Virus World

The U.S. Food and Drug Administration has approved a kit that will allow women to collect their own vaginal sample for HPV screening, a move that could increase early detection in those at risk for cervical cancer. Women will be able to swab themselves in privacy at a doctor's office, clinic or pharmacy, and the sample will then be sent off for analysis. More than half of U.S. women diagnosed with cervical cancer have never been screened or screened only infrequently for the virus, the kit's maker Roche said in a news release announcing the approval on May 15 2024. "With vaccinations, innovative diagnostic tools and screening programs, achieving the WHO's goal of eliminating cervical cancer by 2030 is within reach," Roche Diagnostics CEO Matt Sause said. "Our HPV self-collection solution helps support this goal by reducing barriers and providing access to HPV screening by allowing people to privately collect their own sample for HPV testing." Each year, about 11,500 U.S. women are diagnosed with cervical cancer and about 4,000 women die from it, according to the U.S. Centers for Disease Control and Prevention. HPV is the known cause of more than 95% of cervical cancers, Roche added. "Almost all cervical cancers are caused by persistent infection with certain types of HPV," Dr. Karen Knudsen, CEO of the American Cancer Society (ACS), said in a statement. "Self-collection can expand access to screening and reduces barriers, which will give more people the opportunity to detect, treat and ultimately survive cancer."

Most primary care doctors don't test for HPV. Instead, women are most often screened by gynecologists during a pelvic exam, a procedure to which some don't have access and others find too intrusive and embarrassing. "Roche's self-collection solution can help reduce these barriers by offering an alternative to clinician collection procedures, while also providing accurate and reliable results," Roche said. The HPV test itself is already covered by private insurance, Medicare and Medicaid, Roche told the Washington Post. "This literally just opens up another option for a different demographic of people that might not feel comfortable, that might not have access [and] may not have time" to get tested otherwise, Irene Aninye, chief science officer for the Society for Women's Health Research, told the Post. The ACS recommends that cervical cancer screening begin at age 25, and that women ages 25 to 65 have an HPV test every five years.

Studies done for the past two decades have found that self-collection for HPV testing is feasible and acceptable, and that women can collect samples as well as their physicians, the ACS said. "Self-collection was not FDA-approved at the time our current guideline was released, but we now expect a minor update to the guideline to note that primary HPV testing via clinician-collected sample or self-collection is acceptable," said ACS Chief Scientific Officer Dr. William Dahut. "We anticipate self-collection will play an increasingly prominent role in cervical cancer screening once regulatory and clinical prerequisites are in place and as supporting evidence continues to accumulate," Dahut added. The approval could also open the door for at-home collection of samples. Teal Health received FDA breakthrough designation last week for an at-home cervical cancer screening device called the Teal Wand. Women would collect their own sample at home, then send it to a lab to be tested for HPV. The designation grants Teal Health priority status from regulators when clinical trials wrap up and the data is submitted to the FDA. "No more stirrups, no more speculum," the Teal Health website promises. "The Teal Wand replaces the need for an in-office pap smear using stirrups, a speculum and a hard plastic brush or broom. With self-collect, you are in control."

Roche's Press release (May 14, 2024):

https://www.roche.com/media/releases/med-cor-2024-05-15 

In a recent study published in the journal Scientific Reports, researchers used a nationwide case-control study of Taiwanese residents to investigate the association between human papillomavirus (HPV) and thyroid cancer. Analyses of the 3,062 thyroid cancer patients and 9,186 healthy controls revealed that individuals with a prior HPV infection had more than double the likelihood of developing thyroid cancer than those without the infection (odds ratios 2.199 for HPV patients). This research presents the first concrete evidence of a carcinogen for thyroid cancer, the most common endocrine cancer and a growing concern worldwide.

