- U.S. guidelines updated
- Prezista news
- New Isentress study
- Videx-EC in children
- A case of transmission with undetectable virus
- Family fear of HIV
- Family fear of disclosure
- Syphilis and oral sex
- Discount on GSK meds
- Long-term couples survey
The U.S. HIV treatment guidelines for adults and adolescents were updated on November 3, 2008. The guidelines are written by a panel of experts, including advocates of people with HIV, through the Department of Health and Human Services (DHHS).
After finally reaching the “preferred” level for treatment of people taking HIV medications for the first time, the dual-drug Epzicom rode its wave of “success” for a very short time—until the next guidelines update. On November 3, Epzicom was downgraded to the “alternative” list of drugs. The popular Prezista/r (darunavir boosted with a small dose of Norvir, generic name ritonavir—hence the “/r”) was moved on to the preferred list for first-time protease inhibitors. Kaletra once-a-day was added to the preferred list (except for pregnant women), instead of just twice a day as before on this list.
According to an update from the U.S. Food and Drug Administration (FDA), “Abacavir + lamivudine [Epzicom] has been moved from a preferred to an alternative dual-NRTI component because of concerns regarding an increased risk of myocardial infarction [MI, or heart attack] in patients with high cardiac risk factors, as suggested by large observational cohort studies, and concerns regarding virologic potency in patients with baseline viral loads greater than 100,000 copies/mL.”
After discussing new efficacy data on Epzicom (it did not work as well as competitor Truvada in people with more than 100,000 viral load in a large independent study, but worked as well as Truvada in a smaller study sponsored by Epzicom’s manufacturer; see more on page 21), the guidelines state, “Concern has also been raised regarding the potential cardiovascular risks of abacavir-containing regimens [Trizivir, Ziagen and Epzicom]. The D:A:D study group reported an analysis of myocardial infarction (MI) risk in a large, multinational, observational cohort that involved 33,345 participants and had 157,912 person-years of follow-up. Recent (within 6 months) or current, but not cumulative [total] or past use (last use more than 6 months ago) of abacavir predicted an increased risk of MI (relative risk [RR], 1.9; 95% CI, 1.5-2.6).” That’s nearly double the risk for heart attack. The guidelines immediately went on to say, however, that “The heightened risk of MI with recent abacavir exposure was accentuated in participants who had pre-existing cardiac risk factors.
“A second study also suggested an increased risk of MI associated with abacavir. An analysis of 2,752 participants in the continuous treatment arm of the SMART study indicated that abacavir use was associated with an increased risk of MI when compared with other NRTI [medications in the same drug class as abacavir] use (RR, 4.3; 95% CI, 1.4-13.0).” Again, the guidelines then explain that pre-existing risk factors are involved: “Risk was concentrated in individuals with five or more known cardiovascular risk factors.
“In contrast to these two studies that suggested an increased MI risk among abacavir users, Cutrell et al [research sponsored by abacavir’s manufacturer] found no increased MI risk in a pooled analysis of 54 clinical trials, which involved 9,639 abacavir recipients, compared with 5,044 participants who received regimens without abacavir (RR, 0.9; 95% CI, 0.4-1.9).
“Although conflicting data exist regarding abacavir-based regimens, the combination of abacavir/lamivudine is now considered to be an alternative, rather than a preferred, dual-NRTI option. Pending additional data, abacavir/lamivudine should be used with caution in individuals who have plasma HIV RNA [viral load] greater than 100,000 copies/mL, as well as in persons at higher risk for cardiovascular disease.”
There were more updates to the guidelines, such as a discussion on simplifying therapy for treatment-experienced people. Pediatric and perinatal HIV guidelines were also updated. See all of the guidelines at www.aidsinfo.nih.gov.
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Prezista 300 mg tablets are being phased out in favor of a new 600 mg tablet. The Prezista dose is 600 mg twice a day, and must be taken with a small booster dose of Norvir.
