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Cellular HIV‐1 DNA quantitation in patients during simplification therapy with protease inhibitor‐sparing regimens
Author(s) -
Sarmati Loredana,
Parisi Saverio Giuseppe,
Nicastri Emanuele,
d'Ettorre Gabriella,
Andreoni Carolina,
Dori Luca,
Gatti Francesca,
Montano Marco,
Buonomini Anna Rita,
Boldrin Caterina,
Palù Giorgio,
Vullo Vincenzo,
Andreoni Massimo
Publication year - 2007
Publication title -
journal of medical virology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.782
H-Index - 121
eISSN - 1096-9071
pISSN - 0146-6615
DOI - 10.1002/jmv.20914
Subject(s) - regimen , medicine , viral load , reverse transcriptase inhibitor , gastroenterology , peripheral blood mononuclear cell , protease inhibitor (pharmacology) , prospective cohort study , adverse effect , virology , immunology , virus , antiretroviral therapy , biology , biochemistry , in vitro
Simplified regimens containing protease‐inhibitors (PI)‐sparing combinations were used in patients with virological suppression after prolonged highly active antiretroviral therapy. This study evaluated the total HIV‐1 DNA quantitation as a predictor of long‐term success for PI‐sparing simplified therapy. Sixty‐two patients were enrolled in a prospective non‐randomized cohort. All patients have been receiving a triple‐therapy regimen, two nucleoside reverse transcriptase inhibitors (NRTIs) plus one PI, for at least 9 months and were characterized by undetectable plasma HIV‐1 RNA levels (<50 cp/ml) for at least 6 months. Patients were changed to a simplified PI‐sparing regimen to overcome PI‐associated adverse effects. HIV‐DNA levels in peripheral blood mononuclear cells (PBMCs) were evaluated at baseline and at the end of follow‐up. Patients with proviral DNA levels below the median value (226 copies/10 6 PBMCs) had a significant higher CD4 cell count at nadir ( P = 0.003) and at enrolment ( P = 0.001) with respect to patients with HIV‐DNA levels above the median value. At month 18, 53 out of 62 (85%) patients on simplified regimen showed virological success, 4 (6.4%) patients experienced virological failure and 5 (8%) patients showed viral blip. At logistic regression analysis, HIV‐DNA levels below 226 copies/10 6 PBMCs at baseline were associated independently to a reduced risk of virological failure or viral blip during simplified therapy (OR 0.002, 95% CI 0.001–0.46, P = 0.025). The substitution of PI with NRTI or non‐NRTIs may represent an effective treatment option. Indeed, treatment failure or viral blip were experienced by 6% and 8% of the patients on simplified therapy, respectively. In addition, sustained suppression of the plasma viral load was significantly correlated with low levels of proviral DNA before treatment simplification. J. Med. Virol. 79:880–886, 2007. © 2007 Wiley‐Liss, Inc.