Sexually Transmitted Infections

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Publication Date: 2005-11-30

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The 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

Report 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

ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Infectious Disease pharmaceutical analysis team - page 2
CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Introduction - page 3
- Scope and coverage of the report - page 3
- Datamonitor Insight into the Sexually Transmitted Infections market - page 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. - page 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. - page 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. - page 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. - page 8
  - Key metrics - page 10
CHAPTER 2 SEXUALLY TRANSMITTED INFECTIONS: AN OVERVIEW - page 21
- Overview of common STIs - page 21
  - Epidemiological trends - page 22
    - The asymptomatic nature of STIs leads to underreporting - page 22
    - STI incidence is widespread - page 23
    - Most STIs increase the risk for acquisition and transmission of HIV - page 26
    - 16- to 24-year old people and MSM are at highest risk of infection, while pregnant women are at highest risk for complications - page 27
    - Incidence and consequences of STIs differ between men and women - page 32
  - Disease management - page 34
    - Most patients are identified when they present with symptomatic disease, but these are a minority of those infected - page 34
    - The goal of therapy depends on the nature of the infecting agent - page 36
    - Bacterial and parasitic STIs can be cured with antibiotic therapy - page 36
    - The focus for viral STIs is on the development of preventative vaccination, as current therapies fail to eradicate the underlying infection - page 38
    - The benefits of preventative vaccination are best reflected by the dramatic effect of hepatitis B vaccination in reducing the hepatitis B incidence - page 39
    - Resistance to therapy currently affects mainly gonorrhea - page 40
    - The STI pipeline is scarce, mainly due to low unmet needs - page 41
CHAPTER 3 CHLAMYDIA - page 45
- Disease overview - page 45
  - Etiology and epidemiology - page 45
    - Chlamydia causes various diseases, the most common being the STI caused by Chlamydia trachomatis - page 45
    - Chlamydia is the most common STI worldwide - page 45
  - Disease progression and clinical manifestations - page 47
    - In women, chlamydia is the most common reason for infertility and ectopic pregnancies - page 47
    - Pelvic inflammatory disease is predominantly caused by chlamydia and gonorrhea - page 49
- Disease management - page 50
  - Chlamydia can be effectively managed with curative antibiotic therapy - page 50
    - Prevention focuses on low-risk sexual behavior - page 50
    - Chlamydia diagnosis remains sub-optimal - page 50
    - Chlamydia can be cured with single-dose azithromycin - page 51
- Future market outlook - page 53
CHAPTER 4 GONORRHEA - page 54
- Disease overview - page 54
  - Etiology and epidemiology - page 54
    - In the West, gonorrhea is commonly caused by genitourinary exposure - page 54
    - The second most common STI affects predominantly men - page 54
  - Disease progression and clinical manifestations - page 58
    - Untreated gonorrhea can lead to a range of complications in adults and to blindness in the newborn child - page 58
- Disease management - page 60
  - Increasing resistance has been changing prescription practices - page 60
    - Prevention focuses on low-risk sexual behavior, although microbicides are currently being evaluated in the clinic - page 60
    - Three types of laboratory tests allow for correct gonorrhea diagnosis - page 60
    - The gold standard of gonorrhea treatment is single-dose antibiotic therapy - page 61
    - Increasing gonococcal resistance, especially to fluoroquinolones, has led to the preferred use of third-generation cephalosporins - page 63
- Future market outlook - page 65
CHAPTER 5 GENITAL HERPES - page 66
- Disease overview - page 66
  - Etiology and epidemiology - page 66
    - Traditionally caused by HSV-2, genital herpes is now increasingly being caused by HSV-1 - page 66
    - HSV is a ubiquitous disease and most commonly affects women - page 67
  - Disease progression and clinical manifestations - page 68
    - Following the primary infection, patients with genital herpes often suffer from recurrent disease episodes - page 68
- Disease management - page 70
  - With curative antiherpes therapy representing an unrealistic goal, HSV R&D focuses on the development of a prophylactic vaccine - page 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 - page 70
    - Sensitive methods allow for effective diagnosis - page 70
    - Antiviral therapy effectively controls, but does not cure, HSV infection - page 71
    - Valtrex (valacyclovir) is the current HSV market leader - page 73
- Future market outlook - page 76
  - 2009: a blockbuster dies, a vaccine is born - page 76
    - Valtrex's and Famvir's patent expiries in the US are expected to lead to loss of value from 2009 onwards - page 76
    - GSK's Simplirix protects HSV-seronegative women from HSV-2 infection - page 77
    - Two therapeutic HSV-2 vaccines have recently entered Phase I clinical trial - page 80
CHAPTER 6 GENITAL WARTS - page 83
- Disease overview - page 83
  - Etiology and epidemiology - page 83
    - HPVs are a large family of viruses associated primarily with benign warts - page 83
    - HPV warts are the most common viral STI - page 85
  - Disease progression and clinical manifestations - page 88
    - Although most HPV infections are benign, infection with high-risk HPV types can lead to the development of cervical cancer - page 88
- Disease management - page 90
  - HPV cannot be cured, but a prophylactic vaccine might soon reduce the incidence of cervical cancer - page 90
    - 2006 is likely to witness the launch of a first-in-class prophylactic HPV vaccine - page 90
    - A combination of methods is used for the diagnosis of genital warts, HPV DNA and cervical cell abnormalities - page 90
    - Treatment is not curative and consists in the destruction of warts - page 91
- Future market outlook - page 92
  - The future lies in prevention through vaccination - page 92
    - Merck and GSK are currently developing preventative HPV vaccines - page 92
    - Gardasil versus Cervarix - page 95
    - Issues associated with STI vaccination - page 96
    - HPV vaccine market potential - page 99
CHAPTER 7 SYPHILIS - page 102
- Disease overview - page 102
  - Etiology and epidemiology - page 102
    - The great imitator - page 102
    - Recent outbreaks have led to an increase in syphilis cases, in particular in men who have sex with men (MSM) - page 102
  - Disease progression and clinical manifestations - page 106
    - Left untreated, late stages of syphilis can progress to cardiovascular and CNS disease - page 106
- Disease management - page 108
  - If detected early, syphilis can be cured - page 108
    - Prevention relies on low-risk sexual behavior - page 108
    - Diagnosis is achieved through serology and microscopy - page 108
    - Penicillin G is the gold-standard cure for syphilis - page 109
APPENDIX A - page 111
- Bibliography - page 111
  - Journals - page 111
  - Epidemiology - page 112
  - Fact sheets - page 112
  - Press releases - page 113
  - Datamonitor reports - page 113
  - Websites - page 114
  - Miscellaneous - page 114
- Report methodology - page 115
- About Datamonitor - page 116
  - About Datamonitor Healthcare - page 116
  - About the Infectious Disease analysis team - page 117
- Disclaimer - page 118

