3rd International AIDS Society Conference on HIV Pathogenesis and Treatment Rio de Janeiro - July 24 - 27, 2005

COMPARATIVE DISEASE PROGRESSION OBSERVED IN NEWLY DIAGNOSED PATIENTS INFECTED WITH DRUG RESISTANT AND SUSCEPTIBLE HIV-1: NO SIGNS FOR INCREASED VIRULENCE

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. WeOaLB0101

Wensinq A.M.J.¹, Van de Vijver D.A.M.C.², Vercauteren J.³, Albert J.⁴, Bratt G.⁵, Clumeck N.⁶, Coughlan S.⁷, Grossman Z.⁸, Hatzakis A.⁹, Horban A.¹⁰, Jevtovic D.¹¹, Bruun Jørgensen L.¹², Kuecherer C.¹³, Lange J.¹⁴, Nielsen C.¹², Paraskevis D.⁹, Poggensee G.¹³, Puchhammer-Stöckl E.¹⁵, Schmit J.-C.¹⁶, Stanczak G.¹⁰, Stanojevic M.¹⁷, Vandamme A.-M.³, Boucher C.A.B.^2
1Department of Virology and Department of Internal Medicine, University Medical Center Utrecht, Utrecht, The Netherlands, ²Department of Virology, University Medical Center Utrecht, Utrecht, The Netherlands, ³Rega Institute, Katholieke Universiteit Leuven, Leuven, Belgium, ⁴Department of Virology, Swedish Institute for Infectious Disease Control, Solna, Sweden, ⁵Venhälsan Södersjukhuset, Stockholm, Sweden, ⁶St-Pierre University Hospital, Brussels, Belgium, ⁷National Virus Reference Laboratory, University College Dublin, Dublin, Ireland, ⁸Sheba Medical Center, TelHashomer, Israel, ⁹Athens University Medical School, Athens, Greece, ¹⁰Hospital for Infectious Diseases & AIDS Diagnosis and Therapy Center, Warsaw, Poland, ¹¹Institute for Infectious and Tropical Diseases, University of Belgrade School of Medicine, Belgrade, Serbia and Montenegro, ¹²Department of Virology, Statens Serum Institut, Copenhagen, Denmark, ¹³Robert Koch Institute, Berlin, Germany, ¹⁴International Antiviral Therapy Evaluation Center, Department of Internal Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands, ¹⁵University of Vienna, Vienna, Austria, ¹⁶Centre Hospitalier de Luxembourg, Luxembourg, Luxembourg, ¹⁷Virology Department, Institute of Microbiology and Immunology, University of Belgrade School of Medicine, Belgrade, Serbia and Montenegro

INTRODUCTION: Recently rapid progression of disease due to transmission of a potential highly virulent, drug-resistant HIV-variant was reported in a patient from New York, USA. To rule out the potential spread of highly virulent drug-resistant viruses in Europe we compared disease progression in prospectively followed newly diagnosed patients infected with drug-resistant or sensitive viruses.

METHODS: From a large prospective multi-centered cohort of 1415 patients diagnosed in 2003, we identified individuals with primary resistant viruses (R) and compared disease progression to a random selection of patients diagnosed with sensitive viruses (S). Resistance testing was performed using genotypic analysis. IAS-USA was used to identify primary resistance mutations. As endpoints of disease progress were used CD4 decline <200 cells/mm³, initiation of therapy, or occurrence of an AIDS defining event. Time to progression was compared using Cox proportional hazards analysis.

RESULTS: Disease progression was compared between 78 patients infected with R-virus and 77 individuals infected with S-virus. Median follow-up was 16 months in both groups. Baseline CD4 and HIV-RNA in R and S were respectively 359 and 365 cells/m³ (p=0.9) and 4.8 and 4.7 log₁₀ copies/ml (p=0.4). Multi-class resistance was identified in ten patients. At time of diagnosis, the endpoint was reached in 24 patients in R (31%) and 20 individuals in S (26%), OR=1.3 (95% confidence interval 0.6-2.6, p=0.5). During follow-up, 18 of 41 in R (44%) and 26 of 47 in S (55%) reached one of the endpoints during follow-up, hazard ratio = 0.7 (0.31.1, p=0.1).

CONCLUSIONS: In this systematic approach patients recently diagnosed with resistant viruses experienced a similar disease progression as patients infected with drug-sensitive viruses. Currently there are no indications that multi-drug HIV variants with increased virulence are circulating in Europe. Further follow up is needed to determine whether clinical response to therapy once initiated may affect disease outcome.

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