Five cases of breast enlargement (gynaecomastia) in HIV-positive individuals taking efavirenz (SustivaTM) -based HAART regimens are reported by Spanish doctors in the May edition of The Breast Journal.
Gynaecomastia is widely (but not universally) recognised as a possible manifestation of the lipodystrophy syndrome in HAART-treated individuals. Several cases of gynaecomastia have been previously reported in individuals taking HAART regimens based on a protease inhibitor. These five case reports from doctors at the Hospital of San Juan in Alicante, Spain implicate an NNRTI in this condition.
An earlier case review conducted at the Chelsea and Westminster Hospital in London, the UK’s largest HIV treatment centre, and presented to the conference of the British HIV Association in 2000, found that the side-effect was associated with the three main classes of anti-HIV drugs, and the London investigators argued that the condition was not a true manifestation of the lipodystrophy syndrome, as it involved glandular disturbance (see link to news story below).
The Spanish investigators conducted an observational longitudinal study of patients diagnosed with gynaecomastia at their centre between late 2000 and late 2001. All cases were confirmed with ultrasound and/or mammography.
A total of five cases were diagnosed, four of which were in men. The patients had a mean age of 37.8 years; three had injecting drug use as their HIV risk factor, the other two patients having haemophilia. Two of the men and the woman were also coinfected with hepatitis C virus. All the patients started an efavirenz-containing HAART regimen between November 2000 and October 2001. Three individuals were naïve to antiretrovirals and all the patients had a CD4 cell count below 200 cells/mm3 when they started HAART.
HAART successfully suppressed HIV viral load below 50 copies/ml in all five patients, and CD4 cell counts ranged between 88 cells/mm3 and 832 cells3 at the time when gynaecomastia was diagnosed.
Gynaecomastia appeared between four and 15 months of commencing HAART. In four patients it involved only one breast, but in one man both breasts were enlarged.
Efavirenz was discontinued in all patients, leading to a regression of gynaecomastia in all cases within a mean of five months.
”We think that HAART-induced gynaecomastia should be suspected in HIV patients receiving efavirenz-containing regimens,” comment the investigators. After reviewing the literature reporting previous cases of the side-effect in protease inhibitor-treated patients, the Spanish investigators conclude that the condition could be caused by immune restoration, or an increase in the female estradiol hormone caused by efavirenz’s interference with the P-450 enzyme.
Further information on this website
Gynaecomastia - overview
Male breast enlargement seen with all drug classes - news story
Jover F et al. Efavirenz-associated gynecomastia: five cases and review of the literature. The Breast Journal 10: 244-46, 2004.