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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
1 hour 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
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 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
Lipodystrophy
Mark S. King: I'm Gonna Wipe That AIDS Right Off My Face

It was all well and good to be front and center as an HIV-positive man during the first years of the AIDS crisis. It's easier being a role model when your face looks good on the poster. But then, slowly but surely, a common side effect of HIV medications, facial wasting, began to appear.

Published
30 January 2013
From
Huffington Post
Neurological and cognitive problems
Neuropathy and HIV: A Progress Report

Neuropathy affects up to 40% of all people with HIV, yet the treatment has remained more or less the same for decades. Prescribing drugs meant for other diseases, has led to haphazard results; time for a change - but is it happening?

Published
11 January 2013
From
PositiveLite
Side-effects
FDA clears Salix anti-diarrhoeal for HIV patients

The US Food and Drug Administration has approved the first anti-diarrhoeal drug specifically for people with HIV, Salix Pharmaceuticals Ltd.'s Fulyzaq. The drug, also known as crofelemer, is meant to relieve symptoms of noninfectious diarrhoea in people with HIV on antiretroviral therapy. Fulyzaq is derived from the red sap of the Croton lechleri plant and is the second botanical prescription drug approved by the FDA. However, although crofelemer produced a 55% reduction in watery diarrhoea in people with HIV on ART who chronically suffered from it, this only means that 17.6% of patients improved during the study period rather than 8% given a placebo.

Published
02 January 2013
From
MarketWatch
Cardiovascular disease
HIV11: Lipid Levels Are Higher among HIV+ People on ART, Immune Suppression May Play a Role

People with HIV on suppressive antiretroviral therapy (ART) have "considerably higher" blood lipid levels relative to untreated individuals or those on less effective treatment, researchers reported at the 11th International Congress on Drug Therapy in HIV Infection (HIV11) last month in Glasgow. They also found that greater immune deficiency, as indicated by lowest-ever CD4 count, was associated with lipid elevations.

Published
17 December 2012
From
HIVandhepatitis.com
Side-effects
Liver toxicity uncommon with modern antiretroviral drugs, but higher risk for HIV/HCV coinfected

Recently approved antiretroviral drugs are generally well-tolerated and seldom cause serious liver enzyme elevations, although protease inhibitors are somewhat more likely to do so, researchers reported in the November 28, 2012, advance online edition of AIDS. People with HIV/HCV coinfection are more likely to experience liver toxicity, however.

Published
06 December 2012
From
HIVandHepatitis.com
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