The first generation HPV vaccine cut cervical cancer rates among women by 87%, British researchers reported.  The study published Wednesday in the journal The Lancet estimates that by mid-2019, there were 450 fewer cases of cervical cancer and 17,200 fewer cases of pre-cancers than expected in the vaccinated population. Researchers at Kings College London and the British government looked at population-based cancer registry data in the UK between January 2006 and June 2019 for seven groups of women, comparing those who were vaccinated to those who were not. They were looking at data covering the Cervarix vaccine, which protects against two strains of cancer-causing human papillomavirus or HPV. Newer vaccines sold under the Gardasil brand protect against even more strains of cancer causing viruses.  Of the three groups that were vaccinated, each were vaccinated at different ages. One group was vaccinated at age 12-13, another at 14-16, and another at 16 -18. Those vaccinated at the earliest ages were the most protected, the team reported. Those who got the shot between the ages of 14 and 16 saw an 62% reduced rate, and rates were reduced by 24% among those vaccinated between 16 and 18. "This study provides the first direct evidence of the impact of the UK HPV vaccination campaign on cervical cancer incidence, showing a large reduction in cervical cancer rates in vaccinated cohorts," study co-author Dr. Kate Soldan from the UK Health Security Agency said.

No cervical cancer cases were detected in Scotland in women born between 1988-1996 and fully vaccinated against HPV between ages 12 to 13, study says. A historic new study out of Scotland shows the real-world impact of vaccines against the human papillomavirus: The country has detected no cases of cervical cancer in women born between 1988-1996 who were fully vaccinated against HPV between the ages of 12 and 13. Many previous studies have shown that HPV vaccines are extremely effective in preventing cervical cancer. But the study, published on Monday in the Journal of the National Cancer Institute, is the first to monitor a national cohort of women over such a long time period and find no occurrence of cervical cancer.

“The study is super exciting. It shows that the vaccine is extremely effective,” said Kathleen Schmeler, a professor of gynecologic oncology at the University of Texas MD Anderson Cancer Center, who was not involved in the research. “It’s obviously early. We’re just starting to see the first data of the impact of the vaccine because it takes so long from the time of the vaccine to the effects.” The results underscore the importance of working to increase uptake of the HPV vaccine in the U.S., said Schmeler. Scotland, for example, introduced routine immunization in schools in 2008, and close to 90% of students in their fourth year of secondary school (equivalent to 10th grade in the U.S.) in the 2022-2023 school year had received at least one dose of the vaccine. In the U.S., where HPV vaccines are not administered in school, uptake among adolescents ages 13 to 17 is a little over 60%....

Study available here (jan. 22, 2024):

https://doi.org/10.1093/jnci/djad263

Experts said the figures show men are an 'important reservoi. r' for HPV, and should be included in control strategies. One in five men worldwide are infected with a potentially cancerous form of HPV, researchers have found. According to an analysis published in the Lancet Global Health journal, 21 per cent of men aged 15 and over are infected with at least one of the high-risk, potentially cancerous forms of HPV, or human papillomavirus – a family of more than 200 related viruses. In response to the findings, the World Health Organisation (WHO) said that more must be done to include men in global strategies to both reduce the risk for men and curb the spread of infection. While the majority of HPV cases are asymptomatic and resolve on their own, the virus can cause certain types of cancer, most commonly cervical – which kills around 340,000 women every year. But it is also linked to cancers of the genital areas and head, neck, throat and mouth – some of which affect men more than women and are becoming more common. In 2018, the International Agency for Research on Cancer estimated HPV was linked to more than 69,000 cancer cases in men. While HPV’s prevalence is fairly well-documented in women, estimates on its spread in men have been limited – until now.

HPV | The facts

It’s estimated that including boys in the HPV vaccination programme will prevent almost 50,000 non-cervical cancers by 2058, including 3,433 cases of penile cancer and 21,395 cases of head, neck and throat cancer in men. Vaccinated boys will also mean girls are doubly protected: “The girls’ programme has been very successful so far, and it’s already seen an impact in men as well as women,” says Dr Mary Ramsay, head of immunisation at Public Health England. “We’re hoping by adding boys to this it will accelerate the impact of the vaccination programme, bringing rates down even more quickly. I encourage all parents of eligible boys and girls to make sure they take up the offer for this potentially life-saving vaccine. It’s important not to delay vaccination, as the vaccine may be less effective as adolescents get older." When the jabs were first offered to girls in 2008, there was a catch up programme for older girls who had missed out, but this won’t be the case for boys. “Currently boys aged 13 to 18, who will have just missed out on the jab, won’t get a catch up programme like girls did in 2008, which is a decision Cancer Research UK is quite disappointed in,” says Sophia Lowes, health information manager at the charity. “However, parents can pay privately for their sons in that age group to have the vaccination. And it’s important to remember they have some protection, because most girls in that age group are vaccinated. After the age of 18 the vaccine is less effective, because you need it before you become sexually active and are exposed to HPV.”

