POSITIVELY AWARE January/February 2012
IAS Conference updates from Rome
Complera and Atripla news
Last summer, 48-week data won FDA approval for Complera (see the November+December 2011 Briefly for the complicated details). At IDSA, 96-week data were presented from the ECHO and THRIVE studies that pitted the new Complera against Atripla. Complera continued to be non-inferior to Atripla, but also continued to have more virologic failure in people who started therapy at viral loads greater than 500,000.
There was bad news for people who began Complera with a viral load of greater than 100,000, as well. The researchers conducted a so-called “snapshot” analysis, looking at viral load measurements made between 96 and 103 weeks. Here, the virologic failure was almost twice as high for Complera: 22% vs. 12% for Atripla. Moreover, virologic failures leading to treatment discontinuation were also higher with Complera: 12% vs. 4% for Atripla.
On the plus side, Complera also continued to be more tolerable. The treatment discontinuation rate for adverse events was 4% for Complera compared to 9% for Atripla, a statistically significant difference. These figures were about double those of week 48 (2% vs. 5% respectively).
As leading HIV specialist and researcher Cal Cohen of the Community Research Initiative of New England said, “For the right person, Complera is a good drug. and it’s important to consider for those who want the benefit of taking a single tablet once daily, and for whom Atripla isn’t the right choice.”
Switching from Atripla to Complera
Now that the best-selling Atripla has a real competitor, an important question becomes, can people switch from Atripla to the new Complera?
While switching to a new and improved drug or regimen is common, there was a concern about switching here because of the way these drugs act in the body. The Sustiva in Atripla activates the protein (or enzyme) CYP34A. This is the same enzyme that the body uses to metabolize the Edurant in Complera. Sustiva has a long half-life and therefore drops the blood levels of Edurant; because there’s too much metabolism of Edurant going on, the body eliminates it.
That interaction was recognized thanks to an earlier study that found a drop in Edurant blood levels of about 25% for approximately four weeks in volunteers switching from Sustiva to Edurant.
Fortunately, an HIV study presented at both ICAAC and IDSA has now shown that patients were able to maintain undetectable viral loads when switching from Atripla to Complera, out to three months. There was only a small temporary drop in Edurant blood levels.
At ICAAC, Dr. Tony Mills of Los Angeles made a poster presentation on the 49 patients switching from Atripla to Complera because of problems with tolerability. Atripla was their first HIV regimen and they had been taking it for at least three months (the average was 2.5 years). At week 12 after the switch, all 49 still had undetectable viral loads of less than 50 copies per mL.
The study did see lower than expected blood levels of Edurant at week one, but not at the other weeks in which bloodwork was collected (2, 4, 6, 8, and 12). The study concluded that “brief [Sustiva] inductive effects on [Edurant] metabolism may not be clinically relevant in suppressed patients [those with undetectable viral loads],” since all viral loads were undetectable at 12 weeks. The study also reported that Complera was well tolerated.
Isentress for four years
The longest-term data on Isentress to date, presented at IDSA, show better virologic (viral load) and immunologic (T-cell count) results than Sustiva, out to 192 weeks (nearly four years).
STARTMRK is a non-inferiority study, but was able to demonstrate virologic superiority over Sustiva at 192 weeks based on pre-specified data standards.
At 192 weeks, 76.2% of the 281 people on Isentress vs. 67% of the 282 individuals taking Sustiva had undetectable viral load of less than 50 copies per mL. The Isentress group also saw a greater increase in their CD4+ T-cell counts, 361 vs. 301 for those on Sustiva.
Isentress was also more tolerable, with 50% of the people taking it experiencing a “drug-related clinical adverse event” compared to 80% of those taking Sustiva. Discontinuations due to adverse events were also lower with Isentress: 5% vs. 8.2% for Sustiva. In terms of what’s called “serious adverse events,” there was a similar rate: 17.8% for Isentress and 18.4% for Sustiva.
Isentress, like Sustiva, is one of the medications recommended by the Department of Health and Human Services HIV treatment guidelines for people taking antiviral therapy for the first time.
