Hardy WD, Chafey S, Tan C, Bryson Y, Mroz J, Martin-Manley S; International Conference on AIDS.

Int Conf AIDS. 1991 Jun 16-21; 7: 258 (abstract no. W.B.2304).

UCLA AIDS Clinical Research Center, Los Angeles, CA

OBJECTIVE: To assess the safety and comparative efficacy of two PFA induction regimens as well as requirements for postinduction maintenance Rx for ACV-R infections in AIDS patients. METHODS: Nine AIDS patients with persistent mucocutaneous HSV infections (7 - perianal, 2 - facial) well-documented to be both clinically and virologically (ID50 greater than 25uM) ACV-R have received PFA treatment. The first was a pilot patient for PFA Rx; eight subsequent patients were randomized to receive PFA induction regimens of 40 mg/kg IV q 8h (N=4) of q 12h (N=4) x 14-21 days, and to PFA maintenance Rx dosed at 40/mg/kg/d (N=4) or observation (N=3) following healing of HSV lesions. Time to clinical healing and cessation of virologic shedding and recurrence of HSV lesions and shedding as well as safety parameters have been monitored. RESULTS: Cessation of HSV shedding occurred at days 4, 4, 5, 7 for the four q8h-Rx'd patients, and at days 5, 5, 6, 7, for the four q8h-Rx'd patients. Time to complete or greater than or equal to 80% healing of HSV lesions occurred by days 14, 21, 28, 49 for the q8h-rx'd patients, and by 14 days for all four q12h-Rx'd patients. Length of induction PFA Rx was highly dependent upon initial lesion size which ranged from 2 x 3 cm to 30 x 35 cm. Maintenance Rx prevented recurrence of HSV lesions and viral shedding in all four Rx'd patients for greater than or equal to 10 wks. Time to recurrent HSV lesions and viral shedding in the three patients without maintenance Rx was 2, 3, 6 weeks, respectively. Re-induction Rx has been successful in all Rx'd patients. One patient developed severe renal insufficiency (creat greater than 5.0 mg/dl) after prolonged induction Rx; one patient developed anemia requiring transfusion. Minor, reversible fluctuations in serum Ca++, Mg++, and PO4- have been seen in all patients. CONCLUSION: PFA induction Rx is safe and effective for ACV-R HSV in AIDS patients with q8h or q12h regimens. Maintenance Rx effectively suppresses recurrent HSV lesions and is well-tolerated. Re-induction Rx has been successful in all cases. No evidence of PFA-resistant HSV has been seen.

Publication Types:

• Meeting Abstracts

Keywords:

• AIDS-Related Opportunistic Infections
• Acquired Immunodeficiency Syndrome
• Acyclovir
• Foscarnet
• Herpes Simplex
• Humans
• Infection
• Simplexvirus
• therapy

Other ID:

• 3230491

UI: 102192909

From Meeting Abstracts