis as a treatment for HIV is "clearly not a concluded story," he added.[3]

And at a recent Columbia University-sponsored medical symposium in New York where he presented the most recent data, Dr. Bisaccia seemed undaunted but unable to conceal completely his disappointment with the results so far. "If this therapy is ever to prove efficacious in the treatment of HIV disease," he noted, "it will take us a long time to gain such approval. Clinically, patients look very good. And at the very least this procedure appears to be safe. But we cannot say that we have data showing evidence of efficacy."[4]

WHAT'S THE HOLD UP?

At the time of this report, Therakos is in the process of designing a phase II study with the FDA for people with HIV. According to FDA sources, the trial is pending Therakos' next move, since regulators have asked the company to elaborate on various microbiological and virological aspects of the treatment. Therakos has not yet produced the information. There may also be some concern on the part of the FDA over the inconsistency of T4 changes between the two groups participating in the Morristown studies. Apparently, several different labs were used during the study, and so results may include muddy" data.

Finally, Therakos' parent company, Johnson & Johnson, filed a New Drug Application (NDA) back in January, 1991, to use this method of photopheresis in the treatment of scleroderma, an autoimmune disease of the skin. Treatment activists monitoring the progress of photopheresis research for HIV infection speculate that Therakos will be reluctant to pursue the HIV angle any further until the FDA has taken action -- either licensing or rejecting -- the 2-year-old NDA for scleroderma.

When asked about future plans for HIV-related research, a spokesperson for Therakos said that the company needed to review data from the Morristown study before deciding to proceed in other treatment areas.

REFERENCES

1. Torres G. Photopheresis. Treatment Issues (4) 7:5, 1990.

2. Bisaccia Emil et al. Extracorporeal photopheresis in the treatment of AIDS-related complex: A pilot study. Ann Int Med 113(4):270-275, 1991.

3. Bisaccia E. Personal Communication, October, 1991.

4. Bisaccia E. Photopheresis in HIV disease. HIV & Skin Disease: Issues in Diagnosis & Management. Columbia University College of Physicians & Surgeons, New York City, October, 1991.

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