Short Communication: Efficacy and Safety of Treatment Simplification to Lopinavir/Ritonavir or Darunavir/Ritonavir Monotherapy: A Randomized Clinical Trial.

Antiretroviral treatment simplification strategies based on monotherapy with darunavir/ritonavir (DRV/r) or lopinavir/ritonavir (LPV/r) have not been directly compared in clinical trials. We evaluated the 48-week efficacy and safety of DRV/r versus LPV/r monotherapy as a treatment simplification strategy in a multicenter, randomized open-label study. Maintenance of viral suppression in cerebrospinal fluid (CSF) and semen was also explored. An intention to treat efficacy analysis was performed considering missing equals to failure (ITT:M = F). Virological failure (VF) was defined as a confirmed increase in plasma HIV-1 RNA >50 copies/mL. A total of 75 patients were enrolled: 40 were allocated to DRVr and 33 to LPVr. In the ITT: M = F analysis, 77.5% of patients on DRV/r and 66.6% of patients on LPV/r maintained HIV-1 RNA <50 copies/mL at week 48 (p = .302, treatment difference 10.8% [95% CI,-12.6 to 34.2]). In the DRV/r arm, no patients developed VF and 15.0% discontinued treatment due to adverse events. In the LPV/r arm, 2 (6.1%) patients developed VF and 18.2% discontinued monotherapy due to adverse events. Gastrointestinal disturbances were experienced by 18.2% and 2.5% of patients in the LPV/r and DRV/r arms, respectively (p = .019). Two patients had detectable HIV-1 RNA ≥50 copies/mL in CSF or semen. Monotherapy with LPV/r or DRV/r seems to be virologically effective in selected HIV-1-infected patients with sustained viral suppression. Differences between both regimens seem driven mainly by the better tolerability profile of DRV/r.

Distribution of human papillomavirus genotypes in anal cytological and histological specimens from HIV-infected men who have sex with men and men who have sex with women.

BACKGROUND: Anal cancer is caused by human papillomavirus (HPV). Moreover, human immunodeficiency virus (HIV) is an additional risk factor for anal cancer. Therefore, when designing preventive protocols for HIV-infected men, it is important to detect high-risk (HR) oncogenic HPV genotypes present in their anal canals. However, most studies have focused only on men who have sex with men (MSM). OBJECTIVE: To estimate the prevalence of HPV and describe its genotype distribution using anal cytology and histology specimens from HIV-infected populations of MSM and men who have sex with women (MSW). DESIGN: Crosssectional study of the CARH·MEN cohort. SETTING: Single-center prospective cohort of HIV-infected men attending the Outpatient HIV Clinic of Hospital Germans Trias i Pujol (Spain), where they undergo annual screening for HPV infection of the anus, penis and mouth. PATIENTS: Four hundred eighty-three HIV-infected men (341 MSM, 142 MSW) with no current or previous history of anal condylomata. MAIN OUTCOME MEASURES: HPV genotypes detected (multiplex-PCR), cytology results (Papanicolaou test) and histology results (biopsy-based). RESULTS: Cytological abnormalities were detected in 40% of MSM (129/321; 95%CI, 35-46) and 20% of MSW (26/131; 95%CI, 13-28) (OR=2.7; 95%CI, 1.7-4.4). All high-grade squamous intraepithelial lesions (HSIL) were positive for HR-HPV in both groups. High-resolution anoscopy was performed in 146 patients (120 MSM, 26 MSW) with abnormal cytological diagnoses. Lesions were visualized in 80 MSM (67%) and 14 MSW (54%) (OR=1.7 [95%CI, 0.7-4.0]). Histological diagnosis was anal intraepithelial neoplasia (AIN)-1 in 51 MSM (64%) and 6 MSW (43%), AIN-2 in 9 MSM (11%) and 3 MSW (21%), AIN-3 in 7 MSM (9%) and 1 MSW (7%), and normal in 13 MSM (16%) and 4 MSW (29%). HPV16 was the most prevalent HR genotype. LIMITATIONS: Study limitations include its crosssectional design. CONCLUSIONS: Anal cancer screening should be offered to all HIV-infected men, regardless of their sexual orientation.

