Researchers Stress the Importance of Screening Women for Precancerous Anal Lesions

via AIDSmeds, by Tim Horn

Results from a study conducted in the Bronx, New York, serve as an important reminder to HIV care providers: Comprehensive screening for precancerous anal lesions isn’t of importance only to HIV-positive men who have sex with men (MSM). According to the Journal of Acquired Immune Deficiency Syndromes report by researchers at Albert Einstein College of Medicine in the Bronx, precancerous lesions are also common among women living with HIV—and testing for them using anal swabs alone may not be sufficient to rule out problems requiring biopsies.

Numerous studies have noted high rates of anal cancer among MSM. According to one study cited by June Hou, MD, and her colleagues at Albert Einstein, the incidence of anal cancer among MSM is 10 to 50 times that of the general population and comparable to cervical cancer incidence rates before the implementation of now-routine screening practices.

Among HIV-positive women, some studies put the incidence of anal cancer at seven to 28 times greater than the general population. Though the incidence of anal cancer has not been nearly as well studied in HIV-positive women compared with HIV-positive MSM, the confirmed higher rates of precancerous lesions—which can occur among women living with HIV, even if they’ve never engaged in anal sexual intercourse—remain a concern.

Yet there is no consensus between national and local groups on anal cancer screening among people living with HIV, either male or female. “Since 2007,” Hou and her colleague explain, “the New York State Department of Health (NYS DOH) has recommended annual anal cytology”—Dacron swabs analyzed by a laboratory—“in HIV-infected subjects with a history of [anal warts] or with abnormal cervical/vulvar histology, along with referral for high resolution anoscopy (HRA) in those with abnormal anal cytology or abnormal findings on anal exam. In contrast, the Department of Health and Human Services guidelines discourage screening and treatment programs for [anal intraepithelial neoplasia, or AIN] due to a lack of complete understanding of the relative harms and benefits of anal cytology screening.”

In turn, to better understand the incidence of precancerous anal lesions and the value of routine anal cytology, Hou and her colleagues conducted a study among women in the Bronx, which has one of the highest HIV prevalence rates in the country, representing 3 percent of the total U.S. HIV burden.

Read the Rest.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Increased risk of anal cancer for all groups with HIV, not just MSM

via Aidsmap, by Michael Carter

Gay men are not the only group of HIV-positive patients who have an increased risk of anal cancer, according to North American research published in the online edition of Clinical Infectious Diseases. The researchers found that incidence of the cancer was also significantly higher in non-gay HIV-positive men as well as HIV-positive women when compared to individuals in the general population.

“We confirmed that HIV-infected MSM [men who have sex with men] experienced the greatest risk of anal cancer,” write the authors. “We also found that both HIV-infected other men and women had substantially higher rates than HIV-uninfected men and women, and that HIV-infected other men and women had similar rates.” They believe that their findings may have implications for anal cancer screening strategies.

Thanks to improvements in HIV treatment and care the prognosis of many HIV-positive patients is now near normal. However, HIV-positive patients appear more likely to develop certain malignancies, including anal cancer, compared to their HIV-negative peers.

Understanding the incidence of anal cancer in the different populations affected by HIV can help develop strategies to prevent the cancer.

Therefore investigators from the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD) analysed findings from 13 US and Canadian studies. Their aims was to determine incidence of anal cancer in HIV-positive patients, who were divided into three categories – MSM, other men and women.

Rates of anal cancer in these HIV-positive patients were compared to those observed in HIV-negative men and women. Analyses were also conducted to see if there were temporal trends in anal cancer incidence, and if any specific risk factors for the malignancy in HIV-positive patients could be identified.

A total of 34,000 HIV-positive patients (55% MSM, 19% other men, 26% women) and 110,000 HIV-negative controls (90% men) were included in the study.

Data gathered between 1996 (the year effective HIV therapy first became available) and 2007 were examined by the investigators.