After a systematic review which pooled data from more than 44,000 men across 65 previous studies, researchers estimated that one in three men globally are infected with genital HPV, while one in five had a “high risk”, potentially cancerous form. Infection rates overall were high among men aged 15-19 – suggesting they are being infected soon after their first sexual activity – but peaked among those aged 25-29. Rates remained high until the age of 50. This trend differs slightly from women, in which HPV rates decline with age, bar a slight spike during the menopause.

‘Important reservoir’

The new Lancet paper concluded that men are an “important reservoir of HPV genital infection”, and urged health authorities to consider targeting men with vaccinations, which are mainly used in women to prevent infection. Margaret Harris, a spokeswoman for the WHO, added: “The global study on HPV infection among men confirms how widespread HPV infection is in the sexually active population and affects not only women but also men. It also confirms the importance of introducing HPV vaccination in all countries and vaccines in the young population between 9 and 14 years of age before the HPV infection takes place.” The vaccine HPV is highly effective, having cut cervical cancer rates in England by 87 per cent since its nationwide rollout among teenage girls in 2008. In Britain, both girls and boys in year eight are routinely offered the vaccine, but across the world women have been prioritised in the rollout of inoculations. This is partly because there have been some shortages in supply. Ms Harris told the Telegraph that men are covered by “herd protection” when women are vaccinated, and said the latest study does not change the WHO’s advice to prioritise girls. But she added the paper reiterates that, where supply allows, men should be vaccinated and included in wider HPV control strategies. According to a 2022 WHO market analysis on the availability of HPV vaccines, there is now sufficient supply to inoculate two thirds of unvaccinated girls worldwide. “The market study also indicates that while in the short term adding secondary targets including older females and boys will have to be managed carefully, in the mid- and long term sufficient vaccines will be available for countries to add secondary targets such as boys if they can afford to do so,” Ms Harries added. 

Cited research published in The Lancet Global Health (Sept. 2023):

https://doi.org/10.1016/S2214-109X(23)00305-4 

Human papillomavirus infection may increase the risk of breast carcinoma: a large-scale systemic review and meta-analysis of case-control studies found.

Breast carcinoma (BC) is a cancer with a high morbidity rate, but the mechanisms by which it develops are not completely understood. There has been speculation regarding the potential association between breast cancer and local HPV infections. Although much clinical research supports this hypothesis, some research results disprove the association. The association of HPV infection and BC was put forward by Band et al. in 1990. Band et al. reported that HPV could immortalize normal human mammary epithelial cells, and reduce their requirement on growth factors. Since 1992, an increasing number of researches have investigated the relationship between HPV infection and BC. However, the conclusions of these studies were controversial.

Here, we analyzed 37 case control studies containing 3,607 BC cases and 1,728 controls showed an increase of BC risk with human papillomavirus (HPV) positive [summary odds ratio (SOR) =6.22, 95% confidence interval 4.25 to 9.12; P=0.0002]. Subgroup analysis proved three high risk HPV types (HPV16, 18 and 33) were positively correlated to BC. As to the potential mechanism, association between HPV and BC has not been confirmed yet. We have to admit that the appearance of HPV is not sufficient to prove virus’ etiological role in BC development. 

Our meta-analysis has certain limitations. For instance, most studies included here were conducted in Asian countries. As is reported by Li et al. (49), although 32.42% of BC cases were HPV-associated in Asians, only 12.91% were in Europeans. Also, the histology types were obliged to be analyzed by subgroup. However, due to the lack of specified data on the clinical trials, we cannot perform them in this article. Thus, these limitations are likely to introduce bias. This systemic review and meta-analysis provide the evidence for HPV infection as a potential risk factor in BC, while the mechanism still needs further evaluation.

Published in Gland Surgery (October 2019) - Open access:

https://doi.org/10.21037/gs.2019.09.04