By Liz Highleyman

Standard therapy for chronic hepatitis C virus (HCV) infection consisting of pegylated interferon plus ribavirin is associated with a number of side effects, including depression and blood cell deficiencies.

At the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2008) last week in San Francisco, researchers reported results of a study to assess the frequency and severity of sexual dysfunction as a side effect of interferon-based therapy.

The Study of Viral Resistance to Antiviral Therapy of Chronic Hepatitis C (VIRAHEP-C) was a multicenter study of combination therapy in treatment-naive African-American and Caucasian patients with HCV genotype 1.

A total of 401 participants were enrolled at 8 U.S. centers. All were treated with 80 mcg/week pegylated interferon alfa-2a (Pegasys) plus 1000-1200 mg/day weight-adjusted ribavirin. Patients who remained HCV RNA positive after 24 weeks stopped therapy at that point, while those with undetectable HCV RNA continued treatment through 48 weeks. All were followed for 24 weeks after completion of therapy to determine sustained virological response (SVR).

Self-administered sexual health questionnaires were obtained at weeks 0, 4, 12, 24, 48, and 72. A total of 260 men completed the questionnaire at least once. Five sexual health questions were used to assess sexual desire, function (erection and ejaculation), and satisfaction. Standard SF-36 and CES-D scales were used to assess quality of life and depression.

Results

• At baseline, 37% of the men reported impairment of sexual desire.

• 26% noted erectile dysfunction and 21% reported ejaculatory problems.

• 44% reported moderate or severe dissatisfaction with their sex life.

• During interferon-based therapy, all domains of sexual health worsened:

• Impaired desire to 53%;

• Erectile dysfunction to 39%;

• Ejaculatory dysfunction to 31%;

• Sexual dissatisfaction to 54%.

• By the end of 48 weeks of treatment, 51% of the men reported that their sex life was worse than before therapy.

• Initial impairment as well as worsening of sexual desire, function, and satisfaction were associated with depression.

• 24 weeks after anti-HCV treatment ended, most components of sexual health returned to baseline.

• However, among men treated for the full 48 weeks, the proportion with erectile and ejaculatory dysfunction remained slightly higher than at baseline.

Based on these findings, the authors concluded, "Declines in sexual desire, function and satisfaction are common side effects of combination antiviral therapy in men."

"The onset of dysfunction appears within 4 weeks with gradual worsening over time," they continued. "Most components of sexual dysfunction resolve within 24 weeks of stopping therapy, but erectile and ejaculatory dysfunction may persist in a small proportion."

Finally, they recommended, "Education and counseling regarding the potential of sexual side effects of [pegylated interferon] and ribavirin therapy is warranted."

Internal Medicine, Columbia University College of Physicians and Surgeons, New York, NY; New England Research Institute, Boston, MA; Public Health, University of Pittsburgh, Pittsburgh, PA; National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Health, Bethesda, MD.

11/14/08

Reference
LM Dove, RC Rosen, D Ramcharran, and others. Decline in Sexual Desire, Function and Satisfaction in Men During Peginterferon and Ribavirin Therapy for Chronic Hepatitis C. 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2008). San Francisco. October 31-November 4, 2008. Abstract 267.