List of Tables
Table 1: Chlamydia, gonorrhea, syphilis, genital warts and genital herpes: key facts - page 11
Table 2: Developmental prophylactic and therapeutic STI vaccines - page 13
Table 3: STIs covered in this report - page 22
Table 4: Number of reported STI cases in the US - page 25
Table 5: Recommended treatment regimes for common bacterial STIs - page 37
Table 6: While genital herpes is managed with suppressive viral therapy, genital warts are removed using physical or chemical methods - page 38
Table 7: Commonly used antibiotics for the management of chlamydia - page 52
Table 8: Recommended treatments for the management of gonorrhea and gonorrhea/chlamydia coinfection - page 62
Table 9: HSV-2 prevalence in the seven major markets - page 67
Table 10: Antiviral therapies recommend for the treatment of first and recurrent episodes of genital herpes - page 71
Table 11: Valtrex has been approved for several different indications in the management of genital herpes - page 75
Table 12: Ongoing Simplirix trials - page 77
Table 13: Two therapeutic candidate HSV-2 vaccines are currently undergoing Phase I clinical trials - page 81
Table 14: Clinical diseases associated with the different HPV genotypes - page 85
Table 15: Genital warts can be removed using a range of physical or chemical methods - page 91
Table 16: Estimated prophylactic HPV vaccine peak sales - page 101
Table 17: Recommended treatments for the management of the various stages of syphilis - page 110

