001), abdominal pain (P = 0.02), stomach pain (P = 0.049) and dizziness (P = 0.01) than those in the no-treatment group. These differences had disappeared by week 24. Temporary cART during PHI had a significant positive impact on patients’ HRQL as compared with no treatment, despite the initial, short-term occurrence of more physical symptoms, probably related to drug toxicity. The impact of temporary combination antiretroviral therapy (cART) during primary HIV-1 infection (PHI) on the viral set-point and HIV
disease progression has recently been studied in three randomized clinical trials (RCTs), and showed that early cART provided a clinical benefit [1-3]. In the Primo-SHM trial, an open-label RCT comparing no treatment with 24 or 60 weeks of cART PF-02341066 mouse during PHI, we demonstrated that temporary early cART lowered the viral set-point and deferred the need for reinitiation of cART during chronic HIV-1 infection [1]. Both the Short Pulse Anti-Retroviral Therapy at HIV Seroconversion (SPARTAC) trial, which compared no therapy with 12 or 48 weeks
of cART in PHI, and the SETPOINT study, which compared no therapy with 36 weeks of cART, reported that a period of 48 and 36 weeks of cART, respectively, modestly VX-809 in vivo delayed disease progression [2, 3]. However, during the acute stage of HIV-1 disease, patients are often physically and emotionally distressed, and the initiation of cART may have a negative impact on their health-related quality of life (HRQL) as a result of pill burden, the need for strict adherence to cART and potential drug-related adverse events and toxicity [4, 5]. Conversely, early cART may also have a positive effect on patients’ HRQL, by delaying disease progression and lowering the plasma viral load, and because patients may feel they are actively ‘doing something’
about the PHI [6]. In chronic HIV infection the potential negative effects of cART on patients’ HRQL are generally offset by positive effects [7-10]. The aim of the current Primo-SHM substudy was to compare the impact on HRQL of 24 or 60 weeks of cART during PHI versus no treatment, over a study period of 96 weeks. Patients were selected between May 2003 and April 2010 from the Primo-SHM cohort; Primo-SHM is a multicentre prospective Progesterone cohort study in the Netherlands, with an embedded completed RCT, that investigates the natural course of HIV-1 infection, and the effects of 24 and 60 weeks of early cART in PHI patients [1, 11]. For the present substudy, we included patients from both the cohort and the RCT. Main inclusion criteria were age ≥18 years and laboratory evidence of PHI, defined as having a negative or indeterminate western blot in combination with detectable plasma HIV-1 RNA, or, in the case of a positive western blot, a proven negative HIV-screening test result within the previous 180 days.