Incidence of anal cancer in MSM was 131 per 100,000 patient years. Among HIV-positive other men incidence of the malignancy was 46 per 100,000 years, and incidence in HIV-positive women was 30 per 100,000 person years. Incidence was therefore significantly higher in HIV-positive MSM compared to other men (p < 0.01). However, incidence rates for HIV-positive other men and women did not differ significantly.

Read the rest.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Electrocautery ablation safe and effective to treat anal lesions

via aidsmap, by Michael Carter

A clinic-based intervention offers safe and effective treatment for high-grade pre-cancerous anal lesions, US investigators report in the online edition of the Journal of Acquired Immune Deficiency Syndromes.

Doctors at the Mount Sinai School of Medicine, New York, used a technique called electrocautery ablation to treat pre-cancerous anal lesions in 232 gay men, 132 of whom were HIV-positive.

Eighteen months after treatment, 83% of HIV-negative men and 69% of those with HIV were free of high-grade pre-cancerous anal lesions.

“Electrocautery ablation of high-grade anal squamous intraepithelial lesions is a safe and effective office-based procedure comparable to other available treatments,” comment the investigators.

Incidence of anal cancer has increased dramatically among gay men in recent years. HIV-positive gay men appear to be especially vulnerable to the disease, and its incidence is five-times higher in these patients compared to HIV-negative men.

Infection with high certain high-risk strains of human papillomavirus can cause cell changes in the anus, resulting in the formation of lesions. The severity of these changes is graded, and between 9% and 13% of high-grade lesions progress to anal cancer.

There are a number of treatments for these pre-cancerous lesions including infrared coagulation and topical creams such as imiquimod.

Another therapy is electrocautery ablation. The investigators described the procedure thus: “Using a gentle brushing technique the lesion was ablated [worn down] by moving [a] blade lightly across the surface like a paint-brush.” The therapy has a number of advantages and can be performed in clinics without the need for anaesthetic or sedation.

Investigators wished to assess the safety and effectiveness of this procedure. They therefore retrospectively analysed the notes of gay men who had the treatment between 2006 and 2010. The patients received an initial treatment and were then followed at intervals of three to six months and were provided with additional treatment if necessary.

Read the rest.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Getting to the Bottom of It

via Positively Aware, by Gary Bucher, MD, FAAFP

I have witnessed and taken part in the many changes in HIV care over the past 25 years. At the beginning of the epidemic, silence and fear was the name of the game. It took HIV activists taking control of their health care destiny to force the medical community to treat the disease and the patient.

HIV is now a chronic treatable disease, but it has a whole new set of issues regarding conditions related to prematu cian should feel for any tender areas, thickened lesions, shallow indentations, firm masses, or other abnormalities. I also ask the patient if they have performed an anal self-exam by using their finger to feel around for any lumps or bumps inside their anus. This can help guide me when I perform the digital anorectal exam.

Anal Pap smears are performed in a similar fashion to cervical Pap smears, with the area being swabbed to collect cells, which are then examined under a microscope. They can detect abnormal cells (anal dysplasia), but the anal Pap smear may be less likely to correlate with the degree of anal dysplasia that can be seen on a biopsy of an anal lesion revealed by high resolution anoscopy (HRA). Because such specificity is lacking, and there haven’t been any evidence-based clinical trials to evaluate anal cancer screening methods in preventing anal cancer, many clinicians feel that anal Pap smears should not be done at this time. However, I agree with other experts in the field who have proposed yearly anal Pap smears for all HIV-positive individuals. If the anal Pap is normal, continued annual screening is suggested. Experts also recommend anal Pap smears every one to two years for other high-risk groups and if normal, continued screening every two or three years. If any abnormal cells are detected, HRA with biopsy is recommended. However, these guidelines may be limited by the need to train a greater number of clinicians in performing HRAs and biopsies. It is also important for these screening tests to be administered in a non-hospital setting, to maximize patient compliance with screening and follow-up.