Prevalence, clearance, and incidence of human papillomavirus type-specific infection at the anal and penile site of HIV-infected men.

BACKGROUND: We studied the type-specific infection of human papillomavirus (HPV) at the anal canal and penile site in a cohort of HIV-infected men. METHODS: Prevalence, clearance, and incidence of specific HPV types in the anal canal and penis were determined in 733 HIV-infected men from the Spanish CAn Ruti HIV+ Men ([CARH•MEN]) cohort (538 men who have sex with men [MSM] and 195 heterosexual men). RESULTS: In both groups, the most prevalent high-risk type was HPV-16 (anal canal [31.6% MSM; 6.8% heterosexual] and penis [4.8% MSM; 6.8% heterosexual]). The most prevalent low-risk type was HPV-6 (anal canal [23.2% MSM; 12.8% heterosexual], penis [8.1% MSM; 8.9% heterosexual]). Anal prevalence was significantly higher in MSM, as was incidence, except for HPV-16, which was similar between male groups (5.9 new cases per 1000 person-months [95% confidence interval, 4.3-7.9] in MSM; 4.4 [95% confidence interval, 2.5-7.2] in heterosexual men; P > 0.05). The anal clearance rate of the different HPV types and retention time of infection were similar in both groups, as well as the HPV infection of the penis. CONCLUSIONS: HIV-infected MSM had a high prevalence of HPV infection at the anal canal; however, heterosexual HIV-infected men were also at risk for acquiring and sustaining persistent high-risk HPV types at the anal and penile site and are at risk for developing dysplasia in the future. All HIV-infected men should be recommended for routinely anal HPV screening.

Natural history of human papillomavirus infections involving anal, penile, and oral sites among HIV-positive men.

AIM: The aim of this study was to characterize the natural history of human papillomavirus (HPV) infection at anal canal, penile, and oral sites in HIV-positive men based on their sexual behavior. METHODS: This is a single-center, prospective cohort study. The prevalence, clearance, and incidence of HPV infection at anal, penile, and oral sites were studied in HIV-positive men who have sex with men (MSM) and heterosexual individuals using multiplex polymerase chain reaction. Risk factors associated with HPV infection were analyzed. RESULTS: In total, 733 patients (538 MSM, 195 heterosexual) were included in the study between 2005 and 2009. The prevalence, clearance, and incidence of HPV infection were 73%, 30%, and 36% at anal site; 26%, 56%, and 17% at penile site; and 16%, 44%, and 11% at oral site, respectively. At anal site, MSM had a higher HPV prevalence (84% vs. 42%; odds ratio,7.3; 95% confidence interval [CI], 5.2-10.6) mainly for multiple (≥3) HPV types, higher incidence rate (324 vs. 92 new HPV-infected person per 1000 person-years [hazard ratio, 8.1; 95% CI, 3.8-17.3]), and a lower clearance rate (125 vs. 184 cleared HPV-infected person per 1000 person-years [hazard ratio, 0.5; 95% CI, 0.3-0.9]) than did heterosexuals. Similar prevalence, clearance, and incidence rates of penile and oral HPV infection were found between groups. The most common high-risk HPV type for the 3 body sites studied was the HPV-16. Finally, a similar proportion of heterosexuals (7%) and MSM (6%) presented concurrent HPV infections (anal-penile-oral sites). History of anal warts was associated with higher HPV prevalence in the 3 body parts. CONCLUSIONS: Although MSM presented the highest risk of anal HPV infection, heterosexual men also showed a remarkable prevalence of anal HPV infection and a comparable risk to MSM for penile and oral HPV infection. Taking into account all these results, the careful inspection of the anal canal, penile, and oral sites should at least be routine in each clinic visit of HIV-infected men independently of their sexual behavior.