by Enid Vázquez
- Isentress update
- Reducing Sustiva side effects
- Prezista update
- Aptivus update
- Videx update
- Oral sex and HIV
- Puerto Rico and HIV
- Women’s conference in New York City
- PrEP—will young men take it? And
will it be practical?
- New black community initiative
—“Greater Than AIDS”
In July, the U.S. Food and Drug Administration (FDA) expanded the approval of Isentress (raltegravir) to include people using HIV medications for the first time. Like other HIV drugs approved over the past several years, Isentress was approved for use by people who were previously on antiviral treatment and whose therapy was failing. Isentress is the only medication in its drug class, integrase inhibitors, currently on the market and is extremely popular for its effectiveness as well as its low rate of side effects. As such, it was already being used for people taking HIV therapy for the first time, under off-label use.
New interaction information was also added to the new drug label. Isentress was found to have no significant clinical interactions with methadone.
In addition, two new side effects were added to the label, based on treatment experience after Isentress was approved: paranoia and anxiety. Neither the severity nor the percentage of people experiencing these effects, however, was provided.
Spanish researchers found that starting treatment with a lower dose of the HIV drug Sustiva (efavirenz) and increasing it to full dose over a period of two weeks helps reduce the number and severity of side effects with the drug. Sustiva is very effective and widely prescribed, but is associated with a long list of central nervous system (CNS) or psychiatric side effects, including insomnia, vivid dreams, and thoughts of suicide. Some people experience the side effects for years, and people with a history of street drug use may be at greater risk of these symptoms. Using a stepped-up dose in first-time patients has been found to reduce side effects of other medications, including other HIV antivirals. The small study was published in the August 4 issue of Annals of Internal Medicine.
Half of the 144 study participants received the stepped-up dose of 200 mg for six days, then 400 mg for seven days, then the full dose of 600 mg (all once a day). The other half received the full daily dose. After 24 weeks, viral load reductions were the same for both groups, while side effects were reported to be less in the stepped-up dose group. In the future, this study might influence the Sustiva dose in people taking it for the first time, but not that of individuals already on the medication.
In June, the FDA changed the drug label of the HIV protease inhibitor Prezista (darunavir) to state that no dosing adjustment is required when taking it with buprenorphine (Subutex) or buprenorphine/naloxone (Suboxone), but clinical monitoring is recommended. Subutex and Suboxone are used for the treatment of opioid (such as heroin and morphine) addiction.
The FDA in June updated the Aptivus (tipranavir) drug label. Aptivus is an HIV protease inhibitor medication. It must be taken with a low dose of the HIV drug Norvir (ritonavir). The lowest levels of Aptivus (trough concentration) were 45% higher than normal in people taking it along with the HIV drug Fuzeon (enfuvirtide). This update comes from Phase 3 (advanced) studies. Dose adjustments, however, are not recommended. Calcium channel blockers, which are used for a variety of heart-related conditions (such as angina and high blood pressure), should be used with caution when taking Aptivus/Norvir and patients should be monitored. In addition, blood levels of Aptivus were decreased 40% when taken with buprenorphine/naloxone (Suboxone), but dose adjustments are not recommended. The effectiveness of Suboxone is not affected.
In June, the FDA updated the drug label on the HIV medication Videx (didanosine) pediatric powder and Videx EC capsules. The FDA removed the dose adjustments for adverse events such as pancreatitis and peripheral neuropathy, stating that dose reductions for Videx other than for weight have not been established.
Also, two contraindications (drugs not to be taken together) were added. Videx should not be taken with ribavirin, a drug used to treat hepatitis C. The FDA reported that, “Fatal liver failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis have been reported in patients receiving both didanosine and ribavirin. Previously, the combination of didanosine and ribavirin was ‘not recommended’ due to serious adverse events including fatal hepatic failure.”
Videx should also not be taken with allopurinol (brand name Zyloprim), a medication used to reduce uric acid, excess amounts of which can lead to gout or kidney stones. In good news, hyperuricemia (excess uric acid) was removed from the list of possible side effects, because very few cases of gout were seen.
Ganciclovir was not recommended with Videx, but the label update states that if no suitable alternative to ganciclovir is available, it may be used with caution and with monitoring for Videx toxicity. When taken with ganciclovir, Videx blood levels increase.
Videx pediatric powder should not be taken with methadone, but if taking the two medications is necessary, the Videx EC formulation should be used and there should be close monitoring for didanosine effectiveness, including viral load. (Note: Adults may use a pediatric formula for various reasons.) Methadone lowers the blood concentrations of Videx.
