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| 2010-06-14 |
| By Alaric DeArment http://www.drugstorenews.com/%28S%28qlogby45erggdzbwrbl1a445%29%29/story.aspx?id=142375&menuid=785 COLUMBUS, Ohio (Jun. 10) The Food and Drug Administration has approved a generic version of a drug for herpes made by Roxane Labs, Roxane said Wednesday. The FDA approved Roxane?s valacyclovir hydrochloride tablets in the 500-mg and 1-g strengths. The drug, which is a version of GlaxoSmithKline's Valtrex, is used to treat genital herpes, cold sores and herpes zoster. Valacyclovir hydrochloride tablets in the 500-mg and 1-g strengths had sales of $2.13 billion in 2009, according to IMS Health. |
| 2007-08-27 |
| Teva gets OK to sell generic of Novartis drug http://www.dailyrecord.com/apps/pbcs.dll/article?AID=2007708250311 • Teva Pharmaceutical Industries, the world's biggest generic-drug company, received final approval to sell a generic version of Novartis' Famvir, a treatment for genital herpes. Teva said it won't begin selling the medicine until a U.S. judge in Newark rules on a request from Novartis, whose U.S. affiliate is based in East Hanover, to block the generic drug until a patent-infringement trial is held. A hearing is set for Sept. 5. State • Fedders Corp., the Liberty Corner-based maker of air conditioners whose North American units filed for bankruptcy Wednesday, won initial court approval for a $79 million loan from a unit of Goldman Sachs Group. The company also won permission Thursday from U.S. Bankruptcy Judge Brendan Linehan Shannon to pay employees while it reorganizes. |
| 2007-08-03 |
| Written by News-Medical http://www.news-medical.net/?id=28101 Long-term anti-herpes treatment of women infected with both HIV and HSV2, the virus that causes genital herpes, may reduce the proportion of women with detectable HIV virus in their genital secretions according to the results of a trial in Tanzania presented the International AIDS Society Conference in Sydney. A collaborative group of scientists from the London School of Hygiene and Tropical Medicine (UK), African Medical and Research Foundation (Tanzania) and National Institute for Medical Research (Tanzania), in collaboration with INSERM Unit 743 in Paris and the Institute of Tropical Medicine Antwerp, carried out the trial which was the first anywhere in the world to measure the effects of herpes treatment on HIV acquisition, as well as the long-term effects on the infectivity of people with HIV infection. Although the results for HIV-positive women taking part in the trial were promising, the findings in HIV-negative women were unclear and more data from larger trials will be needed to establish whether long-term herpes treatment can protect individuals against HIV infection. 1,305 women were recruited in small towns and roadside settlements near Mwanza in North-Western Tanzania, and asked to take the anti-herpes drug acyclovir, or a placebo, twice daily. They were followed for up to 30 months to examine the effects on the incidence of HIV infection in 821 women who were initially HIV-negative, or on markers of HIV infectivity in 484 women who were HIV-positive. In the HIV-positive group, the proportion with HIV detected in their genital secretions after six months and twelve months was 20-25% lower in those taking acyclovir. The research followed on from observational studies showing that HSV2 infection was associated with around a three-fold higher risk of HIV acquisition 1. HSV2 is a lifelong incurable viral infection, but can be effectively controlled using acyclovir or similar drug treatments. This suggests that controlling herpes might be an effective indirect method of protecting against HIV infection, but trials were needed to test whether this approach works in practice. HSV2 infection also seems to increase the infectivity of HIV-positive individuals by disrupting the genital mucosa and increasing the levels of HIV in the genital tract. Recent trials in Africa and elsewhere have shown that short-term herpes treatment for up to 3 months successfully reduced genital HIV levels 2, 3 , but further research was needed to measure long-term effects. Disappointingly, among HIV-negative women there was no overall effect of herpes treatment on the acquisition of HIV, with similar rates seen in both treatment groups. However, there was some evidence that the effect varied according to adherence with treatment. Among women who took at least 90% of their prescribed doses, the HIV rate was 42% lower in those taking acyclovir, but numbers of infections in this subgroup were small, and the difference may have been a chance finding. Lead author Dr Deborah Watson-Jones, of LSHTM and AMREF, explains: 'Persuading women to take acyclovir twice a day for two years or more, when they are basically healthy, is obviously difficult although 70% of women did manage to take at least three-quarters of their tablets. However, despite intensive counselling, we were unable in this long-term trial to maintain the very high levels of treatment adherence of over 90% reported in the shorter trials. This may explain why there was no overall effect on HIV acquisition. However our finding of a protective effect in women with the best adherence, even though not statistically significant, leaves us with hope that this could still be an effective strategy in populations where high adherence can be achieved. We need to wait for data from a larger US-funded trial next year to find out whether this approach works as an HIV prevention tool'. Whatever the results in HIV-negative women, the trial in Tanzania adds to the growing evidence that herpes treatment of HIV-positive individuals reduces their infectivity to sexual partners. The new data suggest that this effect extends for at least 6 to 12 months, and further analyses are now being carried out on specimens taken after 24 months. Data on plasma viral load will also be analysed to see whether there is any evidence that herpes treatment reduces HIV viral replication, as suggested by the results of the shorter-term trials. Work will continue on the role of herpes control as an indirect preventive measure against HIV. 'We need every tool we can find to fight the HIV epidemic in Africa', comments Professor Richard Hayes, a senior investigator on the project. 'Safer sexual behaviour is of central importance, but we also need to look at ways of cutting the risk of transmission when sexual exposure occurs. We know that male circumcision is one approach and herpes control may be another. We must also press ahead with work to develop effective vaginal microbicides and vaccines'. 'One thing that this study makes clear is that maintaining adherence to acyclovir over a long period is challenging', adds Deborah Watson-Jones. 'An effective HSV2 vaccine would obviously be a more practical way of controlling this virus, and the development of a vaccine needs to be given a higher priority'. In 2006, an estimated 4.3 million people were newly infected with HIV, of which more than two-thirds lived in sub-Saharan Africa. This high rate of new infections emphasises the need to expand the implementation of proven prevention methods, at the same time as identifying new approaches to prevention. Herpes simplex virus type-2 (HSV2) is the most common sexually transmitted infection and is the main cause of genital herpes. In some parts of sub-Saharan Africa, 70% of women are infected with HSV2 before reaching 30 years of age. HSV2 is an incurable lifelong infection which is asymptomatic for much of the time but causes occasional episodes of genital ulcers and blisters. Genital ulcers are known to be an important risk factor for HIV infection. Even when there are no symptoms, asymptomatic genital excretion of HSV2 may occur, and there is evidence that this also increases the excretion of HIV, thus enhancing the infectivity of HIV-infected individuals. The herpes virus can be targeted by specific antiviral drugs such as acyclovir, valacyclovir or famciclovir. 