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Side-effects
EU new drug approval studies "have too few patients to evaluate safety"

For medicines intended for chronic use, the number of patients studied before regulatory approval in the European Union (EU) is insufficient to properly evaluate safety and long-term efficacy, and this points to a need for new EU legislation, say researchers writing in this week's PLOS Medicine.

Published
2 hours ago
From
Pharma Times
Side-effects
Long-term efavirenz linked to worse neurocognitive function in US CHARTER group

Long-term treatment with an efavirenz-based regimen correlated with worse neurocognitive function than did treatment with lopinavir/ritonavir, according to results of a retrospective case-control comparison within the US CHARTER cohort.

Published
07 March 2013
From
EATG / NATAP
New and experimental HIV treatments
Dual CCR5/CCR2 inhibitor cenicriviroc has anti-inflammatory as well as anti-HIV effect

Cenicriviroc, which blocks both CCR5 and CCR2 receptors on immune cells, is effective against HIV, better tolerated than current antiretrovirals and has immunomodulatory activity that may reduce inflammation,

Published
06 March 2013
By
Liz Highleyman
Prevention of mother-to-child transmission
Small risk of neurological birth defects due to efavirenz confirmed in French cohort

A large French study has found an elevated risk of some birth defects in children born to women exposed to some antiretroviral drugs during the first trimester

Published
06 March 2013
By
Keith Alcorn
Side-effects
Intelence (etravirine) labeling updates

On February 27, 2013, FDA approved changes to the Intelence (etravirine) label to include revisions to the Warnings and Precautions, Adverse Reactions, and Postmarketing Experience sections to include information regarding drug rash with eosinophilia and systemic symptoms (DRESS), to update Adverse Reaction section with information regarding the occurrence of rash in men vs. women and pediatric patients and to add drug interaction information for artemether/lumefantrine and telaprevir

Published
02 March 2013
From
US Food and Drug Administration
Kidney problems
Tenofovir, atazanavir/ritonavir and Kaletra associated with kidney problems in patients taking HIV therapy

Data from a large study into the safety of anti-HIV drugs suggest that the antiretrovirals tenofovir (Viread, also in Truvada, Atripla and Eviplera), atazanavir (Reyataz) and lopinavir/ritonavir

Published
15 February 2013
By
Michael Carter
Kidney problems
Tenofovir May Raise Risk of Kidney Damage, but Effect Tapers Over Time

Tenofovir raises the risk of kidney dysfunction among people with HIV, but the adverse effect occurs mostly within the first two years of therapy.  

Published
14 February 2013
From
AIDSMeds
Side-effects
Recent changes to the Reyataz (atazanavir sulfate) capsule labeling

Recently FDA approved changes to the Reyataz (atazanavir sulfate) capsule labeling to include the following changes. Section 5 Warnings and Precautions was revised to include cholelithiasis as follows.

Published
11 February 2013
From
FDA
Prevention of mother-to-child transmission
Pregnancy does not increase risk of nevirapine side-effects

Pregnancy does not increase the risk of nevirapine (Viramune) associated side-effects, according to the results of a systematic review and meta-analysis published in the online edition of AIDS. Investigators

Published
07 February 2013
By
Michael Carter
Side-effects
Tenofovir impairs enzyme that stops cells ageing

A team of Australian researchers has found that tenofovir and, to a lesser extent, other drugs from the nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) class, impairs an enzyme that

Published
31 January 2013
By
Gus Cairns
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