Last, a dosing recommendation was added for another HIV drug, Viracept (nelfinavir). Viracept should be taken one hour after taking Videx EC.
The CDC (U.S. Centers for Disease Control and Prevention) in June updated its factsheet on oral sex and HIV. The following words were added: “numerous studies have demonstrated that oral sex can result in the transmission of HIV and other sexually transmitted diseases (STDs).” For a copy, write to CDC, 1600 Clifton Road, Atlanta, GA 30333, call 1-800-342-AIDS (342-2437), or visit www.cdc.gov.
The June 6 issue of the CDC’s Morbidity and Mortality Weekly Report provided a look at HIV on the island of Puerto Rico. According to an editorial note accompanying the report, “[The] estimates of HIV incidence in Puerto Rico in 2006 reveal important differences between HIV epidemiology in Puerto Rico and the 50 U.S. states and the District of Columbia. The overall HIV incidence rate in Puerto Rico in 2006 (45.0 per 100,000 population) was twice the estimated U.S. rate (22.8) and 1.5 times the estimated rate for Hispanics in the United States (29.4). … Injection drug use continues to be the most common mode of HIV transmission in Puerto Rico, whereas most new HIV infections in the 50 U.S. states and the District of Columbia are attributed to male-to-male sexual contact.” See contact information above to obtain a copy.
Pharmaceutical company Boehringer-Ingelheim (BI), maker of the HIV drugs Viramune (nevirapine) and Aptivus (tipranavir), in partnership with Iris House and other community organizations, is holding a free one-day women’s event on HIV in New York City on Friday, September 25. “Women Living Positively: It’s My Life, National Women’s Summit” is scheduled from 9 a.m. to 2 p.m. at the Gay Men’s Health Crisis (GMHC) Women’s Institute, 119 West 24th Street. Breakfast and lunch will be provided. Women interested in attending the summit should call toll-free at 1-877-933-4310, extension 99517, as soon as possible to reserve a seat. Simply leave a first name, there will be no call-backs for confirmation.
BI videotaped one of its previous women’s summits, held in Florida. Due to issues of confidentiality, question-and-answer sessions and breakout groups were not taped. The video can be seen at www.vodium.com/goto/womenlivingpositive.asp
The outstanding speakers shown on the video include Dr. Ana Puga, Director of the Comprehensive Family AIDS Program of the Children’s Diagnostic and Treatment Center in Fort Lauderdale; the Rev. Makeba D’Abreu, Director of the Domestic HIV Programs for The Balm in Gilead in Richmond, Virginia, and Andrea Williams, who talks about her inadvertent claim to fame when her brother helped bring about the HBO movie Life Support based on her story, starring Queen Latifah.
Williams will speak at the New York City event, along with Michelle Lopez, a long-time survivor of HIV (visit www.POZ.com and www.thebody.com); Dr. Nereida Ferran of the Jacobi Medical Center; and fitness expert and inspirational speaker Valerie Wojciechowicz, who has lived with HIV for more than 20 years.
Former Positively Aware associate editor Keith R. Green is now heading up a research study called Project PrEPare, developed at Stroger Hospital here in Chicago, which focuses on HIV prevention among young men of color.
The study is part of ongoing efforts to see if using medication before sexual encounters can prevent HIV infection. At this point, however, Project PrEPare isn’t looking at efficacy, but rather to see if the strategy is acceptable to young men who have sex with men (YMSM), gay or not, and whether it’s practical.
A risk reduction program called “Many Men, Many Voices” is part of the study, as well as other strategies to help the young men protect themselves from HIV infection. Compensation will also be provided.
The medication being given is Truvada, which has been used in other studies looking at HIV prevention, mostly because of its efficacy and low side effect profile.
To find out more or to become a member of the study, call 312-864-8003 or e-mail firstname.lastname@example.org. The study is also taking place in Chicago at the CORE Center (call 312-572-4500) and Howard Brown Health Center (call 773-388-1600). Project PrEPare is being conducted through the Adolescent Trials Network for HIV/AIDS Intervention (ATN for short).
From Positively Aware e-update
On June 25, the Kaiser Family Foundation, in conjunction with the Black AIDS Media Partnership (BAMP), announced the creation of “Greater Than AIDS,” a nationwide campaign that seeks to address HIV/AIDS in the black community. The new campaign is being produced in collaboration with the CDC’s “Act Against AIDS” initiative. BAMP, a coalition of leading black media companies, is developing and distributing the various messages that will reach the black community through public service announcements, integrated media content, and community outreach. Community organizations are invited to join the initiative; visit www.kff.org. Also visit