'Herpes suppressive therapy', where one of these drugs is taken daily over a prolonged period, is known to be effective in reducing HSV2 expression and cutting the frequency and severity of clinical episodes of herpes. Acyclovir is a relatively affordable medication, with few side effects and to which the herpes virus rarely becomes resistant. However, its effectiveness in reducing the rate of HIV infection has not been directly tested prior to this trial. In 2001, an international workshop organised by WHO, UNAIDS and LSHTM called for randomised controlled trials of HSV2 therapy to definitively establish a causal relationship between HSV2 and HIV infectivity and acquisition 4 . The first such trials to be reported looked at the effects of short-term herpes treatment (up to 3 months) in HIV-infected individuals in Burkina Faso, South Africa, Peru and Thailand. Taken together, the results showed a clear effect on HIV genital excretion and there was also evidence of an effect on HIV plasma viral load, suggesting that herpes treatment might also reduce the clinical progression of HIV infection. The trial in Tanzania is the first to look at the effects of herpes treatment on HIV acquisition in HIV-negative individuals, as well as long-term effects (up to 30 months) on HIV infectivity in HIV-positive individuals. Two trials of long-term therapy are still in progress. An NIH-funded trial in the US, Peru and Africa (HPTN039) will provide additional data on the effect of herpes suppressive therapy on HIV acquisition and will be completed in 2008. A further multi-centre trial ("Partners in Prevention"), funded by the Bill and Melinda Gates Foundation, is looking at the effect of herpes suppressive therapy in discordant couples (where one partner is HIV-infected and the other is HIV-negative). This trial is scheduled for completion in 2009. Notes on funding and sponsorship This research was sponsored by the Wellcome Trust and the UK Medical Research Council, with supplementary support from the UK Department for International Development. The Wellcome Trust was formed in 1936 and its mission is to foster and promote research in developed and developing countries with the aim of improving human and animal health. The Medical Research Council is a publicly-funded organisation dedicated to improving human health through world-class medical research. The Department for International Development funds research on HIV/AIDS through a series of 'Research Programme Consortia'. The LSHTM-based Consortium on Sexual and Reproductive Health and HIV aims to strengthen the evidence base to enable policy makers to identify and prioritise interventions that will improve reproductive and sexual health and reduce HIV incidence among economically poor populations in Africa and Asia. Footnotes/References Freeman EE, Weiss HA, Glynn JR, Cross PL, Whitworth JA, Hayes RJ. Herpes simplex virus 2 infection increases HIV acquisition in men and women: systematic review and meta-analysis of longitudinal studies. AIDS 2006; 20: 73-83. Nagot N, Ouedraogo A, Foulongne V, Konate I, Weiss HA, Vergne L, Defer M-C, Djagbare D, Sanon A, Andonaba J-B, Becquart P, Segondy M, Vallo R, Sawadogo A, Van de Perre P, Mayaud P for the ANRS 1285 Study Group. Reduction of HIV-1 RNA levels with therapy to suppress Herpes simplex virus. New Engl J Med 2007; 356: 790-9. Ouedraogo A, Nagot N, Vergne L, Konate I, Weiss HA, Defer M-C, Foulongne V, Sanon A, Andonaba J-B, Segondy M, Mayaud P, Van de Perre P. Impact of suppressive herpes therapy on genital HIV-1 RNA among women taking antiretroviral therapy: a randomized controlled trial. AIDS 2006; 20: 2305-13. World Health Organization. Herpes simplex virus type 2: programmatic and research priorities in developing countries. Report of a WHO/UNAIDS/LSHTM workshop (London, 14-16 February 2001). Document WHO/HIV AIDS/2001.05. Geneva:WHO, 2001. http://www.lshtm.ac.uk/ |
| 2007-03-04 |
| Health News Steps to guard against cold sores, reduce spread to other people The Sun News http://www.myrtlebeachonline.com/mld/myrtlebeachonline/living/home/16827308.htm?source=rss&channel=myrtlebeachonline_home If you've ever had a cold sore, you know it can be uncomfortable or even somewhat embarrassing. Cold sores are a relatively common condition: They are caused by the herpes simplex virus, and they're contagious. Cold sores are sometimes mistaken for canker sores, which are ulcers that occur inside the mouth and are not contagious. While cold sores cannot be cured or prevented, there are steps you can take to guard against them and reduce the chance of spreading them to other people. A cold sore virus can spread from moist secretions in blisters. Avoid kissing and skin contact with people with blisters. Avoid sharing items, such as utensils and towels, which can spread a present virus. Always wash your hands carefully before touching another person when you have a cold sore. Be careful when touching other parts of your body. Eyes and the genital area may be particularly susceptible to the spread of the virus. Avoid prolonged exposure to the sun. It could trigger cold sores. Apply sunblock to your lips and face to help prevent cold sores during the winter and summer. |
| 2007-02-23 |
| Ivanhoe Newswire http://www.kltv.com/global/story.asp?s=6124297 (Ivanhoe Newswire) -- It's an unexpected form of HIV prevention -- treatment for herpes. A new study from researchers in France, England, and the African nation Burkina Faso reveals women who are infected with both the genital herpes virus (HSV-2) and human immunodeficiency virus (HIV) can reduce HIV levels with anti-herpes treatment. Results show three months of anti-herpes treatment reduced the amount of HIV in the blood and in the vagina. Researchers report the findings could lead to new ways to prevent HIV and to treatments for patients with both viruses. "Our results have important potential implications for public health and clinical practice, as HSV-2 control could become a new form of HIV prevention targeting HIV-infected individuals, as well as providing clinical benefits," reports Philippe Mayaud, M.D., from the London School of Hygiene and amp; Tropical Medicine. "Importantly, an HSV vaccine that would either prevent HSV infection or diminish the clinical and sub-clinical manifestations of HSV with a similar efficacy on HIV as HSV suppressive therapy would represent a long-lasting form of HIV prevention." Researchers also found having the herpes virus increased the replication of HIV. Previous research suggested HSV-2 enhances the risk of HIV-1 by about three-fold. The new findings could help reduce the sexual transmission of HIV from infected patients to their partners because both frequency and quantity of HIV in the female genital tract are closely related to the transmission of the virus, according to researchers. According to the latest figures published in the UNAIDS/WHO 2006 AIDS Epidemic Update, in 2006 about 4.3 million people were newly infected with HIV, mostly through heterosexual intercourse. This article was reported by Ivanhoe.com, which offers Medical Alerts by e-mail every day of the week. To subscribe, click on: http://www.ivanhoe.com/newsalert/. SOURCE: The New England Journal of Medicine, 2007;356:790-9 |
| 2007-02-18 |
