Papilloma

RESEARCH TRIANGLE PARK, NC - A newly published study in the June 22, 2006 issue of the New England Journal of Medicine shows that use of condoms helps protect against human papillomavirus (HPV) infection, further substantiating condoms' usefulness in preventing most sexually transmitted infections, say two reproductive health experts at Family Health International (FHI) in an accompanying commentary.

In what officials called a major public health breakthrough, the Food and Drug Administration yesterday approved the first vaccine developed to protect women against cervical cancer.

A breakthrough might have been achieved with the recent acquisition of a vaccine for cervical cancer in women.

The Medicines Control Council has been urged to fast-track approval of Gardasil, the first vaccine against cervical cancer. The appeal came from the head of the South African subsidiary of Merck, the pharmaceutical company which late last year announced research results that pointed to the astonishing efficacy of the vaccine.

CHICAGO (AP) Low-income American women and women in developing countries who are tested for cervical cancer could benefit from faster, more aggressive treatment, two studies suggest.

Columbia-led study of nearly 7,000 women overcomes traditional barriers to more expensive, cumbersome pap tests for highly preventable & treatable cancer.

A new vaccine that protects against cervical cancer has set up a clash between health advocates who want to use the shots aggressively to prevent thousands of malignancies and social conservatives who say immunizing teenagers could encourage sexual activity. Although the vaccine will not become available until next year at the earliest, activists on both sides have begun maneuvering to influence how widely the immunizations will be employed.

HIV-positive women are four times more likely to have abnormal cervical cells than HIV-negative women, according to a US study involving over 1,000 patients published in the July 1st 2003 edition of the Journal of Infectious Diseases. The study also found that in HIV-positive women with a CD4 cell count below 500 cells/mm3 and with human papilloma virus (HPV) infection, abnormal cervical cells are much more likely to be pre-cancerous, and that treatment with HAART was does not promote disease regression. Cervical squamous intraepithelial lesions (SILs) are the most common gynaecological symptom of HIV-infection. HPV infection has been shown to increase the risk of SILs. People with immunosuppression caused by HIV, appear to be more vulnerable to HPV infection, the reactivation of HPV, and the inability of the immune system to clear the infection, leading to increased risk of cervical dysplasia and cancer. Investigators involved in the US HIV Epidemiology Research Study (HERS), a multicentre, longitudinal study wished to establish the incidence of SILs in HIV-positive women, and to compare it to that seen in a control population of HIV-negative women at high risk of HIV infection. The investigators also wished to see how SILs progressed in both HIV-positive and HIV-negative women and establish factors involved in either the progression or regression of lesions. Data from 774 HIV-positive women and 391 HIV-negative women were analysed in the course of the study. The women were aged between 16-65 and had comparable demographic backgrounds. Follow-up was for an average of four years between 1993 and 1999. At baseline, 134 HIV-positive and 18 HIV-negative women had Pap smears which suggested SILs. By the time of the first follow-up visit 145 (19%) of HIV-positive women and 18 (5%) of HIV-negative women had SILs. By the end of the study, 224 (35%) of HIV-positive women and 34 (9%) of HIV-negative women had had a Pap test indicating SILs. The incidence rate of SILs in HIV-positive women was 11.5 cases per 100 patient years compared to 2.6 cases per 100 patient years in the HIV-negative women. High-grade lesions developed in 47 (7%) of HIV-positive women during follow-up compared to four (1%) of HIV-negative women. Risk factors for SILs in HIV-positive women were CD4 cell count of below 500 cells/mm3, and HPV infection. HIV viral load was not found to be significantly associated with the risk of SILs. Investigators also found that treatment with HAART did not appear to have a protective effect against the development of SILs. Progression of SILs to high-grade lesions was associated with a CD4 cell count below 200 cells/mm3 (2.17, 95% CI, 1.44-3.28, p<.001), and to a lesser extent a CD4 cell count between 200 and 500 cells/mm3 (1.63, 95% CI, 1.11 – 2.39, p=.013). Infection with strains of HPV also increased the likelihood of SILs progressing to high-grade lesions. Unsurprisingly, HPV strains associated with an increased risk of high-grade lesions had the highest risk ratio of progression (21.48, 95% CI, 12.95 – 35.64, p<.001). Neither HIV viral load nor treatment with HAART had an impact on the chances of progression. HIV-positive women with a CD4 cell count below 500 cells/mm3 (CD4 cell count below 200 cells/mm3 0.97 95% CI, 0.55-1.70, p=.91; CD4 cell counts 200 – 500 cells/mm3 0.89 95% CI, 0.54 – 1.47, p=.65) were less likely to experience an improvement in SILs. In addition, investigators found that the chances of regression decreased with every log increase in HIV viral load (0.78 95% CI, 0.65 – 0.94, p=.009). Women who received treatment with HAART (0.86 95% CI, 0.50 – 1.47, p=.57) were no more likely to experience regression than those who received either sub-optimal antiretroviral therapy (0.95 95% CI, 0.67 – 1.36, p=.78) or no anti-HIV treatments. The investigators conclude that HIV-positive women “had higher risk of cervical SILs, including high-grade SILs, than did HIV-negative women, with more than one-third of HIV-seropositive participants developing SILs during follow-up.” They also suggest that HPV may increase the risk of SILs in HIV-positive women by interacting with HIV infection at a molecular level. The investigators also note that HAART was not associated with a decreased risk of SILs or with regression. However, they emphasise the observational nature of their study “which was not ideal for evaluating the impact of HAART on the natural history of cervical dysplasia.” The study ends with a call for the development of “innovative and cost effective methods of screening for and treating SILs in the growing numbers of HIV-infected women living longer lives.” (Source: http://www.aidsmap.com/news/newsdisplay2.asp?newsId=2131 24 June ,2003).