Risky business and PrEP interest in Chicago STI clinic
Chicago researchers surveyed patients at a clinic treating sexually transmitted diseases about condom use, perception of HIV risk, and acceptance of PrEP (pre-exposure prophylaxis, the use of medication to prevent HIV infection).
At ICAAC, they presented an analysis of 359 heterosexuals deemed at high risk for HIV infection and found that the vast majority (84%) saw themselves as being at no
or low risk of HIV infection.
The two risk factors that were significantly different between the men and the women were having ever been in a jail or prison (55% of men and 23% of women) and having ever exchanged sex for money or drugs (6%of men and 15% of women).
HIV specialist Dr. Kimberly Y. Smith of Rush University Medical Center, one of the leaders of this study, said that women may not recognize that incarceration increases the risk of HIV for their male sex partners and in turn, for the women themselves. The women don’t want to believe that their male partners are engaging in sex with other men while incarcerated, whether consensual or not, nor do they recognize other incarceration risk factors such as sharing needles for drug use or tattooing.
Dr. Smith said that when talking with heterosexual or bisexual men who have been incarcerated or have HIV, they will often have kept their sexual contact with other men or their HIV infection a secret from female sex partners.
According to U.S. government data, the prevalence of AIDS among U.S. prisoners is three times that of the general population, and approximately one in five people with HIV will be incarcerated at some point. A factsheet from the Centers for Disease Control and Prevention (CDC), states that incarceration risk factors of unsafe tattooing, sex, and drug use “coupled with the sexual relationships and socioeconomic consequences faced by persons with histories of incarceration, make prisons a risk factor for HIV infection.”
The majority of the individuals surveyed in Chicago were people of color (75% black and 15% Latino). In this public clinic (CORE Center), there was a high level of poverty: nearly half (45%) had household incomes of less than $499 a month. Only a third of them were employed and 79% had only a high school education or less.
Half of the 234 men in this study had two or more sex partners in the month before being surveyed, including at least one new sex partner in that time period.
The majority of participants also reported high levels of inconsistent condom use (81 to 96%), with both vaginal and anal intercourse. One-fifth (21%) of both men and women reported having had anal intercourse.
Other risk factors included drinking alcohol or using drugs at least half of the time when having sex, and having a sexually transmitted infection (STI) within the past year.
Some risk factors were based on a partner’s behavior (STI within past year; ever exchanging sex for money or drugs; drug use within past 30 days; and ever being in jail or prison).
When asked about taking medication for the prevention of HIV, 83% of the participants said they would take a pill for PrEP. Their preference for taking PrEP was lowest for daily use (63%) and 75% preferred taking it an hour before sex, a day before sex, or a week before sex.
Among the audience at the presentation were doctors who thanked the researchers for reminding everyone that women engage in anal sex and who pointed out that surveys of gay and bisexual men have also found low perceptions of HIV risk in the face of risky behavior or actual infection. One audience member questioned the perception of low risk in light of the fact that these individuals were being seen in an STI clinic. Presenter Dr. Thana Khawcharoenporn said the participants showed a disassociation between their high level of knowledge of risk factors and the assessment of their own risk.
Included in the presentation was information on an earlier study by Denise Dion Hallfors and colleagues that found blacks in the U.S. are at higher risk of HIV despite normative (the same) behavior as whites, that they perceive themselves to be at low risk based on their own actions instead of the risk behaviors of their sex partners, and that the perception of low risk may be associated with ongoing risky behavior and lack of prevention strategies.
Kudos to the researchers at Rush, CORE Center, and Stroger Hospital (Chicago’s public hospital) for gathering this information.
Germ Stories - A Children' s Book
The organizer of ICAAC, the American Society for Microbiology, took on a very different project by lending photographs by Roberto Kolter to be used in a children’s picture book called Germ Stories, by Nobel Prize-winning enzymologist Arthur Kornberg. Cute illustrations by Adam Alaniz round out the photos and text.
The HIV germ story centers on a schoolboy named Bill who has hemophilia.