| Using HIV to fight herpes http://uk.gay.com/article/5336 Gus Cairns www.guscairns.com 16 February, 2007 more articles by Gus Cairns HIV and the herpes simplex virus (HSV) normally act as a deadly duo and reinforce each other’s effects: HIV negative people with herpes catch HIV more easily and HIV positive people with herpes transmit HIV more easily. However scientists have discovered that part of a protein made by HIV itself can stop HSV getting into cells, and could even form part of an anti-herpes microbicide. The tat protein is normally one of HIV’s most deadly weapons, too. Short for TransActivator of Transcription, tat is a small protein made very early on in HIV’s life cycle inside cells. It forces cells into an actively-dividing mode so that they start churning out new copies of HIV, and in fact HIV can’t replicate without it, as without tat the cell only makes incomplete viral ingredients. An Italian team is trying to make an anti-tat vaccine that will get the body to knock out this crucial weapon in HIV’s armoury. However tat is just as deadly outside cells. Floating around as a viral toxin, it attacks cells by itself, and is thought to be a major contributor to HIV-related dementia and brain impairment. It can lock on to cells, borrow into them, and get them to make chemicals that kill off other cells. However it’s just this ability to lock on to cells that means tat – or rather a non-toxic fragment of it – may act as an anti-herpes drug. Tat is 86 amino acids long – that means its protein, a folded thread-like molecule, is made out of 86 building blocks. A non-toxic fragment - just 10 or 11 of these – is used in the potential anti-herpes drug. What happens is that, as some are to HIV, certain cells in the mucous membranes are actively attractive to herpes, being covered in ‘docking’ molecules that the herpes virus likes clings to like a magnet. The tat fragment causes the cell to withdraw these molecules inside, leaving nothing for the herpes virus to stick on to. Scientists found that if they added just one more building block to the 10-molecule tat chain that isn’t found in nature – an amino acid called cysteine – it made cells much more resistant to herpes infection and also seemed to reduce the infective capabilities of herpes virus particles. Cells treated with the so-called tat-c fragment were resistant to herpes infection for at least six hours and re-treatment easily made them resistant again. Tat-c is probably too big to be an oral drug and anyway, one wants it to act at the surface of mucous membranes. So it makes an ideal microbicide candidate for herpes. This isn’t the first time the ability of virus components to pervert the processes of body chemistry have been turned into a force for good. Researchers have already used the inactivated viral shells of diseases as nasty as measles and rabies to smuggle gene products and vaccines into cells. But the herpes-blocking properties of tat-c introduces the intriguing and ironic prospect that one day a ‘combination STD microbicide’ containing a fragment of HIV’s most deadly toxin could be developed to fight HIV and herpes infection. |
| 2007-02-07 |
| Glaxo to stop Ranbaxy from launching drug http://www.hinduonnet.com/thehindu/holnus/006200702040323.htm The Hindu News Update Service New York, Feb. 4 (PTI): British pharma giant GlaxoSmithKline is seeking an injunction from a US court to prevent Ranbaxy from launching a generic version of its drug Valtrex (Valacyclovir) for herpes and shingles, pending a patent infringement lawsuit against the Indian company. Ranbaxy had received the approval of the US Food and Drug Administration (FDA) for its generic product on February one and informed Glaxo that it plans to market the product. In a statement, Glaxo said it had filed a patent infringement suit in May, 2003 against Ranbaxy contending that its generic product would infringe Glaxo's basic "composition of matter" patent for Valtrex which, the company said, expires in June 2009. The company will file the application a New Jersey federal court to block Ranbaxy from selling the product, it said. The British company said that no date for the litigation has been set so far but under the terms of an agreement between the companies, previously approved by the court, if Glaxo applies for such an injunction within 45 days, Ranbaxy will not launch its product until the court either rules on the preliminary injunction or decides the pending case. Glaxo said while several companies have applied for US approval of generic Valacyclovir, Ranbaxy is the only manufacturer to have made a direct challenge to its basic patent. The drug is used in the treatment of genital herpes, shingles and cold sores. No immediate comment was available from Ranbaxy. |
| 2007-01-30 |
| Glaxo-Affiliated Doctors to Dominate Upcoming NIH Neonatal Herpes Conference http://cspinet.org/new/200701181.html Health Groups, Prominent Physicians Call on NIH to Seek Balance and Prohibit Financial Conflicts of Interest on Guideline-Writing Panels WASHINGTON—Next month five physicians will lead sessions at a National Institutes of Allergy and Infectious Diseases (NIAID) conference that was called to write clinical practice guidelines for preventing neonatal herpes. Four of those doctors have direct financial relationships with pharmaceutical giant GlaxoSmithKline—a company which stands to gain if the conference recommends broader testing of pregnant women for herpes, since Glaxo makes the antiviral drug Valtrex. Today more than 40 physicians and scientists and more than a dozen health organizations called on the National Institutes of Health (NIH) to seek balance when it convenes guideline-writing panels, and to ensure that all panelists are free from financial conflicts of interest like those of the four Glaxo-affiliated doctors. A December 13 front-page article in The Wall Street Journal documented how Glaxo bankrolls continuing medical education sessions and physician talks aimed at promoting universal herpes screening for pregnant women. Remarkably, two of the doctors whose activities were exposed by the Journal will be among the five presenters at the upcoming February 20 NIH conference. The four presenters with ties to Glaxo are: • Dr. Anna Wald of the University of Washington has received grants and research support for her work on herpes from Glaxo and Roche, and received honoraria from Novartis, all of whom make antiviral drugs for herpes; • Dr. Zane Brown of the University of Washington gives “two to three lectures a week advocating universal herpes testing for pregnant women, earning $1,000 to $2,500 per talk,” and most of those sessions were financed by Glaxo grants to the CME providers, according to the Journal article; • Dr. Laura Riley of Harvard Medical School is secretary/treasurer of the American Herpes Foundation, a “patient advocacy” non-profit run by a for-profit medical marketing firm; its board contains no patients and its $183,000 budget in 2004 was almost entirely funded by Glaxo and Roche; and • Dr. Richard Whitley of the University of Alabama at Birmingham, who serves on the speakers bureaus for Glaxo and Novartis and serves on the board, and receives stock options and compensation from the start-up firm Fermavir, which is developing next-generation drugs aimed at the herpes family of viruses. Moreover, Dr. Whitley carried out these private sector activities while running NIAID’s Collaborative Antiviral Study Group. Obstetricians and gynecologists are sharply divided over whether all pregnant women should be tested for herpes, given that neonatal transmission of herpes is relatively rare, occurring in as few as 200 or as many as 1,250 U.S. births each year, according to sources