List of Figures
Figure 1: Epidemiological trends in STIs, UK, 2000-04 - page 12
Figure 2: While bacterial and parasitic infections can be cured with antibiotics, the goal of therapy for viral infections is treatment or prevention of symptomatic disease - page 13
Figure 3: Common STIs can be caused by bacteria, viruses and parasites - page 21
Figure 4: Diagnoses and rates of selected STIs seen at GUM clinics, UK, 2000-04 - page 24
Figure 5: In the US, chlamydia is the most abundant and fastest rising bacterial STI - page 25
Figure 6: Various biological mechanisms have been proposed to explain how STIs increase the risk for HIV infection and transmission - page 27
Figure 7: Population subgroups at higher risk of acquiring STIs - page 28
Figure 8: High-risk sexual behavior is the key risk factor for the high rates of STI transmission among young persons and MSM - page 29
Figure 9: More than half of all reported STIs in the UK in 2004 occurred in young persons aged 16-24 years - page 30
Figure 10: Estimated annual incidence of STIs in pregnant women, US - page 31
Figure 11: Acquisition of an STI during pregnancy can have serious consequences for the newborn child - page 32
Figure 12: The incidence of some STIs differs significantly between men and women - page 33
Figure 13: If left untreated, STIs can lead to long-term sequelae - page 34
Figure 14: Only a small proportion of those infected with an STI are diagnosed and treated - page 35
Figure 15: While bacterial and parasitic infections can be cured with antibiotics, the goal of therapy for viral infections is treatment of symptomatic disease - page 36
Figure 16: In the US, the incidence of acute HBV has declined steadily between 1990-2002, in particular in children and adolescents - page 40
Figure 17: Genital warts, gonorrhea and syphilis could benefit from therapeutic improvements - page 42
Figure 18: In 2004, 66% of reported chlamydia cases in the UK occurred in young people aged 16-24 years - page 46
Figure 19: If left untreated, chlamydia can cause serious complications, especially in women - page 48
Figure 20: Pelvic inflammatory disease PID is predominantly caused by untreated chlamydia and gonorrhea - page 49
Figure 21: Between 2000 and 2004, the number or reported chlamydia cases in the UK increased at an average annual rate of 11.1% - page 51
Figure 22: Reported cases of gonorrhea in the UK, 2004 - page 55
Figure 23: In the UK, the number of reported gonorrhea cases has been decreasing since 2002 - page 56
Figure 24: In the US, gonorrhea incidence has been falling since 1988 - page 57
Figure 25: Failure to treat gonorrhea is associated with the development of serious complications - page 59
Figure 26: Gonorrhea can be diagnosed through three types of laboratory techniques - page 61
Figure 27: Gonococcal resistance has led to a frequent review of US treatment guidelines - page 63
Figure 28: In 2001, in Hawaii, gonococcal resistance rates were close to 20% - page 64
Figure 29: In the UK, in 2004 almost two-thirds of reported genital herpes cases occurred in women - page 68
Figure 30: Once infected with HSV, patients often suffer from recurrent episodes of genital herpes - page 70
Figure 31: Goals of antiviral therapy - page 72
Figure 32: Therapy for genital herpes can be either episodic or suppressive - page 73
Figure 33: Since its first launch in 1995, Valtrex has rapidly captured market share in the HSV/VZV antiviral market - page 74
Figure 34: Two key patent expiries are expected to lead to loss of value in the HSV/VZV market from 2009 onwards - page 76
Figure 35: Overview of completed Simplirix trials - page 78
Figure 36: In the UK, the number of reported episodes of genital warts cases has been increasing at an average of 2.8% since 2000 - page 86
Figure 37: Initial visits to physician offices, US, 1990-2004 - page 86
Figure 38: In the UK, in 2004, the number of reported cases of syphilis occurred predominantly in young persons aged 20-24 years - page 87
Figure 39: HPV genotypes most commonly associated with cervical cancer and genital warts - page 89
Figure 40: Factors that influence the choice of the treatment - page 92
Figure 41: Overview of Gardasil Phase III study presented at the Infectious Diseases Society of America (IDSA) annual meeting 2005 - page 94
Figure 42: Comparison of Merck's and GSK's candidate HPV preventative vaccines - page 95
Figure 43: Potential positioning of developmental prophylactic HPV vaccines - page 99
Figure 44: The rising incidence of syphilis in the US is driven by increasing numbers of infections in men - page 103
Figure 45: In the UK, the number of reported syphilis cases has been increasing since 2000 - page 104
Figure 46: In the UK, in 2004, the number of reported cases of syphilis occurred predominantly in men aged 25 and 44 years - page 105
Figure 47: Syphilis disease progression - page 107

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Sexually Transmitted Infections

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