High-risk HPV subtypes, especially 16 and 18, are associated with cervical, anal, penile, vulvar, vaginal, and oral cancers. Cervical cancer is an AIDS-defining malignancy and its incidence has been decreasing with aggressive screening and treatment of pre-cancerous lesions or higher grade cervical dysplasia. Cervical cancer affected 35-40 per 100,000 women in the general population prior to cervical cancer screening and treatment and has now decreased to about 8-10 per 100,000.

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[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

HPV Vaccine Protection Against Anal Disease in Men: Controversy About Meaning of Results

via Medscape, by Nick Mulcahy

In young men who have sex with men (MSM), the human papillomavirus (HPV) quadrivalent vaccine (Gardasil, Merck) reduced the rates of anal intraepithelial neoplasia (AIN), compared with placebo, according to an international team of investigators.

The study on the vaccine was published in the October 27 issue of the New England Journal of Medicine.

"Our study suggests that [the quadrivalent] HPV vaccination could be a tool for preventing anal HPV-related disease, potentially even cancer," write the investigators, led by Joel M. Palefsky, MD, professor of medicine at the University of California at San Francisco.

Dr. Palefsky and his colleagues are referring to the fact that an estimated 80% to 90% of anal cancers in American men are related to HPV.

The results of this study were first presented at a European conference and at the federal Advisory Committee on Immunization Practices (ACIP) in 2010, as previously reported by Medscape Medical News.

At that time, a critic said that the study neither proves that anal cancers can be prevented by the vaccine nor robustly proves that the type of AINs that are of the most concern as precancers are prevented.

That critic, Diane M. Harper, MD, professor of medicine in the Departments of Community and Family Medicine, Obstetrics/Gynecology, and Informatic Medicine and Personalized Health at the University of Missouri–Kansas City School of Medicine, has been involved in clinical trials of HPV vaccines in women.

But, in a 2010 interview, Dr. Palefsky told Medscape Medical News that study's data are "strongly suggestive" of cancer prevention and that Gardasil has proven effectiveness against warts, which is a protection that is highly meaningful to MSM.

"Gardasil will prevent both external genital warts and anal warts, and all indications are that it will prevent cancer with the 2 most important cancer-causing types: HPV 16 and 18," he said. The "indications" that Dr. Palefsky refers to are the efficacy data in the study related to both biopsy-proven lesions and swab-detected persistent infections.

The published study also indicates that Gardasil reduced the incidence of anal condyloma, "a substantial added benefit of vaccination," according to the authors.
In their paper, the authors acknowledge that Gardasil has not been proven to prevent anal cancer and that the study was not expected to show that result. At the same time, they say that "vaccination may be the best long-term approach to reducing the risks of both anal cancer and anal condyloma."

The vaccine was well tolerated. "The proportion of participants who reported serious adverse events or who discontinued the study owing to an adverse event was relatively low and was similar in the 2 groups," write the authors. About 58% of men in both the placebo and vaccine groups had injection-site reactions, and 18% had some sort of systemic reaction in both groups.

Efficacy Details

The new data on Gardasil in MSM come from a trial known as protocol 020, which involves 4065 young men, including 602 MSM (aged 16 to 26 years), and tests the ability of the vaccine to prevent the abovementioned external genital lesions.

However, in the paper, which is a substudy, the primary efficacy objective was the prevention of AIN or anal cancer related to infection with HPV 6, 11, 16, or 18.

The authors report on 2 populations of MSM in the study — the intention-to-treat population (n = 551) and the per-protocol efficacy population (n = 402).

In the per-protocol efficacy population, 5 men in the vaccine group and 24 men in the placebo group developed an AIN related to HPV 6, 11, 16, or 18.

In the intention-to-treat population, 38 men in the vaccine group and 77 men in the placebo group developed an AIN related to HPV 6, 11, 16, or 18.