quoted in the Journal. Articles and letters questioning universal testing, which would almost surely lead to more women being prescribed Valtrex, have recently appeared in the Lancet and leading OB/GYN journals. “Given the controversy surrounding the subject, we were surprised to see the lineup of speakers for the February 20 meeting… The lineup did not reflect the diversity of views on this subject, nor did the invitation reveal the conflicts of interest of virtually every invited presenter,” the health organizations and physicians wrote to Dr. Elias Zerhouni, director of the National Institutes of Health, Dr. Anthony Fauci, director of the NIAID, which is part of NIH, and other officials. Signatories included Lancet Editor-in-Chief Dr. Richard Horton, former New England Journal of Medicine editors Dr. Marcia Angell and Dr. Jerome P. Kassirer, the Center for Medical Consumers, Consumers Union, and the National Women’s Health Network. This isn’t the first time that NIH has convened guideline-writing panels that had members with ties to companies that stand to lose or gain from the panels’ recommendations, according to the Center for Science in the Public Interest, which organized the letter to NIH. Panels having to do with managing cholesterol, hypertension, and HIV/AIDS have all had large numbers of industry-funded researchers serving on them. “NIH shouldn’t let drug company-affiliated doctors write the rules, and it shouldn’t stack the deck to make it look like there is medical consensus on something when there’s not,” said Merrill Goozner, director of the Integrity in Science Project at CSPI, which maintains a database of industry-funded scientists. |
| 2006-12-05 |
| By Associated Press WASHINGTON (AP) - Dozens of poor and minority pregnant women were put at risk when they were given dummy pills instead of a drug believed to prevent outbreaks of genital herpes, consumer watchdogs charged Friday. The researchers defended their work, saying in part the study was to assess the uncertain risks of the drug to the women's fetuses. In the study, researchers at Parkland Hospital in Dallas gave 170 pregnant women the drug valacyclovir to see if the drug would reduce herpes outbreaks at birth. The virus can be fatal to newborns if infected during delivery. An additional 168 women from the largely indigent population the hospital serves were given dummy pills. More of those women went on to have Caesarean sections than did those given valacyclovir, which the body breaks down to form the herpes drug acyclovir. Since the researchers had published a study midway through the clinical trial that concluded giving women acyclovir could reduce the C-section rate, critics allege they needlessly put half the women at risk by not giving them the drug instead of dummy pills. ''What I don't understand is how you can do a research study and conclude that a drug is effective and then stare a bunch of pregnant women in the face and withhold the very drug you've just recommended,'' said Dr. Peter Lurie, of the watchdog group Public Citizen. Lurie and two other doctors leveled their criticism in a letter appearing this month in the journal Obstetrics & Gynecology. The journal published both the 2003 study by the researchers suggesting a benefit to treating women with acyclovir, as well a July 2006 study that concluded valacyclovir significantly reduced the outbreaks that lead to C-sections. A doctor involved in the studies, Dr. George Wendel, would not comment specifically on allegations that poor women were taken advantage of. In an interview, he said the study was designed and conducted ''according to good research practices'' and approved by the hospital's ethics review board. Wendel and his colleagues also published a rebuttal in the journal, saying in part that the study balanced the risks and benefits of valacyclovir to both the mothers and their fetuses. Clinical trials of new drugs typically compare them with dummy pills - unless there already is an effective treatment available. Wendel also said their 2003 work didn't conclude acyclovir should be recommended, only that more research was needed. Since 1999, the American College of Obstetrics and Gynecology, publisher of the journal, has recommended acyclovir treatment be considered late in pregnancy for women who suffer their first genital herpes outbreak while pregnant. Acyclovir is widely available in generic form. Valacyclovir is sold as Valtrex by GlaxoSmithKline, which sponsored the 2006 study. |
| 2006-11-17 |
| Herpes shot tested in Valley Vaccine may protect against common sexually transmitted disease by Annalyn Censky published on Tuesday, November 14, 2006 http://www.statepress.com/issues/2006/11/14/news/698832 A vaccine to prevent genital herpes is being tested on Phoenix-area women. The National Institute of Allergy and Infectious Diseases is partnering with pharmaceutical company GlaxoSmithKline Biologicals to test the new vaccine on about 7,500 women in more than 40 locations throughout the United States and Canada. Called Herpevac, the vaccine is in stage-three clinical trials. In earlier trials it was found to reduce the risk of a genital herpes infection by about 75 percent, according to NIAID. If the Food and Drug Administration approves Herpevac, ASU's Campus Health Service would seek to build a supply as soon as possible, said Interim Director and Chief of Staff Dr. Stefanie Schroeder. It's exciting, she said, particularly after the human papillomavirus vaccine was approved earlier this year. Merck and GlaxoSmithKline competed to release the HPV vaccine first, and Merck succeeded when its vaccine, called Gardasil, was approved in June. Now, GlaxoSmithKline has a leg up with the herpes vaccine - which Merck officials say their company is not pursuing. Approximately one in four adult women in the United States already has genital herpes, NIAID reported. The Campus Health Service has diagnosed 43 new cases of herpes since March, Schroeder said. Herpes is a virus, and once contracted, a patient has it for life. The only completely effective method for preventing it is abstinence, Schroeder said. While condoms help, they are not foolproof because the virus can live in the skin surrounding the genital region in addition to on the genitals, Schroeder said. Herpes is usually treated by an antiviral oral medication called Valtrex, which is also produced by GlaxoSmithKline. Now, the company is recruiting women to participate in Herpevac trials. Their recruiting efforts included ads posted on facebook.com in October. The vaccine is being tested at three facilities in the Phoenix metropolitan area. To participate in the clinical trials, women must first go through a blood screening to confirm they do not already have the herpes virus. While there are risks to participating in clinical trials, they are relatively minor, Schroeder said. "Once it goes to human trials, the risk is very small," she said. "Most of the big bugs have been worked out, but you're still taking a risk." For Rosie Servis, an English literature sophomore, the cause was worth the risk. Servis participated in Herpevac trials about four years ago. She received the shot three times over a period of about a year, and in the end had no complications. The vaccine was successful, Servis said, and she recommends other women participate as well. "Anything that can help protect women, I think is very positive," she said. Reach the reporter at: Annalyn.Censky@asu.edu |
| 2006-11-10 |
