[28] VIROLOGICAL RESPONSE IN RESERVOIRS IN HIV-INFECTED NAIVE PATIENTS TREATED WITH COMBIVIR PLUS NELFINAVIR (CNF) OR NEVIRAPINE (CNR).

1st International AIDS Society Conference on HIV Pathogenesis and Treatment

Buenos Aires, Argentina - July 8-11, 2001

[TITLE:] VIROLOGICAL RESPONSE IN RESERVOIRS IN HIV-INFECTED NAIVE PATIENTS TREATED WITH COMBIVIR PLUS NELFINAVIR (CNF) OR NEVIRAPINE (CNR).

[AUTHOR(S):] FERRER E, PODZAMCZER D, PEREZ P, PEREZ J, ESTELA J, MAÑOS M, LOZANO L, SOLE R, MARTÍNEZ - LA CASA J, CASADO A

IAS Conf HIV Pathog Treat 2001 Jul 8-11;1st: Abstract No. 28

[ABSTRACT:] Background: Nonnucleoside reverse transcriptase inhibitors are now widely used as part of a first choice HAART regimen, but data about their anti-HIV-1 activity in reservoirs and its comparison with protease inhibitors are scanty.

Methods: A substudy evaluating the virological response of two HAART combinations (CNf or CNr) in tonsillar lymphoid tissue (LT), cerebrospinal fluid (CSF) and semen was performed in voluntary pts participating in a randomized, open, multicenter trial (Combine study). HIV-1 RNA (viral load (VL)) was determined by PCR (plasma, semen and CSF) or bDNA (LT) techniques according to published protocols. It was programmed to obtain samples at months 0, 6 and 12 in pts who continued with the initially allocated regimen.

Results: VL was determined in LT in 14 pts (7 CNf, 7 CNr), in CSF in 17 pts (9 CNf, 8 CNr) and in semen in 18 pts (9 CNf, 9 CNr). Median baseline VL in LT was 7.24 (6.77-7.38) log 10 equivalents/gram, and in CSF 3.16 (2.29-4.21) log₁₀ copies/mL. In only 2 pts VL was determined in semen at baseline (81,860 and 1,902 copies/mL). In all the CSF (n=15 at 6 months and n=8 at 12 months) and semen (n=14 at 6 months and n=6 at 12 months) studied samples, less than 200 copies/mL were found during follow-up. Regarding LT samples, a reduction of at least 3.5 log₁₀ equivalents/gram was observed in each arm at 6 months (n=14) and at 12 months (n=8). Undetectable VL levels were observed in 2/14 pts at 6 months (1 in each arm) and in 3/8 at 12 months (1 CNf, 2 CNr). In 2 pts (1 in each arm) a rebound in VL was observed in LT at 12 months. while plasma VL was < 20 copies/mL. Three months later plasma VL remained < 20 copies/mL in one and rose to 43 copies/mL in the other.

Conclusions: Both CNf and CNr achieve a virological response in reservoirs. However, anti HIV-1 activity may be suboptimal in lymphoid tissue, at least in some pts. The long term clinical significance of a rebound in HIV-1 RNA in LT and not in plasma is unclear.

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