“HIV-positive individuals who smoke cigarettes may be more likely to die from smoking-related disease than the infection itself,” according to a press release on a study published in November 2016 in the Journal of Infectious Diseases (JID). “The study, which analyzed men and women with HIV who take their treatments as prescribed, found that smoking reduces life expectancy by about twice as much as HIV. Now that HIV treatments are so effective against the virus, this research highlights the need to make smoking cessation a priority among this patient population—which has smoking rates more than double that of the general U.S. populations.”
Study author Krishna P. Reddy, MD, of Massachusetts General Hospital and Harvard Medical School, and her colleagues used a computer simulation model of HIV disease and treatment to project estimations of life expectancy.
Reductions in life expectancy for smokers were twice as high as reductions from HIV. Again, this was for people who adhere well to their HIV treatment.
“It is well-known that smoking is bad for health, but we demonstrate in this study just how bad it is,” Dr. Reddy said in the release. “A person with HIV who consistently takes HIV medicines but smokes is much more likely to die of a smoking-related disease than of HIV itself.”
According to the Centers for Disease Control and Prevention (CDC), more than 40% of people living with HIV in the U.S. smoke, compared to 15% of adults in the general population. The discrepancy has long been recognized. Medical providers are urged to ask patients living with HIV about smoking and provide assistance in achieving smoking cessation.
According to the mathematical modeling study, smoking would still equal the cuts in life expectancy—for men—as would be seen with HIV alone for those with imperfect taking of HIV treatment and missed follow-up health care.
As one example, the research team reported that men starting HIV care at age 40 who continued to smoke lost 6.7 years of life—women lost 6.3 years—compared to those living with HIV who never smoked.
On the other hand, if they stopped smoking at age 40, men would gain 5.7 years of life, and women would gain 4.6 years. Basically, they would almost even the score, as if they had never smoked.
But Dr. Reddy said that even people who smoked until age 60 and then stopped “have a substantial increase in their life expectancy compared to those who continue to smoke. So it’s never too late to quit.”
The research team used data from studies of people living with HIV for their findings. The study was funded by the National Institute of Allergy and Infectious Diseases and Massachusetts General Hospital.
Website Name Change
In a sign of the times, aids.gov, the federal government’s HIV information website, has changed its name to hiv.gov. While AIDS has not gone away, the U.S. Department of Health and Human Services says, “today, people with HIV who are diagnosed early, linked to care, start antiretroviral therapy (ART), and take it as prescribed, can achieve life-long viral suppression that prevents HIV infection from progressing to AIDS.”
The U.S. Department of Health and Human Services (DHHS) updated the guidelines for perinatal HIV treatment, recommending that HIV therapy should start as early in pregnancy as possible.
“The Panel now recommends that—based on the preponderance of studies indicating no difference in rates of birth defects for first-trimester compared with later ARV [antiviral] exposures—women can be counseled that ART [antiretroviral therapy] during pregnancy generally does not increase the risk of birth defects,” DHHS reported.
This includes the use of efavirenz (found in Atripla), in accordance with guidelines from the World Health Organization and the British HIV Association, despite the birth defect warning that remains on the drug label. Efavirenz, however, was reclassified from a “Preferred” HIV drug to take in pregnancy to “Alternative” due to its neurological effects. Women who tolerate it well should continue to use it.
However, the relatively new medication tenofovir alafenamide (TAF), which is found in Descovy, Genvoya, and Odefsey, cannot be recommended for pregnant women at this time, due to lack of safety and pharmacokinetic data.
In addition, the section on initial assessment of HIV-positive pregnant women was updated to include intimate partner violence-related screening and supportive care. There is also referral information for HIV testing of sexual partners plus information on the use of PrEP (pre-exposure prophylaxis, or prevention) for the partners.
Among the other updates and changes:
- References to expedited HIV testing, preferably using fourth-generation antigen/antibody rapid tests
- Expanded information on drug interactions between HIV medications and hormonal contraceptives
- Counseling information on the use of Truvada for prevention in HIV-negative partners of women living with HIV
The “What’s New in the Guidelines” section is long, listing 17 items covering such issues as pregnancy for women born with HIV and medicines to prevent HIV in infants born to women living with the virus. The perinatal guidelines were updated October 26, 2016. Go to aidsinfo.nih.gov.
Selzentry approved for children
The U.S. Food and Drug Administration (FDA) has approved Selzentry (maraviroc) for children who are at least two years old and weigh at least 22 pounds (10 kg). The HIV medication was also approved in a new formula and in new pills: a 20 mg/mL oral solution plus 25 mg and 75 mg tablets. Previously, Selzentry consisted only of 150 mg, 300 mg, and 600 mg tablets. The oral solution and the tablets with smaller doses better suit the medication needs of children. The FDA created a table of Selzentry doses for children, based on weight and other medications being taken. Selzentry is taken twice a day.