| Liquorice stops 'herpes' cancer BBC news http://news.bbc.co.uk/1/hi/health/4307907.stm A compound in liquorice may help to stop people with a herpes virus from developing cancer, research suggests. A team at New York University found the compound - glycyrrhizic acid - could stop the virus triggering a form of cancer called Kaposi sarcoma. The infection causes tumours to develop in tissues below the skin, and in internal organs. It is often found in people with a depressed immune system. The research is published in the Journal of Clinical Investigation. Many of the herpes viruses that infect people can sit latent in cells for long periods of time. But when they are reactivated, they can cause painful symptoms and distress. While treatment for active infections is progressing nicely, it remains very challenging to treat latent infections. In particular, progress in treating herpes virus latency has lagged behind. Infected cells The New York team showed that glycyrrhizic acid (GA) could kill cells that were harbouring the herpes virus associated with Kaposi sarcoma. The compound was able to disrupt the action of the key genes that control the virus' ability to stay lurking in a cell, latent, but with the potential to trigger disease. As a result, production of crucial proteins was knocked out of kilter, destroying the delicate balance between virus and cell, and leading to the death of the infected cells. The researchers say their work is the first time an anti-viral agent has been found that specifically targets genes required to maintain the virus in a latent state. They hope it could lead to the development of new drugs to combat latent viral infections. In an accompanying commentary, Dr Jeffrey Cohen, from the US National Institutes Of Health, said: "While a compound present in liquorice may seem like an unlikely candidate for the treatment of virus-associated cancers, it is important to remember that other traditional drugs have proved highly effective for some infectious diseases. "Extracts of the wormwood plant, which is a traditional Chinese medication for treatment of febrile illnesses, contain artemisinin - derivatives of this compound have become first-line treatments for drug-resistant malaria. "Thus, derivatives of GA or other traditional medicines might be used in the future for treating human diseases caused by latent virus infections." Liquorice, derived from the root of Glycyrrhiza glabra, has been used for more than 4,000 years as a flavouring agent in foods, beverages, and tobacco. It is also used as an alternative medicine for the treatment of gastric and duodenal ulcers, sore throat, bronchitis, cough, arthritis, adrenal insufficiency, and allergic diseases. |
| 2006-10-29 |
| Drugmakers criticized over release of trial data Delayed or partial disclosure of clinicals worries experts Sunday, October 29, 2006 BY ED SILVERMAN Star-Ledger Staff http://www.nj.com/ In 1998, a big pharmaceutical company completed a pair of clinical studies comparing rival drugs for treating genital herpes. But the results weren't published until last month. The unusual delay is being chalked up by one drugmaker to the complicated fallout from a merger, which caused one medicine to change hands and data to be misplaced. But the lead researcher for the studies complained she was never given a satisfactory explanation, and noted the drugmaker responsible for the delay also owns the medicine that fared poorly. "I was given all sorts of reasons," said Anna Wald, a professor of medicine at the University of Washington, whose work compar ing the two drugs -- Valtrex and Famvir -- was recently published in Sexually Transmitted Diseases, a medical journal. "It took years to receive any material," she said. "They should have moved faster." The episode comes to light amid growing criticism of the pharmaceutical industry for failing to disclose results of clinical studies -- especially studies that provide information about the safety or effectiveness of medicines being taken by consumers. The charges became especially heated during the recent debate about the safety of antide pressants and the withdrawal of the once-popular painkiller Vioxx, which spurred accusations that, in some cases, side-effect data were suppressed. The issue has prompted scru tiny from some members of Congress and calls by the editors of several leading medical journals to require greater -- and more timely -- disclosure of clinical trials. Put on the defensive, pharmaceutical companies are voluntarily register ing more of their clinical trials on company and government Web sites. The debate, however, is far from finished. Last month, a report by the Institute of Medicine, which criticized industry oversight by the Food and Drug Administration, recommended results of nearly all clinical trials should be disclosed. The report also noted few meaningful studies are conducted after a drug goes on the market, and even then, the data are generally quite limited. "The purpose in having greater disclosure is for doctors and patients to make informed choices about benefits and risks," said Bruce Psaty, a professor of medicine at the University of Washington and a member of the IOM drug safety panel that issued the report. "It's simply not appropriate to delay publication. It's not in the interest of public health." The studies of Valtrex and Famvir, for treating genital herpes, originated in the mid-1990s with the former SmithKlineBeecham, which originally sold Famvir. A rival medicine, Valtrex, was sold by the former GlaxoWellcome. The drugs were already on the market and each company touted their treatment as superior, but there was no comparative data to bolster the claims. To gain an edge, SmithKlineBeecham funded a pair of comparative studies. Such clinical trials are known as head-to-head studies, but are rarely undertaken voluntarily by drugmakers due to the expense and, in particular, the possibility that results will be unflattering. In effect, SmithKlineBeecham took a gamble in hopes of goosing sales. There was good reason. In 1997, the drugs were in a dead heat. Val trex sales totaled $111million on 1.6million prescriptions, while Famvir rang up $107million in revenue on 1.1million prescriptions, according to Verispan, a market-research firm. A team of researchers led by Wald conducted the studies in 1997 and 1998, but SmithKlineBeecham never shared the results, even though Wald said she repeatedly asked for the data. As a result, Wald said she had no way of knowing SmithKlineBeecham's Famvir compared unfavorably with Val trex. In other words, SmithKlineBee cham lost its bet. "They kept telling me they were analyzing the data and analyzing the data," she said. "I got nowhere." In 2000, Glaxo and SmithKline merged, complicating the tale. The combined company promptly sold Famvir to Novartis to satisfy anti- trust concerns. A Glaxo spokeswoman said there was no information available about how the study data were handled at that time or why the data weren't given to Wald. By then, Glaxo's Valtrex had taken the lead. In 2001, Valtrex generated $413million in sales on 4.4million prescriptions; Famvir rang up $191million in sales on 1.5million prescriptions, according to Verispan. After the merger, Wald said she began asking Novartis for the study data, but didn't receive anything until early last year, when the drug maker sent what she described as an "enormous box of papers." She said Novartis personnel insisted the data couldn't be located. "There are two possible interpretations," said Wald, who is also a consultant to Novartis. "Either the data got lost as part of the transfer from one company to another. The other is that Novartis didn't want to share the data be cause it wasn't favorable (to Famvir), which might hurt the sales. I don't know which it is." In an e-mail, a Novartis