These figures translate into an efficacy of the vaccine against AINs associated with HPV 6, 11, 16, or 18 of 77.5% (95% confidence interval [CI], 39.6 to 93.3) in the per-protocol population and 50.3% (95% CI, 25.7 to 67.2) in the intention-to-treat population, report the authors.

Focus on AIN Grade 2/3 Caused by HPV 16 or 18

Dr. Harper suggested that the study's end point in MSM — the combined incidence of AIN related to HPV 6, 11, 16, and 18 — is a case of mixing apples and oranges.

AINs caused by HPV 6 or 11 is not considered precancerous or carcinogenic, whereas grade 2 and 3 AINs caused by HPV 16 or 18 are precancerous, she explained.

"AIN caused by HPV 6 or 11 is immaterial, as this is never carcinogenic," said Dr. Harper in an earlier interview.

The study authors touch on this subject too, but with a different emphasis. HPV 6 or 11 "alone are rarely causal," they write.

Dr. Harper continued her criticism by saying that the study's primary end point is "a composite end point that hides the true efficacy."

Dr. Harper focused her comments on the data from the per-protocol population. To have been included in the per-protocol analysis, the young men in the study had to have been free of HPV infections from the time of enrollment until a month after the last vaccine dose. The men in this population were followed for a mean of 2.2 years after month 7, the time of last dose.

Dr. Harper noted that, of the 5 cases of AIN in the vaccinated men, 3 infections were related to HPV 6, and 2 were related to HPV 16. Only by combining the noncancerous and precancerous anal lesions did the investigators achieve statistical significance, compared with placebo, with this efficacy finding, she explained.

Dr. Harper also said that more data are needed to strongly prove that Gardasil is effective against high-grade precancerous anal lesions (AIN grade 2 or 3) caused by the 2 most common cancer-causing HPV types — 16 and 18.

She explained that Merck, at ACIP, revealed data that indicated that the point estimate of efficacy of Gardasil against AIN grade 2/3 caused by HPV 16 or 18 was 86.6% (95% CI, 0.013% to 100.000%). Dr. Harper described this as "evidence, but rather weak evidence," of the effectiveness of Gardasil against these lesions.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

HPV Vaccine Protects Women Against Anal Infection

via Medpage Today

A vaccine against human papillomavirus (HPV) protects women against two strains of the virus that causes anal cancer, researchers reported.

The vaccine (Cervarix) against HPV strains 16 and 18 offered "strong protection" against anal infection in a study whose main goal was to assess the efficacy of vaccination against cervical infection and pre-cancerous lesions, according to Aimée Kreimer, PhD, of the National Cancer Institute, and colleagues.

The protection was higher in women who did not have HPV infection when they were first given the vaccine, Kreimer and colleagues reported online in The Lancet Oncology.

Anal cancer is rare in women, with an annual incidence of about 1.5 per 100,000, but rates are rising, the researchers noted. The rate is higher than for men in general, but markedly lower than for men who have sex with men or those with HIV.

Most anal cancers are caused by HPV, with strains 16 and 18 responsible for up to 80% of cases, Kreimer and colleagues noted.

They tested the vaccine against anal infection in a subgroup of young adult women, ages 18 through 25, who enrolled in a community-based randomized trial of cervical vaccine efficacy in Costa Rica.

The 6,352 participants who came for the final blinded study visit, four years after their first of three vaccine shots, were asked to give an anal sample, and 4,210 did so, with a median follow-up of 48.1 months.

The researchers analyzed anal infection in the whole cohort and also in a subgroup of women who had been negative for HPV DNA and antibodies at the start of the trial. Patient characteristics in both groups were well-balanced, the researchers reported, including the proportions who got the vaccine and those who were in the control group, given hepatitis A vaccine.

Kreimer and colleagues found...