Prezista also received full FDA approval late last year. Generally, new HIV drugs receive accelerated approval, a process pushed by advocates in order to bring badly needed meds to market as soon as possible. The manufacturer then has to complete the clinical study in order to receive full (traditional) approval. Prezista was also approved for people taking HIV medication for the first time. Newer drugs like Prezista, which was approved in 2006, are tested in treatment-experienced people, those who need a new drug the most.
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The extremely popular new drug Isentress (raltegravir) is being studied at a once-daily dose. Currently Isentress must be taken twice a day. It is being studied in combination with Truvada. Anyone interested in participating in this study should consult their doctor. For more information, visit www.benchmrk.com and click on QDMRK.
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The FDA expanded the use of Videx-EC to children weighing at least 20 kg (44 pounds). See the Dosage and Administration section of the drug.
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A case of transmission with undetectable virus
From the November 2008 AIDS Clinical Care newsletter for medical providers: “The documented transmission of HIV from a nonviremic patient to his partner makes a strong case for patients on successful ART to continue safer-sex practices.
“Earlier this year, the Swiss National AIDS Commission issued a statement suggesting that the risk for sexual HIV transmission in serodiscordant couples is negligible—and that condoms are no longer needed—if the infected person is on stable suppressive antiretroviral therapy (ART) and does not have other sexually transmitted diseases (STDs). The appropriateness of this statement was hotly debated at the International AIDS Conference in Mexico, with many expressing concerns about safety. A new case report from Germany lends credence to those concerns.
“The case involved a 30-year-old HIV-infected man who started ART in 2000 with AZT/3TC [Combivir] and efavirenz [Sustiva]. His plasma viral load declined to less than 50 copies/mL within four months and remained undetectable for at least the next four years. During this time, he reported good adherence to ART, and the treating physician confirmed the absence of other STDs. In 2002, the patient’s male partner of two years tested negative for HIV infection. In May 2003, the couple became less vigilant about safer-sex practices and began having unprotected anal intercourse. In July 2004, the partner seroconverted. Phylogenetic analysis ruled out the possibility that the partner had acquired the infection from a third person.
“Comment: This report demonstrates that sexual transmission of HIV can occur in a serodiscordant couple, even when the initially infected partner has undetectable plasma viral loads, no others STDs, and good adherence to an antiretroviral regimen known to penetrate the genital compartment. Although compelling data demonstrate a relation between low plasma viral load and reduced risk for HIV transmission, one cannot reasonably conclude from these data that persons with undetectable viral loads pose no risk for HIV transmission. A small but real risk remains, making the promotion of safer-sex practices essential, regardless of viral load.—Salim S. Abdool Karim, M.D., Ph.D. Case report from Antivir Ther 2008; 13:729. Stümer M. et al.
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A study by the University of California Los Angeles and other research partners (including Children’s Hospital Boston) found that two-thirds of families with an HIV-positive parent experience fears about spreading HIV in the home. According to a press release, “The qualitative study is the first to interview multiple family members, including minor children, in families with an HIV-infected parent about their concerns over HIV transmission in the household. The findings will be published in the November issue of the peer-reviewed journal, Pediatrics.”
“We found that many of the worries were based on misconceptions about how HIV is spread,” said lead study author Burt Cowgill in the release. He is a staff researcher at the UCLA/RAND Center for Adolescent Health Promotion. “We also learned that HIV-infected parents had legitimate concerns about contracting infections such as a cold, flu, or chicken pox while caring for a sick child. This knowledge could help pediatricians to address children’s specific fears about HIV transmission as well as help clinicians who care for the HIV-infected parents.”
The researchers conducted interviews with 33 HIV-positive parents, 27 of their minor children (ages 9 to 17), 19 adult children, and 15 caregivers (spouses, partners, grandparents, or friends). They reported that although the families provided education on HIV, some fears were based on incorrect information and beliefs. Read the entire press release online.
