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IntroductionHIV testing opportunities in Italy are frequently limited to the hospital setting. Experiences in other countries show that offering HIV testing in other facilities could improve HIV testing uptake.MethodsAn internet‐based survey was conducted between March 10 and April 3, 2014.ResultsA total number of 348 questionnaires were collected. Responders were 88% male. Most represented age groups were 25–34 (35%) and 35–44 (25%). Most of the responders identify themselves as homosexual (81%) or bisexual (9%). Half of responders had an HIV test within 2 years (56%) while 18% never tested for HIV. Among all responders, 61% had more than 2 sexual partners in the past year. Reported condom use in the past year was: always 39%, always but once 11%, sometimes 27%, never 14%. Most known places to have an HIV test is the hospital (95%), STI clinic (58%) and chemical analysis laboratory (54%); most used places are hospital (73%), STI clinic (30%), laboratory (22%) while 5 responders reported having had a self‐test at home. Preferred places where to have an HIV test is self‐testing at home (53%), hospital (36%), pharmacy (32%) and headquarter of an organization (31%). Most known testing method is draw blood from vein (97%), which is also most used (80%) but the least preferred (31%) while saliva (65%) and finger prick (56%) are the preferred choices. Most responders know that physicians (84%) and nurses (77%) are those who perform HIV tests and most of them had an HIV test with them (60% and 65% respectively). Physicians are the preferred operators (54%) followed by self‐testing (46%), nurses (46%) and peer‐volunteers (39%). The ideal HIV test should be: reliable (86%), with no medical prescription (75%), free (63%), rapid (55%), with no personal information collected (45%), with the opportunity to speak with a peer‐counsellor (36%).ConclusionsChanging HIV testing policies in Italy is urgently needed in order to grant a better access to the service: waiting for the results and bureaucratic obligations represent the major barriers to be removed. Home‐testing and community‐based testing seem to be among the best ways to offer new opportunities though they may require a change in the legal, social and cultural context to be implemented and home testing will not allow any kind of support for newly diagnosed people.

IntroductionIn the United Kingdom and Ireland more than 40% of individuals living with perinatally acquired HIV are now aged >16. Globally, increasing numbers of women with perinatally acquired HIV are becoming pregnant, but data on fertility and pregnancy outcomes is scarce. We present pregnancy outcome data for this emerging cohort.MethodsPregnancies in diagnosed HIV‐infected women in the United Kingdom and Ireland, and children diagnosed with HIV, are reported to the National Study of HIV in Pregnancy and Childhood. We analyzed data on pregnancies in women diagnosed aged ≤13 with perinatally acquired HIV, reported by June 2014.ResultsA total of 759 females born before 2001, diagnosed with perinatally acquired HIV aged ≤13 years, and in care in the UK and Ireland have been reported. Forty‐four of these (6%) have had at least one pregnancy reported, with nineteen 2nd and four 3rd/4th pregnancies. Women's year of birth ranged from 1985 to 1996; 60% of women were UK/Irish‐born and 39% African‐born. Twenty one percent were diagnosed at <2 years, 39% at 2–7 and 41% at 8–13 years. Nine pregnancies were conceived in 2005–07, 22 in 2008–10 and 36 in 2011–13. Median age at conception of first pregnancy was 19 years. CD4 count was >500 cells/µL in 36% of first pregnancies, 350–499 in 15% and <350 in 49%. Women were on antiretroviral therapy (ART) at conception in 71% of pregnancies. There were 51 singleton live births, 2 miscarriages, 9 terminations and 5 continuing to term. In 17 live births to women not on ART at conception, median gestational age at start of ART was 17 weeks (range 3–29). HIV viral load was <50 copies/mL near delivery in 64% of live births, 51–1000 in 31% and >1000 in 5%. Forty four percent of live births were delivered by elective caesarean section (CS), 27% by emergency CS, 27% by planned vaginal delivery and with one unplanned vaginal delivery. Of 29 live births with viral load <50, 31% were delivered by elective CS, 17% by emergency CS and 52% by vaginal delivery. Fifteen percent of infants were delivered at 32–36 weeks gestation, and 2% at 30 weeks; 16% weighed 1.5–2.5 kg and 16% weighed <1.5 kg. Among 38 of the 51 infants where infection status is already reported, one is perinatally infected.ConclusionsCurrently at least 6% of perinatally infected women in care in the UK and Ireland have experienced one or more pregnancies. Linking paediatric, pregnancy and second generation data will enable further monitoring of pregnancy outcomes in this newly emerging population.