Read the rest.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

HIV Drug Shuts Down Precancerous HPV-Infected Cells

via AIDSmeds

The antiretroviral (ARV) drug lopinavir (found in Kaletra) is able to kill cervical cells infected with the human papillomavirus (HPV)—cells that can go on to become cancerous—according to a study published online May 5 in the journal Antiviral Therapy.

HPV is one of the most widely spread viruses in the world. Transmitted through sexual contact, some strains cause genital warts, while others can cause cells to mutate and become cancerous, thereby leading to cervical cancer, anal cancer, penile cancer and cancers of the head and neck.

Though there is now a vaccine against several strains of HPV, it can only prevent HPV. It doesn’t protect someone already infected from developing cancer. Also, HIV-positive women have much higher rates of cervical cancer than women without HIV, and cervical cancer is a leading cause of death in both HIV-positive and HIV-negative women in resource poor countries.

In announcing the new findings, the study’s senior author—Ian Hampson, PhD, from the University of Manchester in England—noted that he and his colleagues were the first to document that lopinavir could be toxic to HPV, as reported in a fall 2006 issue of Antiviral Therapy.

Read the rest.



[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Description of a Pilot Anal Pap Smear Screening Program Among Individuals Attending a Veteran's Affairs HIV Clinic

via AIDS Patient Care and STDs

Isabella Rosa-Cunha, Vincent A. DeGennaro, Rene Hartmann, Clara Milikowski, Andres Irizarry, Brenda Heitman, Orlando Gómez-Marín, Gordon M. Dickinson. AIDS Patient Care and STDs. April 2011, 25(4): 213-219. doi:10.1089/apc.2010.0233.

Abstract

Despite the higher risk of anal cancer among HIV-infected individuals currently there are no national or international guidelines for anal dysplasia screening. We assessed acceptance and feasibility of screening for anal intraepithelial neoplasia (AIN), the rate of abnormalities, and relationship between the presence of AIN and a history of receptive anal intercourse. Eighty-two percent of HIV-patients approached during routine clinic visit agreed to participate in the study with anal Pap smear collection; 53% had abnormal cytology results and among those undergoing high-resolution anoscopy with biopsy, 55% had high-grade AIN, including 2 cases of carcinoma in situ. Anal cytology was well accepted and it was feasible to be incorporated into HIV primary care practice. Abnormal cytology was not significantly associated with history of anal intercourse (p = 0.767). The high rate of abnormal results reinforces the need for further evaluation of the role of systematic anal Pap smear screening for HIV patients.

Read the whole paper.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

High prevelance of anal pre-cancerous lesions in men with HIV

Via Aidsmap, by Michael Carter



Prevalence and incidence of high-grade pre-cancerous anal lesions in HIV-positive men who are taking antiretroviral therapy are high, Canadian investigators report in the online edition of Clinical Infectious Diseases. A low nadir CD4 cell count and infection with HPV types 16 and 18 were associated with an increased risk of developing high-grade pre-cancerous anal lesions (AIN-2, 3). The investigators hope that their findings will help identify patients who have a higher risk of HPV-associated anal disease.

Rates of HIV-related opportunistic infections have fallen significantly since the introduction of antiretroviral therapy.

However, the incidence of anal cancer is increasing.

Most of the information about the risk factors for this disease in HIV-positive gay men was obtained during the era before effective antiretroviral therapy became available. These include high-grade pre-cancerous lesions, infection with HPV 16 and 18, multiple HPV infections and CD4 cell count.

Investigators from the Canadian Human Immunodeficiency and Papilloma Virus Research Group (HIPVIRG) wanted to establish a comprehensive understanding of the risk factors for progression to AIN 2 and 3. They also wished to see if treatment with anti-HIV drugs had any impact on disease progression.

A total of 247 men who were taking or about to initiate antiretroviral therapy were recruited to the study between 2002 and 2005. The patients had swabs to see if they had anal HPV infection, and if present further tests were conducted to determine whether strains associated with anal cancer were present.

