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Stakeholder Opinions: Sexually Transmitted Infections - The Silent MenacePublished by: Datamonitor Published: Nov. 30, 2005 - 118 Pages Table of ContentsTABLE OF CONTENTS CHAPTER 1 EXECUTIVE SUMMARY 3 Introduction 3 Scope and coverage of the report 3 Datamonitor Insight into the Sexually Transmitted Infections market 4 Sexually Transmitted Infections are widespread on a global scale, affecting several hundred million individuals every year. For example, chlamydia, the most common STI, is estimated to cause up to 100 million new infections per year, while the human papillomavirus (HPV), the most abundant sexually transmitted viral pathogen, causes over 500,000 annual cases of cervical cancer. 5 STIs predominantly affect individuals who engage in high-risk sexual behavior, comprising frequent change of sexual partners, multiple partners and unprotected sex. Thus, the peak incidence of most common STIs occurs in those aged 16-24 years, with the exception of syphilis, which affects older strata of the population in particular the MSM group. 6 In addition to potentially causing symptomatic disease following the primary infection, if left untreated, STIs can further lead to the development of severe complications. These include infertility in both sexes, while pregnant women can additionally pass on the infection prior to or during delivery, which may lead to sequelae such as blindness or lung damage in the newborn child. Moreover, increasing evidence supports a tight epidemiological link between STIs and HIV. 7 While bacterial and parasitic STIs can be cured with antibiotic therapy, viral STIs can be effectively managed but not eradicated. Consequently, there is little financial incentive for the development of post-exposure therapies for both bacterial and viral STIs. Therefore, current STI R&D activity focuses on the development of prophylactic vaccines for HSV-2 and HPV infection. However, the current political and social climate notably the controversy surrounding the use of STIs vaccines in young girls might initially hinder the uptake of any prophylactic STI vaccine. 8 Key metrics 10 CHAPTER 2 SEXUALLY TRANSMITTED INFECTIONS: AN OVERVIEW 21 Overview of common STIs 21 Epidemiological trends 22 The asymptomatic nature of STIs leads to underreporting 22 STI incidence is widespread 23 Most STIs increase the risk for acquisition and transmission of HIV 26 16- to 24-year old people and MSM are at highest risk of infection, while pregnant women are at highest risk for complications 27 Incidence and consequences of STIs differ between men and women 32 Disease management 34 Most patients are identified when they present with symptomatic disease, but these are a minority of those infected 34 The goal of therapy depends on the nature of the infecting agent 36 Bacterial and parasitic STIs can be cured with antibiotic therapy 36 The focus for viral STIs is on the development of preventative vaccination, as current therapies fail to eradicate the underlying infection 38 The benefits of preventative vaccination are best reflected by the dramatic effect of hepatitis B vaccination in reducing the hepatitis B incidence 39 Resistance to therapy currently affects mainly gonorrhea 40 The STI pipeline is scarce, mainly due to low unmet needs 41 CHAPTER 3 CHLAMYDIA 45 Disease overview 45 Etiology and epidemiology 45 Chlamydia causes various diseases, the most common being the STI caused by Chlamydia trachomatis 45 Chlamydia is the most common STI worldwide 45 Disease progression and clinical manifestations 47 In women, chlamydia is the most common reason for infertility and ectopic pregnancies 47 Pelvic inflammatory disease is predominantly caused by chlamydia and gonorrhea 49 Disease management 50 Chlamydia can be effectively managed with curative antibiotic therapy 50 Prevention focuses on low-risk sexual behavior 50 Chlamydia diagnosis remains sub-optimal 50 Chlamydia can be cured with single-dose azithromycin 51 Future market outlook 53 CHAPTER 4 GONORRHEA 54 Disease overview 54 Etiology and epidemiology 54 In the West, gonorrhea is commonly caused by genitourinary exposure 54 The second most common STI affects predominantly men 54 Disease progression and clinical manifestations 58 Untreated gonorrhea can lead to a range of complications in adults and to blindness in the newborn child 58 Disease management 60 Increasing resistance has been changing prescription practices 60 Prevention focuses on low-risk sexual behavior, although microbicides are currently being evaluated in the clinic 60 Three types of laboratory tests allow for correct gonorrhea diagnosis 60 The gold standard of gonorrhea treatment is single-dose antibiotic therapy 61 Increasing gonococcal resistance, especially to fluoroquinolones, has led to the preferred use of third-generation cephalosporins 63 Future market outlook 65 CHAPTER 5 GENITAL HERPES 66 Disease overview 66 Etiology and epidemiology 66 Traditionally caused by HSV-2, genital herpes is now increasingly being caused by HSV-1 66 HSV is a ubiquitous disease and most commonly affects women 67 Disease progression and clinical manifestations 68 Following the primary infection, patients