IntroductionBone mineral density (BMD) assessment in HIV patients is sparsely done in resource limited settings.Materials and MethodsWe conducted a cross‐sectional study of BMD amongst HIV patients following up in our clinic from 1 June to 1 December 2013 by performing dual‐energy X‐ray absorptiometry scan (Lunar Prodigy Advanced DXA System, GE Healthcare) of lumbar spine and hip. Patients on long term (≥12 months), virologically suppressive antiretroviral therapy (ART) were included. Patients who were ART naïve were included as control population. Virologic failures were excluded. Low BMD was defined by WHO T‐score criteria (normal: T score ≥−1;osteopenia: T score between −1 and −2.5 SD; osteoporosis: T score ≤−2.5 SD). Baseline risk factors associated with low BMD like age, low BMI, lipoatrophy, diabetes mellitus, current smoking, current alcohol intake, steroid exposure and menopause were recorded. ART‐related factors associated with low BMD like ART duration, exposure to tenofovir and exposure to protease inhibitors (PI) were studied.ResultsA total of 536 patients (66% males, 496 ART experienced and 40 ART naïve) were included in this analysis. Median age was 42 years, mean BMI 23.35 kg/m2 and median CD4 count 146 cells/mm3. All ART experienced patients had plasma viral load<400 copies/ml.Prevalence of low BMD amongst ART naive and ART experienced patients was 67% (osteopenia: 70.4%, osteoporosis: 29.6%) and 80.4% (osteopenia: 63.4%, osteoporosis: 36.6%), respectively (p=0.05). Mean T scores at lumbar spine and hip for ART naive and ART experienced patients were −1.37 and −0.9 versus −1.56 and −1.48 (p=0.05), respectively. Age, low BMI, current smoking, menopause, baseline CD4 count and exposure to ART were factors significantly associated with low overall BMD on univariate regression analysis. On multivariable logistic regression analysis age (p<0.001), low BMI (p<0.001), current smoking (0.05) and menopause (0.03) were associated with low BMD. BMI decrease of 1 kg/m2 and baseline CD4 decline of 50 cells/mm3 lead to 14% and 4% increased probability of low BMD, respectively. Choice of antiretroviral use (tenofovir vs non‐tenofovir, PI vs No PI) did not influence loss of BMD.ConclusionsExtremely high prevalence of accelerated BMD loss amongst ART naïve and ART experienced patients in our cohort is a matter of deep concern due to its association with pathological fractures. Bone mineral loss was seen irrespective of ART used. Association of low BMD with low baseline CD4 count strengthens the case for early ART.