spokeswoman, Lucia Aurello-Beauchamp, wrote that there was actually no statistical significance found between the two drugs in the studies. However, Wald and her colleagues concluded in their recently published journal article that Val trex appears to be "somewhat bet ter" than Famvir. The spokeswoman added No vartis supports timely disclosure of clinical trial results and last year agreed to support an industry initiative. But she acknowledged "it took longer to publish the results than we would have wished. This reflects the fact that we did not conduct the studies ourselves, but acquired the data from another company, which had not completely analyzed the results." The Novartis spokeswoman also explained Famvir data were stored among 28,000 boxes sent by Glaxo, and that talks began with Wald in January 2003. But she couldn't ex plain the delay between 2003 and late 2005, when Wald finally received the data. One physician said he might have given patients a different medicine if the studies had been published. "We used to prescribe a lot of Famvir three to five years ago, al though we've since come to believe Valtrex is a better drug," said Ronald Frank, a urologist in Livingston. "But maybe I would've prescribed more Valtrex back then if I'd known about the studies. It's something I would've like to have known." Ed Silverman may be reached at (973) 392-1542 or esilverman@starledger.com |
| 2006-10-26 |
| Herpes increases HIV risk to tops http://uk.gay.com/article/5030 Gus Cairns www.guscairns.com 19 October, 2006 more articles by Gus Cairns Herpes infection in gay men with HIV can increase their HIV viral load, and especially increase the risk of transmitting HIV from a passive to an active anal sex partner, a new study has found. We’ve known for over two years that gay men with HIV can sometimes have much more virus up their bum than they do in their blood or their cum. One study reported on Gay.com found that gay men who weren’t on HIV treatment could have 25 times as much HIV in rectal secretions as they did in their blood and even ones on treatment had four times as much. Other studies since then have found that, intermittently at least, it can be as risky to be the active partner in unsafe sex as the passive one. Now a new study has found that ‘peaks’ of HIV virus, both in the rectum and in the blood, coincide with peaks of herpes virus production too. We’ve also known for a while that herpes – a virus that normally stays dormant but which periodically reactivates itself – increases HIV production, and a study from Africa found that HIV positive women given an anti-herpes drug and who weren’t on HIV treatment were 90% less infections with HIV , while ones who were on antiretrovirals were 75% less infectious. People often don’t get symptoms when herpes reactivates and mild rectal infections are likely to go unnoticed anyway. One study from San Francisco found that 62% of HIV positive gay men tested positive for herpes too. What’s new about the current study is that it links these two facts and suggests that treating HIV-positive gay men with an anti-herpes drug like acyclovir could contribute to HIV prevention. The study, from Peru, looked at 23 gay men with HIV and herpes, six of them recently infected with HIV. None were on HIV treatment and over half had been the passive partner in anal sex in the previous three months. All of them had HIV detectable in their blood, and all but two in rectal swabs; furthermore that average viral load was higher in the rectal swabs. The swabs indicated that herpes infection was active – meaning the men were infectious for it – a quarter of the time. During those times the HIV viral load in the rectum was 38% higher and in the blood 29% higher than at other times. “Herpes virus reactivation may increase HIV infectiousness and disease progression,” the researchers conclude. |
| 2006-10-16 |
| Single-Day Therapy Treats Herpes & Cold Sores Physician's Weekly http://www.physweekly.com/ The FDA has approved famciclovir (Famvir, Novartis Pharmaceuticals Corporation) as a single-day antiviral treatment for recurrent genital herpes and for cold sores in people with healthy immune systems. The approval was based on evidence from two clinical trials in which the agent was associated with milder symptoms and shorter duration of outbreaks when compared with placebo. Famciclovir was previously approved as a five-day treatment for genital herpes. |
| 2006-10-09 |
| Comforting Cold Sores By Sylvia Perez http://abclocal.go.com/wls/story October 4, 2006 - They are ugly, painful and they show up at the absolute worst times. Cold sores make a lot of people miserable. There is no cure but an experimental medication is offering some new hope. You might not think it's that big of a deal, but eight out of every 10 people have the virus that causes cold sores. And, if you're one of the unlucky millions, you know how desperate you can be to get rid of them. But there is no easy way. Most people just want to stop the sores from ever showing up. Researchers in Chicago say that may soon be possible. The trouble maker is a microscopic illness known as the herpes simplex one. It's not same virus that causes genital herpes. This one is often a fever blister that appears on the mouth and will eventually go away. So how do you get it? Well, most people are infected in childhood through skin to skin contact. They're tough to look at and even tougher to live with. When it happens the blisters can last from seven to 12 days. It's hard to fight this disease because the virus likes to hide or sleep deep in nerve cells. Everything from a severe cold to emotional stress can wake up or reactivate the virus and that can result in the return of the blisters. "The pain ranges from mild tingling to constant throbbing," said Paul Rowe, patient. Current treatments weren't helping much with Paul Rowe's cold sores, so he decided to join a study at Radiant Research in Chicago. Doctors there are testing a cream that may have the ability to stop the sores from ever showing up. "It's very exciting especially for sufferers of cold sores. They are going to hopefully have something that will be a new revolutionary treatment," said Dr. Jeffrey Geohas, Radiant Research. Trial participants carry the drug on a key chain so it's with them all the time. The minute they feel that tell-tale tingle they apply the cream to the area. Because the trial is on going, researchers can't tell us much about the medication.. What we do know is that it's a two drug combination. One of the medications is an anti-viral called acycolvir. It's been around for years. The other drug is designed to work on the body's immune response. "The acycloviar actually inhibits the virus. The investigational medication would block the immune response, and by working together, we are confident it's gonna shorten the duration. But it may prevent the cold sore from ever forming," said Geohas. Current treatments over-the-counter and even prescription medications can be hit or miss. Most can shorten the duration by a couple days. Famvir, which is taken in pill form, is now available in a stronger single-dose that may make it more effective. Kenneth Thompson at the University of Chicago makes drugs to fight different viruses. He believes the only sure way to stop cold sores is a vaccination. "Remember, if our own immune system can't do it when we are infected with it, you are asking a lot of a vaccine to do this. But I suspect eventually we'll find that key, so that would be number one. If you can make a vaccine, you are in business," said Kenneth Thompson, Ph.D., virologist, University of Chicago Hospitals. A government funded study testing a herpes vaccine is underway at more than 20 sites across the US. The Chicago study on the experimental cream is a phase three. That means if the medication proves to be effective and safe it could soon be approved by the FDA. That trial still needs participants. More information is available at Radiant Research's web site. Radiant Research 515 N. State St. Suite 2700 Chciago, IL 312-494-2298 |