Read the rest
 
[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Pittsburgh's Dynamic Rectal Duo

IRMA Scientific Vice Chair Ian McGowan and his research/life partner, Ross Cranston (also a member of the IRMA Steering Committee) are featured in CUE Pittsburgh this month. They talk about our favorite topic - rectal microbicides - and a trial taking place right in Pittsburgh that gay men can get involved in.

The article, below, starts on Page 17. Use the arrows on both sides of the magazine to "flip" pages forward and back.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

HPV and Anal Cancer in Older Women: Risk and Prevention

via Women's Voices for Change, by Patricia Yarberry Allen, M.D.

Excerpt:

Although it has not been documented rigorously, there is a reason to believe that anal cancer could develop very much the way cervical cancer does. The change in the cells begins with mild atypica, progresses to more serious abnormal change (mild, moderate and severe dysplasia), before developing into frank anal cancer. Doctors have known about the relationship of HPV and anal cancer from long experience with gay men, who have a high incidence of this cancer due to receptive anal sex practice. We need the expertise of these physicians, now that HPV has been recognized to be a growing concern for women and recognized as a cause of cervical, vaginal, and vulvar cancer and is now publicly discussed as a cause of anal and oral cancer.

It is important that colo-rectal surgeons develop expertise in high-resolution anoscopy and an interest in recognizing abnormal change at an early stage. Gynecologists are specially trained in colposcopy to view and recognized abnormal cellular patterns that can be biopsied, diagnosed, and treated.  It takes time and training to become very good at these procedures.

At the moment, there is no consensus among our specialities about how to monitor for and evaluate the presence of anal HPV. An HPV swab test can be done in the anal area. Pap smears can be done in this area. But there are no national guidelines for primary care doctors about when to do these tests, and no guidelines about what to do with the results. We don’t have a treatment protocol for anal dysplasia that is universally used.

The result is that women with high-risk HPV of the genital area are almost never tested for anal HPV, even if the woman expresses concern about her risk. That means that cells that could be treated earlier, before there is frank malignancy, are not found.

We don’t want women to wait for a diagnosis until they have rectal bleeding or a feeling that there is a constant fullness in the anal area. These are symptoms of many benign diseases but also the symptoms of anal cancer. We have to have a plan based on what is known and what evaluations are available.

Read the rest.



[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Saving Lives From Anal Cancer

via New York Times, by Roni Caryn Rabin

Paulette Crowther’s three children were grown and she was plotting a midlife career change when a routine colonoscopy picked up cancer, but not of the colon — of the anus.

The diagnosis was a shock. Ms. Crowther, a 51-year-old mother of three from New York City, had had no symptoms and was feeling just fine. It felt like a bolt from the blue. The cancer had already spread.

But as Ms. Crowther and her children scoured the Internet for information, they couldn’t help but wonder whether the cancer could have been prevented, or caught earlier at least.

Some 80 to 90 percent of anal cancers are caused by the human papillomavirus, or HPV, the same kind of virus that causes cervical cancer. And decades earlier, when Ms. Crowther was in her 20s, she had been treated for cervical dysplasia, a condition that often precedes cervical cancer – and is also caused by an HPV infection.

If only she had known.

“We think Mom could have been saved if she’d been monitored and screened more often,” said Ms. Crowther’s oldest child, Justine Almada, 27. “Studies show that if you have cervical dysplasia, you’re at higher risk. At the very least, she should have been made aware of that.”

She added, “Anal cancer is quite treatable if it’s found early.”

The same types of human papillomavirus implicated in cervical cancer, HPV 16 and 18, are also linked to anal cancer. And in December, the Food and Drug Administration expanded the approved uses of the HPV vaccine Gardasil to include prevention of anal cancer and precancerous lesions.

Ms. Crowther — who was fiercely devoted to the brood she raised in Lower Manhattan, largely on her own after a divorce, and whom the children call their “best friend” — died last April. Within three months, Justine and her siblings, Tristan and Camille Almada, ages 25 and 23, had established the HPV and Anal Cancer Foundation.