with genital herpes often suffer from recurrent disease episodes 68 Disease management 70 With curative antiherpes therapy representing an unrealistic goal, HSV R&D focuses on the development of a prophylactic vaccine 70 Partial prevention of HSV-2 transmission is currently achieved with Valtrex, while GSK’s prophylactic HSV-2 vaccine Simplirix might prevent infection in the future 70 Sensitive methods allow for effective diagnosis 70 Antiviral therapy effectively controls, but does not cure, HSV infection 71 Valtrex (valacyclovir) is the current HSV market leader 73 Future market outlook 76 2009: a blockbuster dies, a vaccine is born 76 Valtrex’s and Famvir’s patent expiries in the US are expected to lead to loss of value from 2009 onwards 76 GSK’s Simplirix protects HSV-seronegative women from HSV-2 infection 77 Two therapeutic HSV-2 vaccines have recently entered Phase I clinical trial 80 CHAPTER 6 GENITAL WARTS 83 Disease overview 83 Etiology and epidemiology 83 HPVs are a large family of viruses associated primarily with benign warts 83 HPV warts are the most common viral STI 85 Disease progression and clinical manifestations 88 Although most HPV infections are benign, infection with high-risk HPV types can lead to the development of cervical cancer 88 Disease management 90 HPV cannot be cured, but a prophylactic vaccine might soon reduce the incidence of cervical cancer 90 2006 is likely to witness the launch of a first-in-class prophylactic HPV vaccine 90 A combination of methods is used for the diagnosis of genital warts, HPV DNA and cervical cell abnormalities 90 Treatment is not curative and consists in the destruction of warts 91 Future market outlook 92 The future lies in prevention through vaccination 92 Merck and GSK are currently developing preventative HPV vaccines 92 Gardasil versus Cervarix 95 Issues associated with STI vaccination 96 HPV vaccine market potential 99 CHAPTER 7 SYPHILIS 102 Disease overview 102 Etiology and epidemiology 102 The great imitator 102 Recent outbreaks have led to an increase in syphilis cases, in particular in men who have sex with men (MSM) 102 Disease progression and clinical manifestations 106 Left untreated, late stages of syphilis can progress to cardiovascular and CNS disease 106 Disease management 108 If detected early, syphilis can be cured 108 Prevention relies on low-risk sexual behavior 108 Diagnosis is achieved through serology and microscopy 108 Penicillin G is the gold-standard cure for syphilis 109 APPENDIX A 111 Bibliography 111 Journals 111 Epidemiology 112 Fact sheets 112 Press releases 113 Datamonitor reports 113 Websites 114 Miscellaneous 114 Report methodology 115 About Datamonitor 116 About Datamonitor Healthcare 116 About the Infectious Disease analysis team 117 Disclaimer 118 AbstractIntroductionThe global incidence of STIs is estimated at several hundreds of millions cases per year, and due to the asymptomatic nature of most infections, underreporting is likely to mask the real incidence. Most STIs can lead to severe sequelae, including infertility in both men and women. While bacterial STIs can be cured, viral STIs are managed through treatment of symptomatic disease. Scope Overview of common Sexually Transmitted Infections including epidemiological trends, risk groups and factors, disease management and R&D focus. Comprehensive overviews of five common STIs, including clarification of key issues by international opinion leaders. Comparative analysis of bacterial versus viral STIs in particular with regards to disease management and goals of current therapy. Developmental and strategic analysis of preventative genital herpes and HPV vaccines in late-stage clinical development. Highlights Chlamydia, one of the most common bacterial STIs, causes up to 50% of cases of pelvic inflammatory disease (PID), a chronic infection of the female reproductive organs. Consequences of PID are ectopic pregnancies and infertility. Chlamydia and other STIs can further lead to severe sequelae in men, and also in babies born to infected mothers. Considerable evidence suggests that STIs significantly enhance the acquisition and transmission of HIV. This is thought to be the result of biological but also behavioral factors, notably the effect of antiretroviral therapy on the quality of life of HIV patients. STI awareness campaigns should leverage from the tight link between STIs and HIV. Despite the health and economic benefits of prophylaxis for viral STIs, there is considerable opposition to the introduction of widespread vaccination of young girls on grounds that this might lead to early initiation of sexual activity. Effective positioning of an STI vaccine might therefore prove a challenging task. Reasons to Purchase Understand the epidemiological drivers of five common bacterial and viral STIs and assess the untapped patient potential offered by each. Elaborate successful positioning strategies for STI vaccines, taking into consideration potential social objections to mass vaccination programs. Develop successful STI awareness and education campaigns by leveraging the tight link between STIs and HIV. Get Full Details About This Report >> |
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