The 12th Annual HIV Drug Guide from Positively Aware is now available
This invaluable resource includes tons of useful information, including tips on how to use...

Is Epzicom as effective for people with high viral loads, ACTG study asks?
A study being conducted by the AIDS Clinical Trials Group (ACTG) examines the...

Selzentry shows potential for use in PEP
Health care workers and others who benefit from post-exposure prophylaxis (PEP)...

FDA approves 600 mg tablet of Prezista
The U.S. Food and Drug Administration (FDA) recently approved a new 600 mg tablet...

Policy that disqualifies HIV-positive people from entering Foreign Service changed by U.S. State Department
Last month, HIV was removed from a list of medical conditions that disqualify people...

Legislation that would require people convicted of intentionally spreading HIV to register as sex offenders approved by South Dakota House
Last month, the Associated Press reported that the South Dakota House of...

The 12th Annual HIV Drug Guide from Positively Aware is now available

This invaluable resource includes tons of useful information, including tips on how to use all of the currently approved HIV drugs, as well as doctor and activist comments, side effects and drug interaction charts, and much, much more.

E-mail us at distribution@tpan.com to receive your copy today. Or, to receive them in bulk for your agency or clinic, call Joe at (773) 989-9400 ext. 244.

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Is Epzicom as effective for people with high viral loads, ACTG study asks?

A study being conducted by the AIDS Clinical Trials Group (ACTG) examines the safety, tolerability and effectiveness of four different antiretroviral treatment regimens in HIV-infected adults who had never taken anti-HIV drugs before.

A preliminary analysis of ACTG study 5202 found that Epzicom (fixed-dose combination of Epivir and Ziagen) was not as effective as Truvada (fixed-dose combination of Viread and Emtriva) at decreasing viral load in patients who entered the study with a viral load higher than 100,000 copies per milliliter of blood when used in combination with either Sustiva or boosted Reyataz.

These findings are inconsistent with data from six previous studies conducted by GlaxoSmithKline (GSK), the maker of Epzicom, which showed a 94 percent reduction in viral load for patients enrolled with viral load greater than 100,000. In addition, GSK points out that recently reported data from the HEAT study (which directly compares Epzicom to Truvada combined with Kaletra) showed treatment with Epzicom reduced viral load to the target at 24 weeks in 94 percent of its patients.

GSK suggests that not excluding patients at risk for a known reaction with Epzicom, as well as not testing for baseline resistance to treatment, could be confounding factors which may contribute to the unexpected results of the ACTG study. The pharma giant does not believe that the interim results of this single, ongoing study warrant a change to clinical practice.

An independent data and safety monitoring board has recommended that the participants in the study with high viral loads consider switching from Epzicom to Truvada. The board did not find other significant safety concerns regarding the drug that warrant a recommendation for those with lower viral loads to switch regimens.

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Selzentry shows potential for use in PEP

Health care workers and others who benefit from post-exposure prophylaxis (PEP) following potential exposure to HIV may have another option available to them soon, Selzentry (maraviroc).

Selzentry was recently approved for use in treatment with people living with HIV. It is the first oral therapy available in a class of drugs known as entry inhibitors. Entry inhibitors attack HIV at its point of entry into the T-cell. They are used in combination with other anti-HIV drugs, from at least one of the four other classes, which attack HIV at different points of its lifecycle.

Though no clinical studies have been conducted to prove it, many anti-HIV drugs have been reported to be effective in PEP. PEP works by giving a potentially exposed individual an HIV regimen for 28 days in hopes of preventing infection. Efforts to date have found this strategy to be generally effective with minimal toxicity.

Selzentry was used in this way recently, when a health care worker in France was accidentally stuck with a needle that contained blood from a patient who was known to be HIV-positive.

The patient’s medical history was carefully examined, and he was found to be a carrier of highly resistant virus as a result of years of exposure to different anti-HIV drugs. The health care worker was immediately given a regimen similar to the one that the patient was on, and Selzentry was added the next day. Six months later, the health care worker was found to still be HIV-negative.

This is the first published case of Selzentry being successfully used in PEP. Clinical studies are necessary to determine the probability of this success being repeated in more potentially exposed individuals.

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FDA approves 600 mg tablet of Prezista

The U.S. Food and Drug Administration (FDA) recently approved a new 600 mg tablet strength of Prezista (darunavir).

Prezista, a relatively new drug from the class of anti-HIV drugs known as protease inhibitors, was approved for use with a recommended dose of 600 mg (two 300 mg tablets) taken twice daily taken with food and boosted with 100 mg of ritonavir.

The new 600 mg tablet, which is expected to be available in mid-May 2008, will reduce the pill burden of Prezista, which must be used in combination with other anti-HIV drugs to be effective.

The 300 mg tablet will still be available.

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Policy that disqualifies HIV-positive people from entering Foreign Service changed by U.S. State Department

Last month, HIV was removed from a list of medical conditions that disqualify people from entering the Foreign Service.

The U.S. State Department announced that candidates for Foreign Service who are living with HIV will now be considered on a case-by-case basis, in the same way that candidates who have other illnesses are screened to determine their eligibility for “worldwide availability.” This change comes partially in response to a lawsuit involving an HIV-positive man, Lorenzo Taylor, who despite his qualifications was rejected by the Foreign Service.

According to Gonzalo Gallagos, a state department spokesperson, the department’s chief medical office has “revised its medical clearance guidelines on HIV based on advances in HIV care and treatment and consultations with medical experts. The new clearance guidelines provide that HIV-positive individuals may be deemed worldwide available if certain medical conditions are met.” 

In a statement made following the settlement of his lawsuit, Taylor said, “Now people like me who apply to the Foreign Service will not have to go through what I did. They and others with HIV will know that they do not have to surrender to stigma, ignorance, fear or the efforts of anyone, even the federal government, to impose second-class citizenship on them. They can fight back.”

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Legislation that would require people convicted of intentionally spreading HIV to register as sex offenders approved by South Dakota House

Last month, the Associated Press reported that the South Dakota House of Representatives voted unanimously to approve legislation that would require people who have been convicted of intentionally spreading HIV to register as sex offenders, following their release from prison. The measure was approved by the Senate in January.

According to Sen. Sandy Jerstad (D), who sponsored the bill in the Senate, this legislation will provide the public with information about the possible dangers that people convicted of intentionally spreading HIV pose.

The maximum prison sentence for intentionally spreading HIV in South Dakota is 15 years. To date, there have been two convictions in that state.

The bill will now go before South Dakota Governor Mike Rounds (R) for consideration.

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