Unregistered User If this is not your name, click here.
		Contact Us | Order Now | Journals | Bookstore | Register a colleague
	Select a ChannelAcneAIDS and HIVAllergy OtherAlzheimer'sAnaesthesiology OtherAngina Pectoris/MIAnxietyArthritis OtherAsthmaBack PainBacterial InfectionsBladder CancerBone Marrow TransplantationBreast CancerCardiology OtherCataractCell TransplantationCervical CancerCholesterol/Lipid disordersCirrhosisClinical PharmacologyColorectal CancerCongestive Heart FailureContact DermatitisContraceptionCOPDCystic FibrosisDental and Oral DisordersDepressionDermatology OtherDiabetesDialysisEating DisordersElbowEmergency MedicineEndocrinology OtherEpilepsyErectile DysfunctionFibromyalgiaGastro OtherGeneticsGenitourinary OtherGeriatricsGERD/GastritisGlaucomaH. Pylori/UlcerHaematology OtherHair LossHeadachesHepa/Biliary OtherHepatitisHipHRTHypertensionIBDImmunologyInfectious OtherInfertilityIntensive CareIrritable Bowel SyndromeKneeLeukemiasLiver CancerLung CancerLupusLymphomasMelanomaMenopauseMultiple Sclerosis Nephrology OtherNeurologic OtherNutritional / Metabolic OtherOb/Gyn OtherObesityOncology OtherOphth. OtherOphthalmic SurgeryOrgan TransplantationOrthopaedics OtherOsteoarthritisOsteoporosisOtitisOtorhino. OtherOvarian CancerPaediatricsPainPancreatic CancerParkinson'sPregnancyProstate CancerPsychiatry OtherPulmonary OtherRadiologyRenal CancerRenal FailureRespiratory InfectionsRheumatoid arthritisRheumatology OtherRhinitisSchizophreniaShoulderSleep ApnoeaSleep DisordersSpineStrokeSTDsSurgeryThyroid DisordersTransfusionTransplant Surgery OtherTraumaUrinary IncontinenceUrinary tract infectionsVaccinologyVascular DisordersViral Infections

SEARCH   News Bookstore Medline The Web Meetings & Congresses Complete Doctor's Guide    EXPLORE :    All News   All Webcasts   All Cases   All Meetings & Congresses   All Medical Resources New drugs / indications English Dictionary Medical Dictionary Thesaurus Warning | Privacy | Awards  Favourite Journals  Click here to choose your favourite journals  Favourite Sites  Click here to choose your favourite sites  Languages  Select languageEnglishFrançais

CROI: Viramune Plus AZT And 3TC Effective For Patients With Very High HIV Levels SAN FRANCISCO, CA -- February 4, 2000 -- Results demonstrating the significant potency of Viramune® (nevirapine, NVP) were presented today at the 7th Conference on Retroviruses and Opportunistic Infections in San Francisco/USA. Findings show Viramune added to a combination of AZT and 3TC suppressed HIV in the blood for up to one year and longer in patients with advanced HIV disease and high baseline viral loads. The mean baseline viral load of these patients was very high -- 138,986 copies/mL of blood and the mean CD4+ count was only 101 cells/mm3. Study participants had not previously been treated with antiretrovirals. "Results presented today demonstrate that Viramune -- a drug most frequently studied in patients with low to moderate viral loads -- is effective in patients with advanced HIV infection and high viral loads," explained Dr. Richard Pollard of the University of Texas Medical Branch at Galveston, Texas, USA. "This study is unique because the patients studied had extremely high viral loads, some having more than a million copies of virus per milliliter of blood." The analysis presented today evaluated 171 antiretroviral-naive patients randomized to receive AZT and 3TC plus either Viramune or placebo (77 Viramune and 94 placebo) as part of a large, international study (BI 1090). About 25 percent of patients in the study had baseline viral loads greater than 500,000 copies/mL. Forty-five percent of patients taking the triple drug combination (Viramune +AZT+ 3TC) achieved suppression of HIV below the limit of detection at one year. This result was achieved using the most sensitive assay approved by the US Food and Drug Administration, which can detect virus in the blood as low as 50 copies/mL, and using a strict "intent-to-treat analysis." This type of analysis accounts for all patients, including those who stopped treatment before the end of the study. Additionally, a mean 137 CD4+ cell increase was seen in these patients. "These data show that Viramune +AZT+3TC can suppress HIV levels to below the limit of detection for more than one year and substantially increase CD4 counts," noted Dr. Pollard. "The efficacy of the Viramune regimen was independent of the baseline viral load." At 12 months, the percentage of Viramune patients with undetectable levels of HIV (<50 copies/mL) was similar in patients with baseline viral loads above the median, as compared to patients with baseline levels below the median (46 percent and 47 percent, respectively). Since this trial was conducted, the triple combination of Viramune +AZT+3TC has become available in a simple, twice-daily regimen (Viramune +Combivir) that requires a total of only four pills per day. There are no food or fluid restrictions associated with this combination. "We're pleased that this trial provided results that are relevant today. It's important to note that this study was designed in 1995 and was based on the standard of treating AIDS patients at that time," explained Dr. Pollard. "With significant advances in the HIV/AIDS treatment arena since the trial's inception, the dual-therapy comparator arm in this study is no longer considered standard of care. However, this study demonstrates that the Viramune triple therapy regimen is a very viable treatment option for patients today, regardless of patients' viral load." No safety information is available from the study presented today. However, Viramune is generally well-tolerated. The most clinically important adverse events associated with VIRAMUNE are rash and increases in liver function tests. Cases of hypersensitivity reactions have been observed. Severe and life-threatening skin reactions and hepatotoxicity, including fatal cases of each, have occurred in patients treated with Viramune. Viramune, the first member of the non-nucleoside reverse transcriptase inhibitor (NNRTI) class of anti-HIV/AIDS drugs to be approved, is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on analysis of changes in surrogate end-points, such as viral load or changes in CD4+ count. Viramune should always be administered in combination with other antiretroviral agents. Related links: AZT, Viramune and 3TC. E-mail this page to a friend or colleague! To print, use this version