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Antiviral Therapy News

September 21, 2001

Dual Therapy (Two-Drug Combo) May Work for Some HIV Patients

Findings published in the Journal of Antimicrobial Chemotherapy, suggest that patients with viral loads below 10,000 copies per milliliter of blood and at least 300 to 350 CD4+ cells per microliter of blood can be treated effectively with dual NRTI (nucleoside reverse transcriptase inhibitor) therapy. The therapy "seems to ensure a stable virological, immunological and clinical disease evolution after at least 2 years of follow-up," explains the journal article.

This study suggests that one in five HIV-infected patients appear to remain stable on treatment with an older form of antiretroviral therapy and could be spared the toxicity of highly active antiretroviral therapy (HAART). Common side effects of HAART therapy can include liver damage, abnormal body fat deposits and diabetes. The older treatment, known as dual therapy is not recommended by the Department of Health and Human Services and the Henry J. Kaiser Family Foundation's Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents. HAART still remains the current gold standard of treatment for HIV therapy.

The study followed 163 HIV-infected patients for an average of 24 months after they began dual-NRTI treatment. To monitor HIV patients, viral load and CD4 count were monitored. Over the course of the study period, 113 (or 69%) of the patients on dual-NRTI therapy had viral loads that remained below stable levels. Viral loads climbed above stable levels in the remaining 50 patients, but only 32 (19.6%) saw their CD4 cell count fall by more than 20%. None of the patients in the study developed AIDS or died during the study period.

Source: Journal of Antimicrobial Chemotherapy 2001;48:299-302.

New Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Post-Exposure Prophylaxis

The U.S. Public Health Service (PHS) has published previous guidelines for the management of HIV exposures that included considerations for post exposure prophylaxis (PEP). The last version was dated in 1998. Since publication of the 1998 HIV exposure guidelines, several new antiretroviral agents have been approved by the Food and Drug Administration (FDA) and more information is available about the use and safety of HIV PEP. In addition, questions still exist regarding considerations about PEP regimens (when the source person's virus is known or suspected to be resistant to one or more of the antiretroviral agents that might be used for PEP).

This revised report updates and consolidates all previous U.S. Public Health Service recommendations for the management of health-care personnel who have occupational exposure to blood and other body fluids that might contain hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV). New recommendations for HIV PEP include a basic 4-week regimen of two drugs (zidovudine [ZDV] and lamivudine [3TC]; 3TC and stavudine [d4T]; or didanosine [ddI] and d4T) for most HIV exposures and an expanded regimen that includes the addition of a third drug for HIV exposures that pose an increased risk for transmission. When the source person's virus is known or suspected to be resistant to one or more of the drugs considered for the PEP regimen, the selection of drugs to which the source person's virus is unlikely to be resistant is recommended.

In addition, this report outlines several special circumstances (e.g., delayed exposure report, unknown source person, pregnancy in the exposed person, resistance of the source virus to antiretroviral agents, or toxicity of the PEP regimen) when consultation with local experts and/or the National Clinicians' Post-Exposure Prophylaxis Hotline ([PEPline] 1-888-448-4911) is advised. The report still indicates that occupational exposures should be considered urgent medical concerns to ensure timely post exposure management and administration of HBIG, hepatitis B vaccine, and/or HIV PEP.

There has been public concern also has arisen about the use of PEP when it is not warranted. Data in the new revisions may indicate that some health-care personnel take a full course of HIV PEP after exposures that do not confer an HIV transmission risk. The new guidelines for PEP were published in MMWR (Morbidity and Mortality Weekly Report) in the June 29, 2001/volume 50/No. RR-11 issue. If you have any questions in regards to the new guidelines, you may call the STEP Talkline at 1-877-597-STEP or see the new guidelines at:

The appendices of the report include:

The Food and Drug Administration (FDA) Announces Two Important Meetings of Interest in HIV

On October 3-4, 2001, the federal Food and Drug Administration (FDA) Advisory Committee will have a public meeting located in Silver Springs, Maryland. On October 3, 2001, the committee will discuss new drug application (NDA) 21-356, for Viread, otherwise known as tenofovir disoproxil fumarate (300mg) tablets, proposed for the treatment of human immunodeficiency virus (HIV) infection, sponsored by Gilead Sciences, Inc. Viread is currently available to patients through the Expanded Access Program. For more information on Viread, call the STEP Talkline at 1-877-597-STEP or contact Gilead Sciences website at:

On October 4, 2001, the FDA Advisory committee will discuss another new drug applications (NDA) 21-266, for Vfend (voriconazole) tablets, and (NDA) 21-267, Vfend I.V. (voriconazole) for Infusion, sponsored by Pfizer Global Research and Development, and proposed for the treatment of invasive aspergillosis, serious candida infections, infections caused by scedosporium spp. and fusarium spp., and rare and refractory infections. For more information on either Vfend for Infusion or Vfend, contact the STEP Talkline at 1-877-597-STEP or the Pfizer Global Research and Development website at:

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