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Prescription HIV Drugs
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- Explain to interested patients that drug-drug interactions can adversely affect how a medication performs.
- Note that this study found that smoking tobacco or marijuana lowered blood levels of a major anti-HIV drug — but only in patients who abused another drug.
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
SAN FRANCISCO — Smoking and substance abuse don’t mix for HIV patients under treatment with atazanavir (Reyataz), a researcher said here.
Whether it’s tobacco or marijuana, combining the smoke with another substance is likely to lower blood levels of the drug, according to Fatai Fehintola, MD, currently at the University of Ibadan, in Ibadan, Nigeria.
The danger is that patients could find the HIV medication less effective than otherwise, Fehintola said at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy meeting.
“At face value, there could be a tendency for breakthrough of the virus,” said Fehintola, who — with colleagues — carried out the study at the University of Buffalo in N.Y.
On the other hand, in a short, six-month study, there was no immediate effect on viral load in the affected patients, he said.
“Down the line, there may be something,” he said. “But in this short period, there was no direct effect.”
Use of anti-HIV drugs has a clear benefit for patients, he said, but “the need to maintain adequate blood concentrations of the various drugs remains a vital component of treatment.”
Fehintola and colleagues hypothesized that concentrations of atazanavir might be affected by substance abuse, so they compared 32 HIV-positive people with a substance-related disorder with 35 who did not have such a condition.
All had been on atazanavir-containing therapy for more than two years, he said.
At each of three clinic visits, the volunteers had blood tests for drug concentrations and for viral loads and CD4 cell counts.
The researchers found that 49% of the volunteers smoked tobacco, while 28% used alcohol, 10% cocaine, 18% marijuana, and 19% opioids. Nearly half — 43% — of patients abused multiple substances.
Analysis found that a large proportion of patients with substance-related disorders — those who smoked — had trough levels of atazanavir that were below the therapeutic range.
Specifically, tobacco smokers with a substance-related disorder had a trough level, on average, of 0.314 micrograms of atazanavir per milliliter of serum, compared with 0.957 for smokers who did not have such a disorder.
The difference was significant at P=0.009.
Similarly, marijuana smokers with a substance-related disorder had a trough level, on average, of 0.238 micrograms of atazanavir per milliliter of serum, compared with 0.593 for smokers without such a disorder.
The difference was significant at P=0.03.
On the other hand, there was no significant difference between the groups with and without a substance-related disorder when they were stratified by alcohol, cocaine, or opioid use, the researchers found.
There were also no differences in viral load or CD4 cell count between the groups with and without a substance-related disorder, they said.
The study “highlights the fact that things people do every day may have drug-drug interactions,” said Scott Hammer, MD, of Columbia University in New York. Hammer, one of the meeting’s program co-chairs, was not part of the research.
Clinicians have to be “on the alert,” he said, and patients need to check before using any substance they haven’t cleared with their doctors. “We can be fooled by drug interactions that we’re not prepared for,” Hammer said.
He added that substance-using populations “need to be taken care of with as much force and care as non-substance using populations,” he said.
The study had support from the National Institute on Drug Abuse.
The researchers did not report any conflicts.
Primary source: Interscience Conference on Antimicrobial Agents and Chemotherapy
Source reference:
Ma Q, et al “Tobacco and marijuana uses significantly decrease atazanavir (ATV) trough concentrations in HIV-infected individuals” ICAAC 2009; Abstract H-231.
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FDA Panel Supports HIV Drug for Treatment-Naive Patients
July 07th, 2010
WASHINGTON — An FDA advisory panel has recommended that the agency approve the antiretroviral HIV drug maraviroc (Selzentry) for treatment-naive patients.
The 10-4 vote by the Antiviral Products Advisory Committee would expand the use of the drug, which attacks the CCR5-tropic strain of HIV-1, beyond its current use among patients who have taken other antiretrovirals but have developed resistance to the drugs.
According to Pfizer, the manufacturer, treatment-naive patients are “arguably the most appropriate patient population” in which to use CCR5 antagonists because many of them are infected with the CCR5-tropic virus only.
The advisory panel considered 48- and 96-week efficacy and safety data of patients taking maraviroc in combination with zidovudine/lamivudine (Combivir) compared with those taking efavirenz (Sustiva).
At 48 weeks, maraviroc was found to be as effective at reducing viral load as efavirenz at <400 copies/mL, but didn’t show noninferiority in the more stringent measure of <50 copies/mL.
These underwhelming trial results were presented at the International AIDS Society Meeting in 2007. But when researchers applied new, more sensitive analyses to the data, they found patients treated with maraviroc had comparable results to efavirenz in suppressing viral loads to undetectable levels (<50 copies/mL) at 48 weeks.
A total of 12 deaths were reported in the trial, split evenly between the two treatment arms.
In a briefing document released in advance of the hearing, Pfizer scientists said that while there are other good treatments for HIV patients, more are needed “to meet the needs of a heterogeneous patient population.”
The FDA does not have to follow the advice of its advisory committees but it usually does.
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