Read the extensive FDA press release on this approval, including pediatric data, at content.govdelivery.com/accounts/USFDA/bulletins/170a8a2/. You can also go to positivelyaware.com/selzentry for information about the drug. Approval of Selzentry for children came November 4, 2016.
HIV can cause cancer
Not only is HIV a serious illness, it can also cause cancer. DHHS reports that an immune system weakened by HIV “is thought to increase a person’s risk of getting several cancers caused by other viruses, including non-Hodgkin’s and Hodgkin’s lymphomas; anogenital cancers, including penile, vaginal/vulvar, cervix, and anal; Kaposi sarcoma; and possibly oral-related cancers; and liver cancer. It also increases the risk of other types of cancers, including non-melanoma skin cancer, eye cancer, and possibly lung cancer.” Four other viruses were also among the carcinogens added to the list—human T-cell lymphotropic virus type 1, Epstein-Barr virus, Kaposi sarcoma-associated herpesvirus, and Merkel cell polyomavirus. Read the release and report at ntp.niehs.nih.gov/pubhealth/roc/index-1.html.
Bad news from the CDC: “Total combined cases of chlamydia, gonorrhea, and syphilis reported in 2015 reached the highest number ever, according to the annual Sexually Transmitted Disease Surveillance Report,” released October 19, 2016. “There were more than 1.5 million chlamydia cases reported (1,526,658), nearly 400,000 cases of gonorrhea (395,216), and nearly 24,000 cases of primary and secondary (P&S) syphilis (23,872)—the most infectious stages of the disease. The largest increase in cases reported from 2014 to 2015 occurred in P&S syphilis (19 percent), followed by gonorrhea (12.8 percent) and chlamydia (5.9 percent). Chlamydia, gonorrhea, and syphilis are the three most commonly reported conditions in the nation and have reached a record high level.” Read the report at cdc.gov/nchhstp/newsroom/2016/std-surveillance-report-2015-press-release.html.
Paying for lipodystrophy care
In August 2016, the state of Massachusetts passed a law requiring insurance coverage for lipodystrophy in people living with HIV. Although increases in cholesterol and triglycerides are part of the lipodystrophy syndrome and covered by insurance, disfiguring aspects of the condition are considered cosmetic and not eligible for care and reimbursement. For more information, go to glad.org/tlc.
New hep B pill—Vemlidy
The FDA approved tenofovir alafenamide (TAF) as a treatment for hepatitis B virus (HBV), as a medicine called Vemlidy. TAF is also an HIV treatment in the combination pill Descovy and other fixed-dose combinations. Vemlidy was approved by the FDA on November 10, 2016.
New HIV vaccine approach
In the long road to a “functional cure,” in which people living with HIV can keep their virus in check with a vaccination instead of taking medications on a daily basis, researchers have found promise with the combination of new compounds. They presented pre-clinical (very early) data in 36 non-human primates with SIV (a virus similar to HIV) over a two-year period.
Among the findings: the combination of an experimental medication called a TLR7 agonist, which stimulates the immune system, and an experimental therapeutic vaccine worked better than either given alone at lowering HIV “set point.” This is the lowest level of virus reached by an individual. The nine primates given the combination also had less viral load and a longer time to viral rebound (detectable viral load).
Combining the two methods represents a new approach at a functional cure.
Read more about the results published in the November 9, 2016 edition of Nature in a press release at jnj.com/media-center/press-releases/new-therapeutic-vaccine-approach-in-non-human-primates-shows-potential-as-functional-cure-for-hiv-1.
More functional cure potential
In more research looking into a functional cure, researchers reported that the compound VRC01, a broadly neutralizing antibody (bNAb), stopped signs of HIV replication for four weeks after the 24 study participants stopped taking their antiviral regimen. Because the virus did return to detectable levels, the scientists reported that further study is needed, as well as studies that combine bNAbs. Get more information at medicalxpress.com/news/2016-11-antibody-suppresses-hiv-infected-individuals.html, which includes a link to the report published in the New England Journal of Medicine (NEJM).
Accelerating immune therapies
According to Treatment Action Group and the Program for Wellness Restoration, “A coalition of HIV/AIDS activists are calling for renewed attention to HIV-positive people termed immunologic non-responders (INRs), who experience sub-optimal immune system reconstitution despite years of viral load suppression by antiretroviral therapy. Studies have shown that INR patients remain at increased risk of illness and death compared to HIV-positive people who have better restoration of immune function on current drug therapies.” Read the press release at webnewswire.com/2016/11/30/hiv-activists-seek-to-accelerate-development-of-immune-enhancing-therapies-for-immunologic-non-responders/.