A local biotechnology company is the first to offer women a do-it-yourself home test that can detect cervical cancer before it starts and is more accurate than the Pap smear. Studies have shown that 70%-95% of SA women do not go for regular Pap smears and that most would prefer to self-sample in their own homes. It was this that led to the development of Sen-C-Test by a group of Pretoria-based microbiologists. Early screening for cervical cancer is vital since it is the most common cancer found in women from developing countries: one in 41 SA women is likely to develop the disease. Cervical cancer is the only cancer to be almost exclusively caused by a virus - the human papilloma virus (HPV) - a sexually transmitted disease present in 99,8% of cervical cancer cases. Unlike the Pap smear, which is a reactive test that looks for abnormal cells that are already in cancerous or pre-cancerous stages, the Sen-C-Test is a proactive test for the presence of high-risk strains of the HP virus. Studies show that 15%-20% of Pap smears produce false negatives in that they fail to detect cell abnormalities. The HPV test misses the presence of the virus in only 2% of cases. Jonathan Keytel, operations director for Glue Health, the company that developed Sen-C-Test, said that although a positive HPV test did not mean that a woman would definitely develop cervical cancer, it did determine who was at high risk and was an indicator that further testing was necessary to detect cervical changes. Testing directly for HPV represented an improvement, not a replacement for the Pap smear, and one that would enable better clinical decisions and optimal treatment. The test is made up of two parts: the self-sampling test kit and a laboratory test which uses imported DNA detection technology. Neither is new. Glue Health's innovation is in bringing two tried and tested technologies together in this unique application. Because it uses self-sampling technology, the Sen-C-Test couldresult in many more women being screened, initiating treatment earlier andb eating the cancer. But the test is expensive at R30 for the home test kitand R358,50 for the laboratory test. The high cost is a factor of the imported DNA detection technology used. The company has patented its application of the technology and aims to begin marketing it internationally next year. It is marketed and distributed locally by Aspen Pharmacare. (Source: The Financial Mail, 11 April, 2003).