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Results from a recent Japanese study indicate that a Viread-based antiretroviral therapy regimen causes greater loss of kidney function than a Ziagen-containing therapy, particularly in people with HIV who weigh less than about 130 pounds.

Based on the results, the study authors recommended that people with HIV who are taking Viread, Truvada, or Atripla (which both contain Viread) and have a low body weight be monitored for loss of kidney function at least twice per year, particularly during their first year of treatment.

The researchers also noted that further research…

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Results from a small European study have shown that a short course of omega-3 fatty acids significantly lowers triglyceride levels in people experiencing high triglyceride levels during antiretroviral therapy for HIV.

“Triglycerides are frequently raised, have health implications, and are easily managed with measures that can include a safe supplement such as Omacor/Lovaza (omega-3 acid ethyl esters),” said Dr. Barry Peters, head of the Academic Unit of HIV and STDs at King’s College London and lead author of the study.

According to Dr. Peters and his colleagues, the study results…

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This article is the second of a two-part series on a review of Reyataz-related treatments and side effects. The first part discusses recent results on simplified Reyataz-based antiretroviral regimens; the second part discusses side effects associated with Reyataz.

A review of results from several studies on Reyataz indicates that relative to other antiretrovirals, Reyataz may be associated with fewer side effects in certain areas – such as heart problems – but more in other areas, such as kidney problems.

Results also showed that Reyataz alone was able to control…

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Norvir Prescribing Information Updated To Include Risk Of Life-Threatening Skin Condition – The U.S. Food and Drug Administration (FDA) has approved updated prescribing information for Norvir (ritonavir) to warn of the possibility of toxic epidermal necrolysis, a rare, life-threatening reaction to medications in which the top layer of skin detaches from the bottom layer and dies. The new prescribing information also notes that when Norvir is taken with the cancer drugs Tasigna (nilotinib) or Sprycel (dasatinib), used to treat certain forms of leukemia, or the painkiller fentanyl (Duragesic, Actiq), dose adjustments of these drugs may be necessary. For more information, please see the FDA press release.

Gilead Sciences And Janssen Therapeutics Agree To Lower AIDS Drug Prices For ADAPs – Gilead Sciences and Janssen Therapeutics (a division of Johnson & Johnson) have reached agreements with the ADAP Crisis Task Force (ACTF) to further reduce the prices for antiretrovirals purchased by state AIDS Drug Assistance Programs (ADAPs), which provide free antiretrovirals to low-income people with HIV. Due to state budget crises and an increase in the number of people requesting assistance, many states have tightened eligibility requirements or implemented waiting lists for ADAPs. According to ACTF, there were 6,595 people on ADAP waiting lists nationwide as of November 17. For more information, please see the press releases from ACTF (pdf) and the AIDS Healthcare Foundation.

GeoVax Begins Phase 1/2 Trial Of Therapeutic AIDS Vaccine; Still Recruiting Participants – Biotechnology company GeoVax Labs announced today that the first patient has received a dose of its investigational therapeutic HIV vaccine as part of a Phase 1/2 trial. The company is testing the safety and efficacy of the vaccine in controlling HIV replication in people already infected with the virus; participants will stop taking antiretrovirals for 12 weeks as part of the trial. The company also noted that it is still recruiting participants for the trial. Eligible participants must be HIV-positive and have started antiretrovirals within 18 months of their last negative HIV test; or have had a negative HIV test within the past 18 months and not yet started antiretrovirals. For more information, please see the GeoVax press release (pdf) or the U.S. Clinical Trials Registry.

Governors Push For Legalization Of Medical Marijuana – The governors of Rhode Island and Washington states have petitioned the federal government to legalize use of marijuana for medicinal purposes. Both states have legalized medical marijuana, and the governors argue that the change in federal law is necessary so that state employees are not prosecuted for distributing the drug. The U.S. Justice Department had previously sent letters to state governments warning of prosecution if they continued to distribute medical marijuana (see related AIDS Beacon news). The federal Drug Enforcement Agency rejected a request to reclassify the drug as acceptable for medicinal use in June; however, the governors argued that the evidence used for that rejection is several years old and that the medical community has since changed its stance on marijuana. For more information, please see the article in the New York Times.

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Isentress Prescribing Information Updated To Warn Of Severe Rash – The U.S. Food and Drug Administration (FDA) recently announced that the prescribing information for Isentress (raltegravir) has been updated to include a warning about the risk of a severe, potentially life-threatening rash. According to the FDA, patients taking Isentress should immediately contact their physician if they develop a rash. Physicians should advise patients to immediately stop taking Isentress if they develop a rash and have one or more of the following symptoms: fever, a general feeling of illness, extreme tiredness, muscle or joint aches, blisters, mouth lesions, eye inflammation, facial swelling or swelling of the eyes, lips, or mouth, breathing difficulties, or signs of liver problems (such as yellowing of the skin or eyes or pain under the ribs). For more information, please see the FDA press release.

AIDS Patients Sue Ohio Department Of Health Over New ADAP Regulations – Three HIV-positive patients and advocates have sued the Ohio Department of Health over new restrictions to the state’s AIDS Drug Assistance Program (ADAP), which provides free antiretrovirals to low-income people with HIV. According to the lawsuit, Department of Health officials failed to follow state laws on adopting new regulations, making them illegal. The plaintiffs also argue that the regulations would arbitrarily deny treatment to people with HIV. The new regulations would allow the Department to tighten restrictions on patient income for ADAP eligibility; they also include medical guidelines to determine waitlist priority if a waitlist is needed. A judge granted an injunction last week delaying implementation of the new regulations until the lawsuit has been resolved. For more information, please see the article on the New England Cable News website or the AIDS Healthcare Foundation press release.

Vertex Pharmaceuticals To Initiate Phase 3 Trial Of 12-Week Hepatitis C Regimen – Vertex Pharmaceuticals, the developer of Incivek (telaprevir), announced last week that it will initiate a Phase 3 trial of a 12-week hepatitis C treatment regimen consisting of Incivek, peginterferon-alfa, ribavirin, and its investigational hepatitis C virus polymerase inhibitor VX-222. The trial will test the regimen in both previously untreated and relapsed hepatitis C patients. The announcement of the new trial is based on results from a Phase 2 clinical trial that showed that 93 percent of patients treated with the four-drug regimen were cured of hepatitis C after 12 weeks. For more information, please see the Vertex Pharmaceuticals press release.

Bristol-Myers Squibb Investigates 12-Week, Interferon-Free Hepatitis C Treatment Regimen – Bristol-Myers Squibb is also independently investigating a 12-week, interferon-free treatment regimen for the treatment of hepatitis C. Bristol-Myers Squibb announced that it is adding the new 12-week treatment protocol to an existing Phase 2 clinical trial that is testing the same regimen as a 24-week treatment program. Patients will receive the investigational polymerase inhibitor PSI-7977 (developed by Pharmasett) plus Bristol-Myers Squibb’s investigational NS5A replication complex inhibitor daclatasvir (BMS-790052). Some patients will also receive ribavirin. The trial will test the regimens in both previously untreated patients and patients who have failed treatment with Incivek or Victrelis. For more information, please see the Bristol-Myers Squibb press release.