| 2006-09-30 |
| Drug May Curb Herpes Virus Shedding Drug, Called Famvir, Studied in Patients With Herpes Simplex Virus Type 2 By Miranda Hitti WebMD Medical News Sept. 28, 2006 --The antiviral drug Famvir may curb the shedding of the herpes simplex virus type 2 (HSV-2) in some -- but not all -- genital herpes patients, a new study shows. The study was presented today in San Francisco, at the American Society for Microbiology's 46th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy. The researchers included Peter Leone, MD, of the University of North Carolina at Chapel Hill. Before you explore their study, take a moment to review these basic facts on genital herpes: * It is spread through sex. * It is most commonly caused by HSV-2. * It can also be caused by herpes simplex virus type 1 (HSV-1). At least 45 million people in the U.S. -- one in five adults and adolescents -- have carried an HSV virus, but many of them don't know it, according to the CDC. Genital herpes sores can release the herpes virus. But the virus can also be shed from skin between outbreaks, says the CDC. That is, it's possible to spread the herpes virus even if you don't have herpes sores. Herpes Study Leone and colleagues studied 129 people with evidence of HSV-2 virus infection from blood tests. Some had a history of outbreaks of genital herpes while others didn't. The researchers randomly split participants into two groups. Participants in one group took Famvir for 42 days. Then they took a two-week break. Lastly, they took pills containing no medicine (placebo) for 42 more days. Participants in the other group took the same pills in reverse order. They took the placebo first for 42 days, followed by a two-week break, and then they took Famvir for 42 days. Participants didn't know which pills were Famvir. Each participant also provided daily swabs from his or her genital area. The researchers analyzed those swabs for HSV-2. Study's Results Participants with a history of genital herpes outbreaks showed reduced HSV-2 shedding while taking Famvir, but not with the placebo. But HSV-2 shedding wasn't curbed by Famvir in people who had never had a genital herpes outbreak. Famvir therapy "suppresses HSV-2 shedding in patients with a clinical history of genital herpes," write Leone and colleagues. Leone notes financial ties to Novartis, the drug company that makes Famvir. Novartis is a WebMD sponsor. |
| 2006-09-29 |
| 'Double strength' drug fights herpes September 26, 2006 The Austrailian THE addition of a new double strength anti-viral drug to the pharmaceutical benefits scheme could help slow the spread of genital herpes, a sexual health expert said. Dr Darren Russell, the director of sexual health at Cairns Base hospital, said the Federal Government's decision to add higher strength doses of the drug famciclovir to the PBS from today would benefit the millions of Australians who carry the virus. He said sufferers could take two 500mg tablets a day instead of four 250mg tablets a day, reducing the chances of patients forgetting to take medication or taking less than the recommended dose. The higher dose pack contains one month's supply and comes with five repeats, meaning fewer doctor visits for sufferers. "People don't like taking handfuls of tablets ... we try to get the minimum number of pills each day to make it easier to take," he said. The drug boosts the immune system and helps ward off outbreaks of the virus. Dr Russell hoped the more convenient dose would help reduce transmission of the virus. "We know that with genital herpes if you reduce the amount of virus that's being shed you reduce the amount of transmission," he said. "If people take this medication properly and regularly it reduces the risk of spreading it to other people." The new drug is also good news for people with HIV, or who are undergoing chemotherapy or radiotherapy who are at a heightened risk of developing a herpes outbreak. About one in eight sexually active Australians suffer from the virus - about 12 per cent of the population. But Dr Russell said almost 70 per cent of carriers have no idea they carry the virus, do not develop the lesions associated with it but can still spread herpes onto sexual partners. He recommended sexually active adults visit a doctor for a check-up of sexually transmitted diseases at the beginning of a new relationship and use condoms. |
| 2006-09-28 |
| Famvir Only Needs to Be Taken for a Single Day to Treat Herpes and Cold Sores By Miranda Hitti WebMD Medical News Reviewed By Louise Chang, MD on Wednesday, August 02, 2006 Aug. 2, 2006 -- The FDA has approved the drug Famvir as the first and only one-day antiviral treatment for recurrent genital herpesgenital herpes and cold sorescold sores in people with healthy immune systems. The drug's maker, Novartis Pharmaceuticals Corp., announced the FDA approval in a news release dated July 28. At least 45 million people age 12 and older in the U.S. have had a genital herpesherpes infection -- or about one in five in that age range, says the CDC. Before, genital herpes required five days of Famvir treatment -- although at a lower dose. Famvir was not FDA approved for cold sores in people with healthy immune systems (meaning those without aids). The new approval shortens Famvir treatment to a single day at the start of an outbreak and adds cold sores to the drug's approved uses. Famvir Dosage Patients would take 1,000 milligrams of Famvir twice daily for one day at the first sign of genital herpes symptoms, and 1,500 milligrams of Famvir once for one day at the first sign of cold sore symptoms to shorten outbreaks and reduce symptoms. The drug, available only by prescription, is taken orally. It does not cure genital herpes or cold sores. Currently, there is no cure for herpes. Antiviral drugs such as Famvir, Zovirax and Valtrex can only help treat or suppress the infection. Famvir earned FDA approval in 1994 and is used to treat shinglesshingles, as well as the herpes virus which causes both genital herpes and cold sores. Timing Counts Single-day Famvir should be started within six hours of the first sign of symptoms, such as tingling, itching, burning, or the appearance of herpesherpes sores, says Novartis. There is "a narrow window of opportunity for treatment" at the start of an outbreak of herpes or cold sorescold sores, says Novartis. Timing is crucial because the virus copies itself most actively in an outbreak's first hours. Interrupting that process may shorten the outbreak and reduce its severity. Herpes Virus There are two types of the herpes simplex virus: herpes simplex virus 1 (HSV-1) and herpes simplex virus 2 (HSV-2). Cold sores are typically caused by the former, which can spread by kissing an infected person or sharing eating utensils, towels, or razors. Genital herpesGenital herpes is a sexually transmitted disease (STD) and is usually caused by HSV-2, although it can result from HSV-1. Most genital herpes patients have few or no symptoms, the CDC notes. When symptoms appear, there are usually one or more blistersblisters around the genitals or rectum. The blisters can break, leaving tender sores that may take several weeks to heal. Clinical Trials Single-day Famvir was tested in clinical trials for treatment of recurrent genital herpes and cold sores. The genital herpes trial included 329 patients. At the first sign of a herpes outbreak, they got one of two treatments, without knowing which they received: * 1,000 milligrams of Famvir twice daily for one day * A pill containing no medicine (placebo). The Famvir group had milder symptoms and shorter outbreaks that lasted about four days, instead of six days with the placebo, Novartis reports. Single-dose Famvir had a similar effect on the length and severity of cold sores in the cold sores trial, which included 481 patients, according to Novartis. Novartis is a WebMD sponsor. |