IntroductionRecreational drug consumption has been associated with both higher rates of risk activities related to HIV transmission and also worse adherence and management of HIV patients under HAART treatment. Moreover, relevant interactions may be present in patients under HAART treatment. Our aim is to present the European trends of drug consumption per country and age groups and assess the way drug consumption is addressed in general HIV guidelines.Materials and MethodsLast 12‐month prevalence drug use was obtained from the European Monitoring Centre for Drugs and Drug Addiction for the four most consumed drugs (cannabis, cocaine, amphetamines, ecstasys). Consumption rates were collected and analyzed by country and age. Principal HIV guidelines were assessed to identify the degree of incorporation of drug use issues at three levels: transmission risk, adherence to the HAART and management of interactions. Guidelines: (a) WHO; (b) EACS; (c) BHIVA; (d) US DHHS; (e) IAS‐USA; (f) GESIDA; (g) French CPG; (h) Italian CPG.ResultsData on drugs of abuse consumption was obtained from 29 European countries, with results showing relevant drug utilization in Europe. Cannabis was the most frequent drug across all countries, with 10 countries over 5% of prevalence over the last year. Other drugs prevalence accounted for about 0.5–1%, reaching up to: 2.1% for cocaine in Spain, 1.4% for ecstasy in the Netherlands and 1.1% for amphetamines in Estonia. 15–24 and 25–34 years old subgroups had the highest prevalence, although notable use of cannabis and cocaine was also found in the 35–44 and 45–54 subgroups. From the eight guidelines assessed, six considered recreational drugs at any point. Recommendations for specific drugs were given in 50% of the guidelines. From those guidelines addressing drug consumption: three assessed risk habits which related to transmission risk, six appraised issues on adherence to HAART and five comprised data on interactions between recreational drugs and HAART. Additionally, five guidelines mentioned drugs in the context of other issues, such as sexual dysfunction or HIV‐associated neurocognitive impairment.ConclusionsUse of recreational drugs is frequent in Europe, not only in the younger population but also in other unexpected older subgroups. The scarce information found in the guidelines has a potential implication for patients and clinicians; therefore, there is a need to include specific recommendations about the clinical management of people living with HIV who use recreational drugs.

Given the challenge of delivering complex, expensive and potentially harmful antiretroviral therapy (ART) on a global level, there is intense interest in the development of short‐term, well‐tolerated regimens that allow individuals to interrupt therapy indefinitely without experiencing a rebound in viremia. This so‐called "cure" or "remission" might be due to complete eradication of all replication‐competent HIV during ART or durable host‐mediated control of persistent virus in absence of ART. Recent heroic interventions such as hematopoietic stem cell transplant and very early initiation of antiretroviral therapy suggest that dramatic reductions in the reservoir size can be achieved, but that complete eradication will be difficult if not impossible to achieve. Most attempts to stimulate effective host‐mediated control of HIV have failed. It is likely that for a true cure to be achieved, both approaches – reductions in the reservoir size and durable immune surveillance – will be needed, a state that is similar to that observed in "elite" controllers and post‐treatment controllers. The implications for recent advances and setbacks in achieving HIV remission for future research priorities will be discussed.

ART coverage among HIV‐positive population varies, depending on the countries, between 10% (e.g. Indonesia) and 65% (Botswana). Death rates and new HIV infections have been linked to ART coverage. Therefore, streamlining tasks and roles to expand treatment and care and to provide quality and equitable health is an ongoing concern globally. One concept that has been applied to improve the delivery of HIV services is that of task shifting. Defined as the systematic delegation of tasks from doctors to cadre with less training such as nurses or lay workers, task shifting has been used as an effective strategy to address the current healthcare worker shortage in many African countries. A body of literature supports the use of task shifting as a successful approach in delivering healthcare services including HIV testing, counselling and ART treatment. In addition, in a time of economic burden and scare resources, task shifting may also help to relieve the situation. This concern is highlighted in recommendation of WHO to strengthen and expand human capacity among healthcare workers. The major issues that are raised are: How can task shifting be implemented in a way that is sustainable? How can clinical care services be organized to maximize the potential of the task‐shifting approach while ensuring safety, efficiency and effectiveness? What preconditions must be met, what are the country‐specific factors that will guide decision‐making in the implementation of task shifting? In addition, task shifting should be implemented alongside other efforts to increase the numbers of skilled health workers. Quality assurances mechanisms should provide the necessary checks balances to protect both service users and health workers.

