HTB

Antiretrovirals

Non-refrigerated ritonavir tablet approved in Europe and the US

FDA safety review of saquinavir (Invirase) and possible association with abnormal heart rhythms

FDA updates US label for darunavir (Prezista)

FDA safety announcement about ddI and non-cirrhotic portal hypertension

FDA label change for lopinavir/r (Kaletra)

FDA notice about drug interactions with etravirine (Intelence)

Once-daily darunavir/r monotherapy is suboptimal as initial regimen in treatment-naive people

GSK issues Dear Doctor letter in the US: fosamprenavir and cardiovascular risk

Recent ARVs and the blood/brain barrier: CSF drug concentrations of darunavir/r and raltegravir

Tibotec issues Dear Doctor letter in Europe concerning severe etravirine reactions: three case reports

GSK and Pfizer launch joint HIV collaboration

First results of new integrase compound: GSK1349572

Raltegravir in treatment-naive patients

Nevirapine vs atazanavir/ritonavir in treatment-naive patients: ARTEN study

Darunavir/r monotherapy studies

Maraviroc results similar to efavirenz when analysed using more sensitive tropism test

Maximal suppression achieved with three drugs: no additional virological impact of raltegravir intensification

CD4 responses after viral suppression for more than 7 years on HAART

Raltegravir approved in Europe for treatment-naive patients

50mg and 100mg ritonavir doses achieve similar levels of saquinavir in Thai patients

Etravirine (Intelence) label change in the US due to severe hypersensitivity reactions

Four weeks lopinavir/r to cover functional monotherapy when stopping HAART

Efavirenz-related studies: genetics, smoking and TDM

Atazanavir: a suitable case for TDM?

Raltegravir approved in the US for treatment-naive patients: paranoia and anxiety added as side effects

EMEA positive opinion on using tipranavir and darunavir in younger patients

Lopinavir/r (Kaletra) cardiovascular risk requires FDA label changes

NEJM paper: NA-ACCORD cohort study on when to start treatment

NA ACCORD results support the importance of the START study: response to researchers

EMEA statement on abacavir and the risk of heart attack

Increased atazanavir dose recommended when used in combination with efavirenz or Atripla in naive patients

Summary of antiretroviral studies at Glasgow

EMEA approves once-daily darunavir/ritonavir (800mg/100mg) for treatment-naive patients in Europe

Maraviroc safety label changes included with US traditional approval

US approval of paediatric abacavir

EMEA supports extension of D:A:D study until at least 2012 and the new remit to include non-AIDS cancers and kidney disease

Applications to approve non-refrigerated ritonavir submitted to EMEA and FDA

Studies of pipeline drugs: RDEA806, PRO140, bevirimat, elvucitabine

Other antiretroviral studies at ICAAC

Non alcoholic fatty liver disease (NAFLD) is common among HIV-positive patients

FDA approves new paediatric AZT dosing

US revisions to darunavir label include once-daily indication for naive patients

Baseline renal insufficiency and mortality risk in HIV-positive adults in Zambia

Inflammatory and coagulation biomarkers linked to mortality in large treatment interruption trial

Abacavir and heart disease: SMART study supports an abacavir-associated increased risk of cardiovascular disease

EMEA state that animal studies support no increased risk of malignancy from contamination of nelfinavir (Viracept) with ethyl mesilate (EMS)

Antiretrovirals calculated to extend life expectancy by 35 years

Etravirine approved in Europe

Abacavir label updated in the US on use of B-5701 testing and cardiovascular risk

Ritonavir label updated in the US relating to cardiac arrhythmia reported in high-dose studies

Atazanavir label updated in the US relating to drug interactions with NNTRIs, hormonal contraceptives, midazolam, H2 receptor antagonists and other drugs

Pipeline antiretrovirals: IDX899, CHX157 and bevirimat

Renal tubular dysfunction with tenofovir-based HAART in four vertically infected adolescents

Boosted atazanavir approved in Europe as first-line therapy

BMS and Merck discontinue 100mg capsule formulation of efavirenz used for paediatric treatment

Saquinavir (Invirase) interactions with digoxin, garlic capsules, methadone, tipranavir and omeprazole: US label changes

US label changes for nevirapine paediatric solution

New US pediatric dosing for lopinavir/r

New US pediatric dosing for tipranavir/r

DSMB stops ACTG study due to suboptimal responses

Tibotec issue Dear Doctor letter and FDA require darunavir label change relating to hepatotoxicity

Atazanavir 300mg capsule available

Raltegravir approved in Scotland

Abacavir, ddI and risk of heart attack: additional published data and statements from the EMEA and FDA

Atazanavir/r vs lopinavir/r in treatment-naive patients: 48 week results

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