| 2006-09-12 |
| Home News Tribune Online 09/12/06 While getting ready for a date, Michael Twain discovered something that he thought would ruin his whole evening - a cold sore, otherwise known as oral herpes. Embarrassed, Twain decided to cancel. "I get cold sores frequently on my lips and I always feel like hiding," says Twain, who did not want to use his real name. "So, anytime I get an outbreak before a date, I cancel. I don't even know how to bring it up to people." Twain is not alone. Approximately 200 million Americans have oral herpes and 50 million have genital herpes, according to the Centers for Disease Control and Prevention. However, since herpes is not commonly discussed, many cases are not diagnosed or documented. Herpes is a highly contagious viral infection that "sleeps" in the body and can be triggered at any time. Herpes is transmitted through direct skin-to-skin contact — oral herpes most commonly through kissing, and genital herpes through sexual activity, including oral sex — but due to the fragility of the virus, neither form is transmittable from inanimate objects such as a toilet seat or towel. Both oral and genital herpes can begin with a tingling burning sensation that develops into painful red sores or lesions. "Sufferers and their partners can face great stress because becoming intimate can be difficult. The outbreaks can also cause concern and lower self-esteem," says Dr. Stephen Tyring, professor of dermatology, microbiology, molecular genetics and internal medicine at the University of Texas Health Science Center in Houston, Texas. "The problem is emotional stress and it can actually trigger additional outbreaks, so sufferers need to relax to control herpes," he says. Fatigue, hormonal changes, sickness and injuries like sun-damaged lips and cuts from shaving can also lead to outbreaks. Experts suggest plenty of rest and exercise to keep the immune system strong. Doctors are trained to discuss potentially embarrassing health issues and can conduct tests to determine if you have herpes. While there is no cure for the virus, a doctor can prescribe topical antiviral acyclovir treatments to soothe discomfort, shorten the duration of an outbreak and reduce the chances of spreading the virus. "Herpes is a common virus for millions of Americans," Tyring says. "If people understand the virus, it doesn't have to ruin relationships." |
| 2006-09-12 |
| By SHARI ROAN Los Angeles Times The Food and Drug Administration has approved two new dosing regimens for the herpes drug Famvir that, used properly, can work in a single day to prevent or curtail a herpes outbreak. The single-day dosing culminates 25 years of advances against the herpes viruses, researchers say. And the best advance may be yet to come. A vaccine that could prevent herpes in women is being studied. Three decades ago, no one could have anticipated such success against herpes. "Herpes is a difficult disease to treat. For years people said it was untreatable," says Dr. Spotswood Spruance, an infectious-diseases expert at the University of Utah. "There's a big difference between what we had in the past and the simplicity of this new treatment." An estimated 50 percent to 80 percent of Americans are infected with the herpes simplex virus type 1, which primarily causes cold sores. Most people are infected during childhood through skin-to-skin contact. HSV-1 can also cause genital infections. Herpes simplex virus type 2 primarily causes genital blisters and is sexually transmitted. About 20 percent of American adults have HSV-2. The severity of infections varies widely. Some people have no symptoms and are unaware they are infected. In those who do have obvious outbreaks, symptoms can range from severe and frequent to mild and infrequent. A pregnant woman with an active infection -- whether symptoms are apparent or not -- can transmit the virus to her baby at birth, causing serious problems such as seizures, blindness, spasticity or death. Until 1982, when the anti-viral ointment acyclovir was introduced, people with herpes simply suffered through outbreaks. Acyclovir represented a new class of drugs, called nucleosides, that block viral reproduction. Once they invade the body, herpes viruses take permanent shelter, nestling quietly in nerve cells until something -- illness, stress, sunburn or unknown factors -- causes the virus to awaken and replicate. Although these early hours of virus activity can produce symptoms such as tingling, the blisters don't form until later, providing a window to stop or limit their formation. A pill form of acyclovir was introduced in 1985. Drugs that are absorbed more effectively and require fewer doses -- Valtrex (valacyclovir) and Famvir (famciclovir) -- followed. An ointment for cold sores, Denavir (penciclovir), is also available. "This class of drugs, the nucleosides, is now the standard of care," says Dr. Stephen Tyring, a professor of dermatology at the University of Texas Health Sciences Center at Houston and the chief investigator of a study on genital herpes and single-day dosing of Famvir. Over the years, doctors have learned that the medications can be taken in higher doses for shorter periods, such as three days, particularly when started at the first sign of an outbreak. The single-day Famvir regimens are the latest approach to warding off outbreaks quickly and easily, and also provide guidelines about how soon medication must be started to prevent or curtail the blisters. For cold sores, the FDA has approved one 1,500-milligram dose (three 500-milligram tablets) that should be taken within one hour of the first sign of symptoms, such as burning, itching or tingling. For genital herpes, a 1,000-milligram dose taken twice daily for one day should be effective if taken within six hours of the first sign of an outbreak. The cold sore studies show that the single-day dose, if taken within the appropriate time frame by people with healthy immune systems, shortened outbreaks by about two days and reduced the pain and tenderness of the blisters. It did not prevent outbreaks. However, in the genital herpes study, single-day dosing prevented outbreaks in about half of the people and shortened the outbreak by about two days in the other half. It's crucial to have the medicine handy and to take it right away for the best chance of stopping an outbreak, says Spruance, the lead investigator of the cold sore study. The tingling, itching or burning sensation is a sign that the virus has become active and is replicating. Most herpes sufferers can identify those symptoms easily, he says. Doctors say not enough people obtain treatment for herpes. Even those with infrequent outbreaks should inquire about medication, experts say. Herpes can be transmitted during outbreaks and even when someone is asymptomatic. "People with mild or infrequent outbreaks are unlikely to seek medical attention," Tyring says. "But they could still spread it to someone else, or a baby could be born to a mother who has it. That is the worst-case scenario." |