IntroductionAcute hepatitis C virus (HCV) infection has emerged as a major cause of morbidity in the HIV‐infected population. Most guidelines recommend early treatment with pegylated interferon and ribavirin due to higher cure rates. The impact of acute HCV and its treatment on the outcome of the HIV‐infected population is unknown. With new treatment options for HCV, early treatment of acute HCV has to be questioned. Here, we report a long‐term analysis on patients with acute HCV.MethodsRetrospective analysis from an outpatient clinic from Berlin. All patients with the diagnosis of acute HCV according to The European AIDS Treatment Network (NEAT) criteria were included in the database at their date of HCV diagnosis and followed‐up until the last medical contact. Demographic data was taken from the medical file. A fibrosis estimation was performed using transient elastography (Fibroscan(®). A Fibroscan value above 7 kPa was considered as significant fibrosis, above 12.4 kPa as liver cirrhosis. The following outcomes were documented: (a) liver‐related: hepatic decompensation, cirrhosis, hepatocellular carcinoma. (b) non‐liver‐related: death, myocardial infarction, AIDS‐defining event, psychiatric hospitalisation.ResultsA total of 207 cases of acute HCV infection in HIV‐infected patients were diagnosed between May 2002 and September 2013. All patients were male and declared homosexual contacts as their risk factor for having acquired HIV. The mean age was 39 years, 162 patients (78%) were on antiretroviral treatment, and the median CD4 cell count was 593/mm3 (IQR 443–749). At HCV diagnosis, the highest median alanine aminotransferase (ALT) level was 408 IU/mL (159–871), the HCV viral load was 800,000 IU/mL (45x103–2.8x106). 22 cases (11%) cleared their infection spontaneously, 161 (77%) underwent interferon‐based treatment. Of those treated, 58% had a sustained virological response. 36 cases of HCV reinfection were documented. All patients were followed‐up over an interval of 806 patient‐years. The median liver stiffness was 5.3 kPa (4–7) after a median interval of 34 months. 33 patients developed significant fibrosis, and 11 patients (6%) developed cirrhosis. Nine (5%) patients died during follow‐up, and 11 developed non‐liver‐related endpoints. All but one deceased patients had interferon‐based treatment.ConclusionsSevere hepatic disease and death rarely occurs in a highly treated HCV population. As interferon‐based treatment may induce side effects, it is from now on justified to await new HCV treatment options.

IntroductionFor some patients, it remains a challenge to achieve complete virological suppression which is the goal of antiretroviral therapy (ART). Identifying factors associated with low‐level viraemia (LLV) and virological failure (VF) under ART might help to optimize management of these patients.Materials and MethodsWe investigated patients from the Austrian HIV Cohort Study receiving unmodified ART for >6 months with two nucleoside reverse‐transcriptase inhibitors (NRTIs) with either a non‐nucleoside reverse‐transcriptase inhibitor (NNRTI) or a boosted protease inhibitor (PI) or an integrase inhibitor (INSTI) between 1 July 2012 and 1 July 2013 with at least one viral load (VL) measurement below the limit of detection (BLD) or below level of quantification (BLQ) in their treatment history. VF was defined as HIV‐RNA levels ≥200 copies/mL and all other quantifiable measurements were classified as LLV. Factors associated with LLV and VF compared to BLD and BLQ were identified by using logistic regression models.ResultsOf the 2,276 patients analyzed, 1,972 (86.6%) were BLD or BLQ, 222 (9.8%) showed LLV and 82 (3.6%) had VF. A higher risk for LLV and VF was found in patients with ART interruptions and in patients with boosted PI therapy. The risk for LLV and VF was lower in patients from a centre which uses Abbott RealTime HIV‐1 assay compared to the other centres measuring VL by the Roche Cobas AmpliPrep/Cobas TaqMan 2.0. A higher risk for LLV but not for VF was found in patients with a higher VL before ART and shorter ART duration. A higher risk for VF but not for LLV was found in patients of younger age, originating from a high prevalence country, with a lower CD4 count and in male injecting drug users.ConclusionsThis study of well‐defined patients on stable ART over a period of more than six months gives insights into the different factors associated with LLV and VF. In patients with VF, factors associated with adherence play a prominent role, whereas in patients with LLV, the biology of viral replication comes additionally into effect. Despite its observational design, it has implications for patient management and forms the basis for future outcome studies.

