One-day famciclovir vs. placebo in patient-initiated episodic treatment of recurrent genital herpes in immunocompetent Black patients

Abstract

Background:

There are no known racial differences in genital herpes disease pathogenesis or response to therapy. Despite high herpes simplex virus (HSV) seroprevalence in Black persons, clinical trials investigating the treatment of recurrent genital herpes (RGH) have typically enrolled a small proportion of Black patients.

Methods:

This multicenter, double-blind, placebo-controlled study evaluated the efficacy and safety of patient-initiated, 1-day famciclovir 1000 mg twice-daily in immunocompetent Black adults (USA and South Africa) with RGH. Eligible patients were randomized (2:1) to famciclovir or placebo. The primary endpoint was time to healing of non-aborted genital herpes lesions (i.e., lesions that progressed beyond papule stage). Secondary endpoints included proportion of patients with aborted genital herpes lesions, time to resolution of associated symptoms, and safety.

Clinical trial registration:

Trial registration: ClinicalTrials.gov identifier: NCT00477334.

Results:

A total of 299 patients with RGH (66% female, median age = 37 years) received either 1-day famciclovir 1000 mg twice-daily (n = 201) or placebo (n = 98). In the modified intent-to-treat population, the estimated median time to healing of non-aborted genital herpes lesions was 5.38 days for famciclovir and 4.79 days for placebo (median of treatment differences = 0.26 days; 95% CI [−0.40, 0.98]; p = 0.416). Consistent findings were reported in the completer and per-protocol populations. No significant differences were reported for all secondary analyses. Adverse events (AEs) were consistent with the established safety profile of famciclovir: 18 (6%) patients had drug-related AEs (16 [8%] famciclovir; 2 [2%] placebo), none of which were serious or led to discontinuation or dose adjustment/interruption. There are some limitations of this research: many study sites either lacked prior experience in conducting clinical studies in patients with HSV infection or enrolled small numbers of patients, which may have compromised efficacy outcomes. Also, HIV antibody testing was not mandated at enrollment.

Conclusion:

This study showed similar efficacy and tolerability of 1-day treatment with famciclovir 1000 mg twice-daily compared to placebo in immunocompetent Black adults with RGH. Famciclovir has proven efficacy and safety in the overall RGH population. Further understanding of the efficacy of antiherpes therapy in Black patients with recurrent genital herpes may be warranted.

Key words::

• 1-day therapy
• Black
• Famciclovir
• Genital herpes

Transparency

Declaration of funding

Funding for the study and for editorial assistance was provided by Novartis Pharmaceuticals Corporation.

Declaration of financial/other relationships

P.L. has disclosed that he has been a consultant for Johnson and Johnson, Novartis and Genocea, and has received research funding and speaker’s honoraria from Novartis, GlaxoSmithKline, Abbott Diagnostics, and Genocea. M.A. has disclosed that he has received research funding and speaker’s honoraria from Novartis. E.M. and M.G. have disclosed that they have received research funding from Novartis and have no other disclosures. W.Z. and K.H. have disclosed that they are employees of Novartis.

Peer reviewers may receive honoraria from CMRO for their review work. Peer reviewer 1 has disclosed that he/she has been the recipient of research/grant funding from Amgen, Hoffman-La-Roche, Affymax, and Ortho Biotech; is a consultant/advisor to Amgen, Affymax, Ortho Biotech, and Vifor; and is the recipient of honoraria payments from Amgen, Hoffman-La-Roche, Ortho Biotech, and Vifor. Peer reviewer 2 has disclosed that he/she has no relevant financial relationships.

Acknowledgments

Editorial assistance for this manuscript was provided by Teresa Tartaglione, and was funded by Novartis. All statistical analyses were performed by Medpace, Inc., Cincinnati, OH, USA.

Portions of the data presented in this paper were presented at 47th Annual Meeting of the Infectious Diseases Society of America, October 29 – November 1, 2009, Philadelphia, PA, USA (Abstract #LB-25).

Members of the Famvir Study Group

United States: S Blank, Sandy Springs, GA; E Boh, New Orleans, LA; C Breton, Miami, FL; R Cain, Jacksonville, FL; V Challa, High Point, NC; S Chavoustie, North Miami, FL; T Cherpes, Pittsburgh, PA; S Cohen, San Antonio, TX; M Conant, San Francisco, CA; M Abudalu, St. Louis, MO; D Ferris, Augusta, GA; R Hedrick Jr., Las Vegas, NV; R Henry III, Fort Worth, TX; W Jarrett, Hollywood, FL; M Kalafer, Jenkintown, PA; P Leone, Raleigh, NC; T Malloy, Decatur, GA; M Martens, Tulsa, OK; MB Natividad, Arlington, VA; H Oganyan, Huntington Park, CA; L Perez-Limonte, Miami, FL; K Pettis, Charlotte, NC; A Porter, Southfield, MI; H Resnick, Houston, TX; R Saavedra, Las Vegas, NV; R Samaan, Brockton, MA; S Simha, Memphis, TN; T Sligh, Burbank, CA; H Sofen, Los Angeles, CA; R Stewart, Atlanta, GA; A Tydings, Covington, LA; L Weather, Jr., Shreveport, LA; and A Yataco, Towson, MD.

South Africa: K Ahmed, Shoshanguve; AJ Bester, Pretoria; QE Bhorat, Soweto; S Ganesh, Umkomaas; M Gani, Port Elizabeth; R Govinden, Umkomaas; JJ Lombaard, Bloemfontein; C Louw, Ga Rankuwa; E Mitha, Johannesburg; and SR Patel, Durban.