POSITIVELY AWARE July/August 2012
The Quad goes before the FDA
An FDA advisory committee voted 13–1 to recommend that the FDA approve a new once-daily HIV drug known as the Quad. The FDA usually follows the recommendations of its advisory committee and is scheduled to consider approval of the Quad by August 27. If approved, it becomes the third single-tablet HIV regimen on the market, along with Atripla and Complera.
As its nickname implies, the Quad is made up of four different medications. These are the new integrase inhibitor elvitegravir (brand name not yet available), plus Viread and Emtriva (tenofovir and emtricitabine—available both separately as well as together under the brand name Truvada), and cobicistat. This fourth drug is not an HIV medication, but a booster agent to improve the bioavailability of elvitegravir. Currently, Norvir (ritonavir) is the only such booster agent available. Elvitegravir would join the only HIV integrase inhibitor currently on the market, Isentress.
For more information on the Quad, go to www.positivelyaware.com/quad.
HIV patients often drop out of care
Only one in five HIV patients maintained a high level of medical care based on three criteria, according to an analysis of 12 clinics in the U.S. The study, published in the April 23 edition of Journal of Acquired Immune Deficiency Syndrome (JAIDS), was based on the medical records of more than 22,000 people receiving care between 2001 and 2009. In looking at the three criteria—establishment of care (a follow-up appointment six or more months after first engaging with care); retention in care (two or more follow-up appointments at least 90 days apart in each year of care); and loss to follow-up (no visit for more than twelve months without return)—the researchers found that: 21.7% of these patients never established HIV care after their first visit; 57.4% did not meet retention criteria; and 34.9% were lost to follow-up. 20.4% of patients established and retained care under the definitions of the study.
“For optimal clinical benefit, HIV-infected patients should receive periodic outpatient care indefinitely,” the researchers stated. “These data highlight the need to improve establishment and retention in HIV care.”
HIV prevention pill recommended
An advisory committee of the FDA recommended that the agency approve the use of the HIV medication Truvada for HIV-negative people to prevent infection with the virus (see story on page 34). The FDA was scheduled to consider the new indication for Truvada in September, as Positively Aware went to press.
An actual indication for prevention on the drug label would make it easier for medical providers to prescribe it and insurers to pay for it.
Another home HIV test
Another FDA advisory committee recommended that the agency approve the OraQuick In-Home HIV Test. Unlike other over-the-counter HIV tests available from Home Access, in which people mail in samples on a swab and get their results over the phone, the OraQuick test results would be available in 20 minutes and can be read right at home, as with home pregnancy tests. An oral swab is used.
HIV the musical: Living with Henry
Living with Henry is the title of a new Canadian musical that explores present day issues of living with HIV such as stigma, disclosure, and interpersonal relationships. The musical will be premiering in New York City this summer from July 23–29 as part of the New York Musical Theatre Festival.
“It has become apparent that there are few, if any, theatrical productions that discuss HIV in the ‘now’ context,” says writer and director Christopher Wilson, who is himself HIV-positive. “Living With Henry is a contemporary theatrical view of HIV/AIDS, framing it as a chronic illness rather than a death sentence.”
Breast milk antibodies help neutralize HIV
Antibodies that help to stop HIV from replicating have been found in breast milk. Researchers at Duke University Medical Center isolated the antibodies from immune cells, called B cells, in the breast milk of infected mothers in Malawi. HIV-1 can be transmitted from mother to child via breastfeeding, but only one in 10 HIV-positive nursing mothers is known to pass the virus to their infants. Research showed that the B cells in breast milk can generate neutralizing antibodies that may inhibit the virus.
The discovery of the two antibodies in breast milk may also help researchers with new investigations into adult-to-adult transmission, as well as to mother-to-child transmission.
“This is important work that seeks to understand what a vaccine must do to protect babies from mucosal transmission during breastfeeding,” said Barton Haynes, MD, co-author and director of the Center for HIV/AIDS Vaccine Immunology (CHAVI), as well as director of the Duke Human Vaccine Institute (DHVI). “The antibodies isolated are the first HIV antibodies isolated from breast milk that react with the HIV-1 envelope, and it is important to understand how they work to attack HIV-1.”
The Centers for Disease Control and Prevention (CDC) recommend against breastfeeding if a mother has HIV-1, because baby formula is a safe alternative for U.S.-born infants. The World Health Organization, however, encourages HIV-positive nursing mothers in resource-poor regions to breastfeed while mother and/or baby take antiretroviral drugs to prevent the infection in the infant. Without the nutrients and immune factors in mothers’ milk, many more babies would die from other diseases.
The study was published May 18 in PLoS One.
Treatment for hep C without interferon
Boehringer Ingelheim (BI) issued a press release on 12-week data with two investigational compounds for the treatment of hepatitis C, BI 201335 and BI 207127. Although not yet studied in people with HIV, it’s a beginning for a new treatment option that can be expected to help people co-infected with HIV and hepatitis C (HCV) in the future. The two drugs were used together, along with ribavirin, but importantly, without interferon, a drug that is very difficult to tolerate, but is currently part of every hep C treatment regimen.
“Eliminating interferon from HCV treatment is an urgent need,” said Stefan Zeuzem, MD. He is Chief of the Department of Medicine and Professor of Medicine at the Johann Wolfgang Goethe University Hospital in Frankfurt, Germany, and lead investigator of the study.
The planned interim results showed that 68% of study participants achieved a sustained viral response (SVR) against their hep C. SVR at 12 weeks has been independently correlated to SVR at week 24, which is considered a cure. The participants (less than 100 of them) had genotype 1, the most difficult type of hep C to treat. The results were presented at the European Association of the Study of the Liver (EASL) conference, held in Barcelona in April.