IntroductionThe government of Lesotho introduced tenofovir disoproxil fumarate (TDF) for first‐line antiretroviral treatment (ART), as recommended by the World Health Organization (1), in 2008. The use of TDF has been associated with renal toxicity (2); furthermore, renal function outcomes following the use of TDF has not been studied at Roma Health Service Area (RHSA) in Lesotho. Lesotho is a small landlocked country surrounded by South Africa. The study used an analytical design to compare retrospective creatinine clearance (CrCl) data of 312 (64%) antiretroviral treatment naïve adults exposed to TDF and 173 (36%) unexposed patients.MethodsImpaired renal function was defined as CrCl less than 50 mL/min calculated using the Cockcroft‐Gault equation. The Ministry of Health and Social Welfare of Lesotho approved the study on 13 January 2012. The study included adult (excluding pregnant females) HIV patients enrolled on ART between December 2006 and December 2012 at St Joseph's Mission Hospital and at Nazareth Health Centre (RHSA). Patients at Nazareth Health Centre and at St Joseph's Mission Hospital made up 80% of the circa 4 116 HIV patients on ART. Only 485 patients met the set inclusion criteria.ResultsIn 56 patients (17.9%), TDF was found to be contraindicated. The use of TDF was marginally significant factor for renal toxicity (p=0.054) in univariate analysis, but was insignificant (p=0.122) in multivariate logistic analysis. Univariate (p<0.1) and multivariate logistic regression (p<0.05) were performed using STATA® 11. Female gender (p=0.016), hypertension (p=0.009), and age>60 (p=0.004) were significantly associated with CrCl<50 mL/min outcome.ConclusionsIn this study, TDF proofed to be a weak contributing factor of renal impairment. Routine baseline renal function screening should however be adopted to prevent patients with impaired renal function receiving TDF.

IntroductionA dried blood spot (DBS) on filter paper has been used for different tests globally and has gained popularities in resource limited settings especially during HIV/AIDS epidemic. We assessed the efficiency of molecular characterization of HIV‐1 subtypes using DBS collected under field conditions in northern Tanzania.Materials and MethodsIn 2011 and 2012, 60 DBS samples were collected under field conditions from exposed and newly diagnosed HIV‐1 infected children from Kilimanjaro (n=20), Arusha (n=20), Tanga (n=10) and Manyara (n=10).Results and discussionOf 60 DBS analyzed at both Protease (PR) and Reverse Transcriptase (RT) regions, 45 (75%) were analyzed, including 17 (85%) from Kilimanjaro, 15 (75%) from Arusha, 8 (80%) from Tanga, and 5 (50%) from Manyara region. All 45 DBS characterized had viral load above 1000 copies/mL with mean log10 viral loads of 3.87 copies/mL (SD 0.995). The phylogenetic results indicated presence of subtype and circulating recombinant form (CRF). In which, 24 were subtype A1 (53.33%), 16 were subtype C (35.55%), 3 were subtype D (6.67%) and 2 were CRF10_CD (4.35%). All major mutations were detected in the RT region, none from protease (PR) region. The mutations detected were Y181C (n=8), K103 (n=4) and G190A (n=1), conferring resistance to non‐nucleoside reverse transcriptase inhibitors (NNRTIs), and M184V (n=1), conferring resistance to lamivudine and emtricitabine.ConclusionsOur results indicate that DBS collected from field conditions in resource scarcity areas can be used to determine the phylogeny of the virus and drug resistance mutations in areas with diverse HIV‐1 group M subtypes.