New hep C single-table regimen on the way
In December, Gilead Sciences applied for a New Drug Application (NDA) from the FDA for a new single tablet regimen for hepatitis C. The new drug consists of sofosbuvir and velpatasvir, which are already available in the pharmacy, plus a new medication, voxilaprevir. According to a company press release, Gilead submitted data supporting the use of the regimen for 12 weeks of treatment for patients with genotypes 1–6 with either cirrhosis or compensated cirrhosis. These patients had experience with direct-acting antivirals for hepatitis C. Read the release at gilead.com/news/press-releases/2016/12/gilead-submits-new-drug-application-to-us-food-and-drug-administration-for-the-investigational-single-tablet-regimen-sofosbuvirvelpatasvirvoxilaprevir.
‘Fear and Discrimination’
The new documentary HIV Criminalization: Masking Fear and Discrimination tells the story of unjust laws used against people living with the virus, which SERO Project executive director Sean Strub called “a defining moral issue” for HIV activists. The SERO Project, a U.S.-based network of people living with HIV and their allies, released the film on World AIDS Day, December 1, 2016. The network fights stigma and injustice facing people living with HIV, particularly in unjust criminal prosecutions. The film is directed by Christopher Kind and produced by Mark S. King. Go to seroproject.com.
Report on long-term survival with HIV/AIDS
On World AIDS Day 2016, the first chronicle of its kind describing a series of unique health and psychosocial challenges in HIV/AIDS survivors was released. The Unintended Consequences of AIDS Survival is a 24-page status report that calls attention to the lives of long-term survivors, who feel their psychosocial needs are not prioritized in the AIDS landscape. This, added to earlier physiologic aging now widely studied in survivors with years of traumatic stress and unprocessed grief, has essentially become the rallying cry for a new HIV movement. Written by long-time activist and survivor Matt Sharp, the report details the history of the epidemic and its lasting effects on those who have been HIV-positive for decades. Special needs and challenges for long-term survivors are examined, along with community responses from around the country. The report was funded by Bristol-Myers Squibb.
Exonerating ‘Patient Zero’
In the early days of the AIDS epidemic, Canadian flight steward Gaétan Dugas was branded “Patient Zero.” However, more recent scientific findings discredit this claim, saying Dugas could not have possibly started the U.S. epidemic. The report in the Spring 2014 Bulletin of the History of Medicine, written by Richard A. McKay, is a fascinating account of AIDS panic, sensationalism, and stigma.
In his introduction, McKay notes that, “[This] article also traces how [Randy] Shilts’s highly selective—and highly readable—characterization [in his book And the Band Played On] of [Gaétan] Dugas rapidly became embedded in discussions about the need to criminalize the reckless transmission of HIV.” McKay is a Wellcome Trust research fellow in the Department of History and Philosophy of Science at the University of Cambridge. His book on this story is due for publication this year by the University of Chicago Press. Go to ncbi.nlm.nih.gov/pmc/articles/PMC4046389/#f40. The New York Times published a lengthy article on the findings on October 26, 2016; read it at nytimes.com/2016/10/27/health/hiv-patient-zero-genetic-analysis.html?smid=fb-share.
Mirror Memoirs project
Mirror Memoirs is a nationwide project looking for stories and leadership of LGBTQ people of color in the emerging movement to end child sexual abuse. Founder Amita Swadhin writes that, “The project builds an audio archive of at least 50 survivors’ stories, will release a report aimed at service providers, philanthropists, and advocates, and will convene survivors and allies together in 2017 (in conjunction with the California Coalition Against Sexual Assault).” Childhood sexual assault is a known risk factor for acquiring HIV infection later in life. For more information, go to mirrormemoirs.com.
CDC’s ‘fabulous’ gay dance video
“The Centers for Disease Control and Prevention (CDC) has taken the unprecedented step of producing a music video to educate gay men about the many HIV prevention options available to them, and it is foot-stomping fabulous,” writes Mark S. King, in his blog, My Fabulous Disease. “The song, Collect My Love, was released last year by The Knocks, and features vocals by the inimitable Alex Newell, the young gender-bending singer who rose to fame by stealing season three of the television series, Glee. (His rendition of Boogie Shoes on the show is a one-way ticket to my happy place.) The CDC invited Newell to participate in a new music video for the song, and it’s a perfect fit for their outreach to young gay men of color.” Read more at marksking.com/my-fabulous-disease/cdcs-gay-dance-video-hiv.