The very short story goes on to explain how unlikely the virus is to be transmitted at school, and how medication keeps Bill well. Other germs visit other children—yeast and food poisoning, pneumonia, and more.
Unfortunately, AIDS is referred to as “acute immunodeficiency syndrome” instead of “acquired.” And “dread disease” is an unfortunate reference. But did you know that “a measly grain of sand is 8,000,000,000 times bigger than a single particle of HIV”? All in all, the book is a dynamic combo of rhyme and science, which may or may not delight any particular child.
Germ Stories —a children’s book
The organizer of ICAAC, the American Society for Microbiology, took on a very different project by lending photographs by Roberto Kolter to be used in a children’s picture book called Germ Stories, by Nobel Prize-winning enzymologist Arthur Kornberg. Cute illustrations by Adam Alaniz round out the photos and text.
Raphael J. Landovitz, MD, of UCLA said he was going to show “how to meet a gay man in five easy steps—GRINDR 101.” The greater purpose of his presentation, however, was to give the results of a survey of young gay men using the social networking app and discuss how it might be useful for HIV prevention. In Los Angeles, as in the United States, he said, men who have sex with men (MSM) acquire the majority of new HIV infections, with those age 20–29 having the higher incidence (new infections) in that city. In the U.S., the majority of MSM with new infections are ages 13–29 (nearly four out of 10).
Dr. Landovitz reported that GRINDR boasts two million users worldwide, with 8,000 more joining each day and 280,000 logged on at least daily. GRINDR allows its users to locate each other geographically by using GPS functionality. An example put up on the screen was of a 27-year-old Latino located 81 feet away. He was single and looking for “dates, friends, and networking.”
“Some of you may not be familiar with GRINDR,” Dr. Landovitz said. “Some of you may be logged on to it right now,” at which the audience broke out laughing.
In one slide, Landovitz pretended to show two audience members logged on. He presented their exchange on the screen.
“Hey—you’re hot [referring to the person’s profile photo]!”
“Thanks! U2. Where u at?”
“ICAAC.”
“No way. Me too!”
“Presentation on GRINDR. Interesting, but the presenter is a dork.”
They make arrangements to meet up later.
According to the research group’s abstract, “Young MSM (YMSM) in Los Angeles age 20–29 have the highest HIV incidence rates of any age-risk population segment in the city. YMSM are technology savvy and use GPS-based social networking ‘apps,’ such as GRINDR, to facilitate sexual partnering. GRINDR has more than [two] milliion users and more than 46,500 users in L.A. GRINDR may be a tool to access hard to reach communities.”
Was it? In their abstract conclusion, they report that, “GRINDR was a feasible and acceptable method to recruit a sample of YMSM. Most complied with CDC-recommended annual HIV testing. Prevalence of self-reported HIV was similar to data from other recruitment techniques in YMSM; this suggests little bias by HIV status in this sample. With high rates of reported STIs and risk behavior, the sample is at high risk for HIV acquisition. On GRINDR, fewer HIV-positives inquired about partners’ HIV status than HIV-negatives, suggesting less serosorting [picking partners of the same HIV status]. GRINDR may be a mechanism for providing HIV prevention messaging and interventions.”
The research group used areas of Los Angeles frequented by young MSM. GRINDR members identified as 18 to 29 years of age were eligible for the survey. Of 4,808 contacts made over five months, only 375 individuals (7.8%) were recruited into the survey. Their age ranged from 22 to 27. The greatest number of them were white (42.4%), followed by Latinos (33.6%), Asian (14.1%), and African Americans (6.4%).
Of these, 83.2% had been tested for HIV in the past year, with 4.3% reported having never been tested for the virus. The men reported having had gonorrhea (17.9%), Chlamydia (13.6%), and syphilis (9.1%). The average number of partners for anal sex in the previous year was 10. More than half (56%) had found a sex partner through GRINDR in the previous three months and 41% reported inconsistent condom use for receptive anal sex. While 98% reported sex with men in the previous year, 10% reported having sex with women in that time period, two reported sex with transgender women, and one reported sex with a transgender male.