The foundation’s aim is to raise awareness about the link between the human papillomavirus, an incredibly common sexually transmitted infection, and a whole list of cancers, each of which affects a relatively small number of people but which, taken together, affect tens of thousands. Besides anal cancer, HPV infections are linked to some gynecological cancers, like vulvar and vaginal cancers, certain penile cancers in men and certain head and neck cancers.

With a robust Web site — analcancerfoundation.org — and an expert scientific advisory board, the organization also aims to increase awareness about preventive screening, provide support to family members and caregivers and raise money for research on treatment, which remains limited for metastatic disease.

“What keeps us going is the thought that if someone had done this already, it could have prevented what happened to Mom,” said Camille, who recently stepped in to run the tax-exempt foundation.

The irony is that while Ms. Crowther was still alive, she never told anyone what kind of cancer she had. Experts say that’s not unusual for people with anal cancer, who often are ashamed of their disease. “The assumption most people make is that if you have anal cancer, you had anal sex,” Camille said. “That’s not true. Heterosexual men also have HPV in their anus, because HPV is so prevalent. But also: who cares if you had anal sex?”

Read the rest.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

FDA approves Gardasil to prevent anal cancer [Dec 22]

Read the press release from the FDA.

The U.S. Food and Drug Administration today [December 22] approved the vaccine Gardasil for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years.

Click here for the Gay Men's Health Crisis press release on Gardasil for men.
 

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

FDA Panel Recommends HPV Vaccine to Prevent Anal Cancer

via Medscape, by Emma Hitt, PhD

Human papillomavirus (HPV) quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant (Gardasil; Merck), was recommended for an expanded indication — prevention of anal cancer in males and females ages 9 through 26 years — at a US Food and Drug Administration (FDA) advisory panel meeting yesterday.

The FDA's Vaccines and Related Biological Products Advisory Committee mulled over the recent data to consider the expanded indication.

Panelists were asked to comment on 2 discussion topics: the strength of the data to support an indication for the prevention of anal intraepithelial neoplasia (AIN) and anal cancer in males and the scientific rationale for extrapolating efficacy in the prevention of AIN and anal cancer to females.

Read the rest

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Imiquimod a good treatment for pre-cancerous anal lesions in men with HIV

via Aidsmap, by Michael Carter

HIV treatment centres should screen and treat pre-cancerous anal lesions, UK investigators argue in the online edition of AIDS. They were prompted to make this suggestion by research showing that treatment with imiquimod cream resolved or downgraded high-grade pre-cancerous anal lesions in 61% of HIV-positive gay men.

Although the investigators do not claim that imiquimod will prevent anal cancer, “we at least know that high grade anal intraepithelial neoplasia [HG-AIN, pre-cancerous lesions] can be cured. This is certainly not going to prevent all anal cancers, but it would be a grave error to await the outcome of long-term natural history studies…the time has come for all HIV centres to begin screening for and treating AIN.”

Rates of anal cancer are increasing in patients with HIV. Before the cancer develops pre-cancerous lesions develop in the anal canal.

Read the rest.

Study: Aldara Treatment Helps Clear High-Grade Anal Lesions

via AIDSmeds

Long-term treatment with a topical immune-stimulating cream called Aldara (imiquimod), approved for the treatment of external genital warts, may also improve or clear high-grade lesions inside the anuses of men living with HIV and may potentially reduce the risk of cancer. This is the conclusion of a study published online August 19 in the journal AIDS.

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Pre-cancerous cell changes sometimes 'hidden' in anal warts of gay men

via Aidsmap, by Michael Carter

Cancerous or “high-grade” pre-cancerous cells changes were detected in a high proportion of anal warts surgically removed from gay men, US investigators report in the July 1^st edition of Clinical Infectious Diseases.

The investigators believe that their findings could have implications for the management of anal warts.