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Writing from London for the November 2008 HIV Treatment Update, Edwin J. Bernard reports on the Don’t Forget the Children conference that recently took place in that city. Topics included untested children of positive mothers and the issue of children infected at birth who are not diagnosed or treated until they are adolescents. “When [Dr. Michael Eisenhut] asked the mothers why they had not tested their children, the most common response was the belief that because the child appeared to be well, it could not be infected. Other reasons included feeling unable to cope with a child’s positive diagnosis; a fear of confronting the child with the mother’s own HIV diagnosis; and a fear of feeling guilty if a child turned out to be HIV-positive.” See the report at www.aidsmap.com. The conference website is www.chiva.org.uk/news/dontforget.html.
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The U.S. Centers for Disease Control and Prevention (CDC) is promoting education around syphilis in the gay community and large metropolitan areas. “A lot of my patients think they’re doing fine because they use condoms, but they don’t know they can get syphilis through oral sex,” said Los Angeles HIV specialist David Hardy, M.D. “Syphilis transmits very easily through oral sex. And it’s a very quiet disease.” Positively Aware asked Hardy at a recent conference what he thought the magazine should cover that would be helpful to his patients. This information is what he wants everyone to know.
According to the “Get Tested, Chicago” campaign, a collaboration between the city’s Department of Health and the CDC, signs of syphilis include:
- Sores or white patches on the genitals, anus, or mouth
- Rashes on palms of both hands or on bottoms of both feet
- Rash on any other part of the body
- Unexplained hair loss
“Don’t be fooled,” warns the campaign. “Syphilis often has no symptoms. Syphilis stays in your body even if sores go away. Only regular testing ensures your health.” The campaign recommends that people with multiple sex partners test for syphilis every six months. Visit www.GetTestedChicago.com or call 1-800-243-2437.
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GlaxoSmithKline (GSK), maker of several drugs used to fight HIV, recently announced the launch of a new Patient Savings Card designed to help improve compliance among eligible participants by reducing their out-of-pocket expenses for GSK HIV medications. Through this program, patients are eligible to save up to $100 each month—for each of their GSK HIV medicines—for up to two years following their first use of the card. Patients can enroll in the program by visiting their doctor and asking about it. According to a GSK press release, “GSK has worked closely with leaders in the HIV community, the Fair Pricing Coalition among these, to improve access to HIV medicines since the beginning of the epidemic. Recently the community has voiced a significant need among those patients in the non-government program segment, who may find paying their out-of-pocket costs an increasing challenge to adhering to their drug regimen.” Eligible individuals include patients who are paying out-of pocket costs and whose prescriptions are not covered by Medicaid, Medicare, ADAP, or any other Federal or State assistance program. The medications are zidovudine (brand name Retrovir); Epivir; Combivir; Ziagen; Epzicom; Trizivir; and Lexiva. Some restrictions may apply, and more information about the program is available at www.mysupportcard.com. Read the entire press release online.
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From friends of TPAN: “A long-term couple (30-plus years) is conducting research on how other long-term gay, male couples manage ‘outside’ sex, to see if there are any common elements and successful models that would be valuable to share with other couples. The study will look at how couples who have been together for eight or more years have navigated this issue, what ‘rules’ they find helpful, and the impact ‘outside’ sex has on their relationship.
“Interviews are conducted separately with each partner, and all information is considered confidential, including not sharing one partner’s responses with the other. Some demographic data will be collected such as age, race, and HIV status, but participants will be asked to provide only the information they are comfortable sharing, and may choose to use a pseudonym.
“Participants will be notified by e-mail at completion of the project and sent a report of the findings. Findings from the study will be shared with the LGBT community.
“For each couple participating, a donation of $50 will be made to the LGBT or HIV/AIDS organization of their choice. For more information contact Lanz Lowen at lanzlowen@aol.com or Blake Spears at dbspears@aol.com.”
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