Treatment Obligations for Viral STI Microbicide

1
Treatment Obligations for Viral STI Microbicide
Vaccine Trials in Resource-poor Settings

• Kathleen M. MacQueen, PhD, MPH
• Salaam Semaan, DrPH
• 2004 National STD Prevention Conference
• Philadelphia, PA

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Overview

• HPV and HSV-2
• Brief summary
• Microbicide and vaccine clinical trials
• Care options implications
• Could, should, or must?
• Practicable, morally praiseworthy, and obligatory
  options

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HSV-2 summary

• Effective treatment available to prevent HSV-2
  clinical outbreaks
• Reduces likelihood of transmission
• Prevention of new infections in pregnant women
  important for neonatal health
• Could be accomplished by screening treating
  partners
• Prevention of outbreaks shedding important for
  preventing transmission of HIV

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HPV Summary

• Persistent HPV infection is rare, but an
  important contributor to risk for genital cancer
• Current cytologic screening approaches to
  cervical cancer have been successful in reducing
  mortality
• But labor resource intensive generates many
  false positives
• Effective HPV vaccines will help to further
  reduce cervical cancer sequelae

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Microbicide and preventive vaccine trials for
viral STIs

• Primary goal is to assess effectiveness for
  preventing infection
• Disease progression mortality outcomes not
  evaluated for microbicides
• Some vaccine trials may evaluate disease
  progression
• Research participants are healthy but at risk for
  infection disease
• Infections represent important data points
• Risk is subject to modifiable behavior
• Partners infection status is an important
  contributor to risk

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Ethical Challenges for viral STI prevention trials

• Infections are necessary to evaluate microbicide
  and vaccine effectiveness
• Risk of infection may be reduced
• Behavioral interventions with at-risk persons
• Screening treatment of infected partners
• Lower rates of infection require larger and/or
  longer clinical trials
• Infected participants in resource-poor settings
  may not have access to effective treatment and
  care

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The view from HIV prevention trials

• Debate has matured over 5 years
• AIDS treatment activism has increased global
  access to antiretroviral treatment
• ART increasingly practicable in resource poor
  setting
• Assuring access to ART for infected research
  participants is now generally viewed as morally
  praiseworthy
• Some argue it is obligatory
• Some question whether it is practicable
  sustainable

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Implications for viral STI prevention research

• Cost complexity of providing HPV HSV related
  care unlikely to exceed that for ART for HIV/AIDS
• Are HIV prevention research ethics debates
  relevant for STI prevention research?

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Potential care recipients during STI microbicide
vaccine trials

• Infected research participants
• They carry the burdens of the research
• HSV-2 requires lifelong treatment
• HPV infection requires lifelong screening
  access to effective treatment for cervical cancer
• HSV-2 Infected sexual partners
• Treatment reduces likelihood of transmission to
  research participant
• Neonatal risk if pregnant female research
  participants acquire infection
• Treatment of partners can therefore directly
  benefit research participants

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Care options during viral STI microbicide
vaccine trials

• Counseling referral in resource-poor settings
• Adequacy of care
• Cost to research participant
• Transportation
• Stigma
• Limited therapy during trial
• Continuity of care
• Long-term therapy after trial
• Capacity to sustain treatment
• Cost to researcher/sponsor

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Could, should, or must?

• Prevention research ethics is evolving
• Health human rights
• Status quo in resource poor settings should be
  challenged
• Prevention research should contribute to changing
  and not simply exploit an inadequate status quo
• Prevention to care continuum
• Infection is not just a research endpoint but a
  transition point to treatment care
• Lively debates about
• Morally praiseworthy acts
• Moral imperatives or obligations
• Morally dubious claims upon research

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Conclusions

• Prevention researchers can seek to enhance
  justice beneficence in microbicide vaccine
  trials
• Example of convergence of HIV prevention research
  ethics global AIDS treatment activism
• Requires partnership, persistence, and creativity
• Viral STI microbicide vaccine trials are needed
  to address global public health needs
• Ethics debates should enrich, not hinder, this
  goal