Read the rest.

New Fleet enema for health, cleanliness

via Joe.My.God

“We’ve always known that some of our consumers were using Fleet enemas for reasons other than to relieve constipation, so we wanted to develop a product that would meet the needs of those users and provide them with a safe way to cleanse and frequently if desired,” [Fleet brand manager Emily] Klopp said. Fleet sells about $30 million in enemas annually and dominates the market, Klopp said. It’s unclear the exact size of the market because Wal-Mart and other stores sell private-label brands and do not disclose their sales. The new version hits shelves at CVS drug stores and Target this month, followed by Walgreens next month and Rite-Aid in June. Wal-Mart is the only major retailer so far to balk at carrying it, Klopp said.

Read the whole post.

Phase III Data Released on Gardasil and Anal Disease among MSM

via Merck Press Release

In Phase III Data Merck's GARDASIL® Was Efficacious Against Anal Disease Caused by HPV 6,11,16, and 18

Merck & Co., Inc. announced [February 17] that in new Phase III data, GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] was 77.5 percent (95 percent CI: 39.6, 93.3) efficacious against anal intraepithelial neoplasia (AIN) associated with human papillomavirus (HPV) types 6, 11, 16 and 18 in 16-to-26 year-old men who have sex with men. The data were presented at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) conference in Monte Carlo, Monaco.

“We are excited to learn more about the potential of GARDASIL to help prevent HPV and HPV-related cancers and diseases in both men and women,” said Richard M. Haupt, M.D., MPH, executive director, Merck Research Laboratories.

GARDASIL is approved in the U.S. for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar and vaginal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18. GARDASIL is also approved in the U.S. for use in boys and men ages 9 through 26 years of age for the prevention of genital warts (condylomata acuminata) caused by HPV types 6 and 11.

It is estimated that HPV types 16 and 18 account for 70 percent of cervical and vaginal cancer cases, and up to 50 percent of vulvar cancer cases and 85 percent of anal cancer cases. Types 6 and 11 cause approximately 90 percent of all genital warts cases.

The ability of GARDASIL to prevent HPV 6, 11, 16 and 18-AIN and anal cancer in males was evaluated in a randomized, double-blind, placebo-controlled trial. A total of 598 16- to 26- year old men who have sex with men received at least one dose of GARDASIL or placebo at the time of enrollment, and then again at two and six months.

This evaluation of efficacy of GARDASIL against HPV-related anal disease was conducted in a population of men having sex with men because of the known high risk of anal infection that occurs in this group.

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Anal cancer prevention in HIV-positive men and women

Abstract - Current Opinion in Oncology, September 2009
by Joel M. Palefsky
Department of Medicine, University of California, San Francisco, San Francisco, California

Purpose of review:
The incidence of human papillomavirus-associated anal cancer is unacceptably high among HIV-positive men who have sex with men, and possibly in HIV-positive women. Unlike most other malignancies occurring in the HIV-positive population, anal cancer is potentially preventable, using methods similar to those used to prevent cervical cancer in women. This review discusses the issues around screening to prevent anal cancer.

Recent findings:
Recent studies show that the incidence of anal cancer has increased since the introduction of highly active antiretroviral therapy in this population and now exceeds the highest incidence of cervical cancer among women reported anywhere in the world.

Summary:
The high incidence of anal cancer among HIV-positive individuals must not be ignored, since it may be preventable. Given the current evidence and analogy with the cervical cancer prevention model, many clinicians believe that identification and treatment of high-grade anal intraepithelial neoplasia to prevent anal cancer are warranted. When the expertise to do so exists, this is a reasonable approach, particularly if coupled with efforts to optimize further screening and treatment approaches, as well as efforts to document the efficacy of high-grade anal intraepithelial neoplasia treatment to reduce the incidence of anal cancer.

Read more on this topic on the IRMA blog.
Key word:
Anal cancer
HPV