BackgroundWe assessed the virological response of DRV/r‐based dual therapy in drug‐experienced patients included in the Italian antiretroviral resistance database (ARCA).Materials and MethodsPatients included in the study were treated with DRV/r in association with raltegravir (RAL), etravirine (ETV) or maraviroc (MAR) following treatment failure(s) and with a resistance test and at least one follow‐up visit available. Observation was censored at last visit under dual therapy and survival analysis and proportional hazard models were used, taking virological failure (confirmed >50 c/mL HIV‐RNA) as the end‐point.ResultsOf the total 221 patients included, 149 (67.4%) started DRV/r with RAL, 45 (20.4%) with ETV, 27 (12.2%) with MAR. Patients characteristics at the start of dual regimen were as follows: mean number of previous regimens, nine (IQR: 5–13); non‐B subtype, 17 (7.7%); median CD4 count, 347 (IQR: 246–544); undetectable viral load, 74 (33.5%). Full DRV/r resistance was detected in one (0.5%, HIV‐DB interpretation system), 13 (5.9%, ANRS) and 17 patients (7.7%, Rega). 69 virological failures (31.2%) were observed during follow‐up. At survival analysis, the overall proportion of failure was 29.2% at one year and 33.8% at two years. The proportion of failure was lower in patients starting with undetectable versus detectable viral load (13.3% and 25.2% versus 37.4% and 38.8% at one and two years, respectively, p=0.001 for both analyses) and in patients treated with DRV 600 BID versus 800 QD (HR: 0, 56; 95% CI 0.31–0.99; p<0.05). By regimen, patients treated with DRV/r‐RAL showed a non‐significant lower proportion of failure (27.7% at one year, 32.0% at two years) if compared with DRV/r‐MAR (35.9%, 47.1%) and DRV/r‐ETV (34.1%, 34.1% at one and two years). In the adjusted proportional model, no significant difference among the three regimens was detected. A significant lower risk of failure was associated with higher overall GSS (HIV‐DB HR: 0.53, 95% CI 0.32–0.88, p=0.014; Rega 0.60, 0.40‐0.88, p<0.01; ANRS 0.55, 0.34–0.90, p=0.017), while a higher risk of failure was associated with detectable HIV‐RNA (3.02, 1.70–5.72, p<0.001).ConclusionsAmong experienced patients, the best candidates to dual‐therapy regimens including DRV/r are those with undetectable viral load and higher GSS. The association with RAL is the most commonly used but no clear advantage with respect to ETV or MAR was observed in our dataset, possibly due to the limited sample size.

IntroductionCobicistat, a component of stribild (STB), is known to inhibit renal creatinine secretion. A detailed analysis of the renal safety profile of STB in two Phase 3b switch studies of virologically‐suppressed individuals on stable therapy: STRATEGY(S)‐PI (STB vs a RTV‐boosted protease inhibitor [PI] with emtricitabine and tenofovir DF [FTC/TDF]); and STRATEGY(S)‐NNRTI (STB versus a non‐nucleoside reverse transcriptase inhibitor [NNRTI] with FTC/TDF) is herein described.Materials and MethodsBaseline eGFR ≥70 mL/min was an inclusion criterion. The renal safety profile of STB was examined by baseline eGFR through week 48 (i.e., changes in eGFR, renal tubular laboratory abnormalities, investigator‐reported renal adverse events leading to discontinuation and unreported subclinical proximal renal tubulopathy [PRT]). Subclinical PRT was defined as a confirmed serum‐creatinine increase ≥0.4 mg/dL and two or three markers of renal tubular dysfunction (hypophosphatemia, normoglycemic glycosuria, proteinuria) occurring at the same visit at least once and with no alternative etiologies.ResultsIn S‐PI, 433 subjects (STB 293; PI 140) and in S‐NNRTI, 434 subjects (STB 291; NNRTI 143) were randomized and treated. Most (>85%) STB subjects had a baseline eGFR ≥90 mL/min. STB subjects with baseline eGFR <90 mL/min had smaller declines in eGFR compared to those with baseline eGFR ≥90 mL/min and similar occurrences of renal tubular laboratory abnormalities (Table 1). Rate of renal adverse events leading to study drug discontinuation were similar for the STB group (one PRT in a subject with baseline tubular laboratory abnormalities consistent with underlying PRT and one isolated increase in serum creatinine) and PI group (one isolated decrease in eGFR); none in the NNRTI group. The case of PRT improved after study drug discontinuation. There were no cases of unreported subclinical PRT in any group.ConclusionsIn this virologically suppressed patient population, the renal safety of STB did not differ by baseline eGFR. The renal discontinuation rate was low in the STB group, similar to the RTV‐boosted PI group, and consistent with published historical rates.