Clue found to Ziagen and Epzicom hypersensitivity
According to a press release from the FDA issued in May, “A team of researchers led by the U.S. Food and Drug Administration has discovered a new mechanism for identifying and understanding drug-related autoimmune reactions.
“In an article published in the journal AIDS, the team describes that in certain at-risk patients, the anti-HIV drug Ziagen (abacavir) causes the immune system to ‘see’ a patient’s own healthy tissues and proteins as a foreign invader. The affect is similar to what happens when the immune system recognizes a viral or bacterial protein during an infection.”
The agency said the “latest discovery will advance the FDA’s ability to approve therapies that are personalized for safety.”
Ziagen is also found in the two-drug combination pill Epzicom. Both medications can cause allergic reactions that can be serious and even fatal, but the risk has been virtually eliminated by an easy and inexpensive test for the gene HLA-B*5701, which makes people susceptible to the reaction.
Ziagen and Epzicom are rather rarely used in the U.S., with competitor Truvada probably being the number one selling HIV drug in the country.
Activists issue report on HIV cure research
Activists from the AIDS Treatment Activists Coalition (ATAC), Project Inform (in San Francisco), and the Treatment Action Group (TAG, in New York City) issued a report summarizing the talks presented at the Community HIV Cure Workshop, which took place in March in Seattle before CROI. The report received funding support from Bionor Pharma, Gilead Sciences, and Merck.
“A cure for HIV will be essential to ending the AIDS pandemic, but science that is focused directly on a cure is still in early stages and will likely require the support of multiple stakeholders to proceed at the fastest pace,” the report begins. “Among recent signs of progress, researchers have contributed new insights into where and why HIV persists despite potent ARV therapy.” Read the 10-page report at www.positivelyaware.com.
Trending HIV/AIDS on Twitter
Six HIV/AIDS activists are urging Twitterers to use the hashtags #HIV, #AIDS, or #IAC during the International AIDS Conference, being held July 22–27 in Washington, D.C. The suggestion will help to “trend” HIV/AIDS on Twitter, meaning that instead of Kim Kardashian being one of the most talked about topics on Twitter, it could be HIV and AIDS at the top of the list instead.
“Together, through this campaign, we (the global community) can, we must, make #HIV and #AIDS a trend. This is a huge opportunity to bring much-needed awareness to the HIV/AIDS global epidemic. To achieve success, we must all make a conscious effort to tweet our little fingers off!” writes activist Kevin Maloney in a recent blog on TheBody.com. “#HIV: Let’s Trend until the End will redefine how HIV, AIDS, and hepatitis C (along with other sexually transmitted infections) awareness, prevention, outreach, activism, and much more are put into action in areas that are in desperate need of support.”
To participate, RSVP on the campaign’s Facebook event page, and click on “going,” or go to twitter.com/hashtaghiv.
Nickelodeon seeks positive youth
Mallory Kydd, from Nick News with Linda Ellerbee, is looking for youth ages 11-17 to share their stories of living with HIV for a documentary to be aired on World AIDS Day, December 1.
“We are primarily looking for stories that have a lot of depth. For example, the recent news piece about the 13-year-old boy who had his admission rejected at a private school in Pennsylvania,” said Kydd in an email sent to AIDS service organizations.
Anyone interested should contact Kydd at Mallory@LDP.com or 1-212-463-0029.
Justice Dept. settles HIV bias lawsuits
The Justice Department has reached two settlements resolving claims that health care providers refused to serve people with HIV in violation of the Americans with Disabilities Act (ADA).
The first complaint was filed by a man with HIV who went to the Mercy Medical Group Midtown Clinic in Sacramento and was incorrectly told by the podiatrist seeing him that surgery was not an option because of the risk of the surgeon contracting HIV from him.
The second complaint was filed by a man with HIV who went to the Knoxville Chiropractic Clinic North for chiropractic treatment following an automobile accident, where a doctor determined that he needed 24 appointments to treat his injuries. However, he was informed on his third visit that the clinic could not treat people “like him.” The Justice Department determined that the Knoxville Chiropractic Centers had a blanket policy of refusing treatment to people with HIV in violation of the ADA.
“It is critical that people with disabilities, including HIV, not be denied equal access to goods and services, especially to health care services. The Civil Rights Division takes discrimination based on unfounded fears and stereotypes about HIV very seriously,” said Thomas E. Perez, Assistant Attorney General for the Civil Rights Division.
The settlement agreements require the entities to develop and implement a non-discrimination policy and to train staff on the requirements of the ADA. In addition, Mercy Medical Group and CHW Medical Foundation are required to pay $60,000 to the complainant and $25,000 as a civil penalty, and Knoxville Chiropractic Centers is required to pay $10,000 as a civil penalty.
Announcement of the settlements was made in May.
Combivir, Viramune go generic
The FDA has approved generic formulations of the HIV medications Viramune (nevirapine) and Combivir, a combination of Epivir (lamivudine) and Retrovir (zidovudine or AZT). The approvals mean that these generic formulations can be marketed in the United States. The availability of these generics could be problematic for HIV treatment, since in an effort to save money, people could be forced to switch to the cheaper generics from other, more tolerable antiretrovirals. A comprehensive list of the approved generic HIV therapeutic drug products is available on the FDA’s HIV web site.
Isentress drug label update
In May, the FDA approved of a labeling update for Isentress, an HIV integrase inhibitor. The three-year data (156 weeks, from a planned five-year study) showed that 76% of participants given Isentress had reached the goal of viral load less than 50 copies/mL, compared to 68% of the Sustiva group. Moreover, the average CD4+ T-cell increase seen with Isentress was 281 compared to 241 for Sustiva. This study looked at 600 people taking HIV treatment for the first time, a group that is expected to achieve the best results with therapy.