IntroductionIn HIV+ patients exhibiting multidrug resistance (MDR), NRTIs often have little activity, increased toxicity, drug interactions and add unnecessary treatment costs. The 48 week VERITAS study demonstrated that these patients can have a safe and effective simplification of salvage regimen by removing inactive NRTIs as determined by genotypic data. Virological, immunological, clinical and financial outcomes were evaluated at an additional 96 weeks of follow‐up.Materials and MethodsMDR patients with an undetectable viral load (VL) on a stable regimen containing at least four ARVs (including one inactive NRTI) were enrolled in an open‐label, prospective simplification trial, where one inactive NRTI was removed at baseline (BL). A second NRTI could be removed at week 24 if the regimen contained at least five ARVs at enrolment.Results31 male patients participated. The mean length of treatment was 14 years, with a median CD4 count of 525. The BL regimen consisted of 4 ARVs in 22 patients (71%) and 5 ARVs in 9 patients (29%). 3TC or FTC was removed in 29 patients (94%), and either AZT or TDF was interrupted in 2 others. Four patients had a second NRTI stopped. One patient was removed at W26 as an active NRTI was removed for creatinine elevation. 30 well‐controlled patients continued follow‐up after W48. At W144, six patients had additional changes in their ARV regimen. Half were due to toxicity (jaundice, neuropathy and nephrotoxicity) while the other half were the result of treatment simplification. None of the patients exhibited virologic failure at the time of treatment change and maintained undetectable VLs throughout the entire follow‐up. These six patients had a mean gain of 79 CD4 (p=0.17) compared to baseline. 22 of the 24 patients (92%) with no changes in ARV therapy after W48 had undetectable VLs. The other two had confirmed virologic failure, one with genotypic resistance. All 24 had elevated CD4 counts (mean +118 CD4, p<0.0001). No deaths or serious adverse events were observed. One or two ARV removals translated to a mean annual saving of $3319 CDN (11%) and $8630 (24%) respectively.ConclusionsFinal results indicate that removing one or two inactive NRTIs from a regimen in patients taking four or more ARVs with controlled VL appears to be safe, maintains virological suppression through 144 weeks and significantly reduces treatment costs.

IntroductionEpidemiological studies suggest that some antiretroviral drugs may contribute to increase cardiovascular risk in HIV‐infected patients. However, data from Latin American countries are limited, as impact of HAART on cardiovascular risk remains understudied. In this context, we aimed to evaluate if 10‐year Framingham Cardiovascular Risk Score (FCRS) increases in patients following exposure to EFV‐ and LPV/r‐based HAART in a Latin American cohort.Materials and MethodsRetrospective 48‐week cohort study. We reviewed clinical charts of randomly selected samples of patients initiating (according to national guidelines) EFV first‐line HAART and LPV/r first‐ or second‐line (but first PI‐based) HAART assisted at a reference HIV centre in Buenos Aires, Argentina (period 2004–2012). Each patient could only be included in one arm. FCRS was calculated according to National Institutes of Health risk assessment tool (http://cvdrisk.nhlbi.nih.gov/).ResultsA total of 357 patients were included: 249 in EFV arm and 108 in LPV/r arm (80 as first line and 28 as second line, but first PI‐based HAART). Baseline characteristics (median, interquartile range): age, 38 (33–45) years; male, 247 (69%); viral load, 98200 (20550–306000) copies/mL; CD4 T‐cell count, 115 (60–175) cel/µL; total cholesterol, 159 (135–194) mg/dL; HDL: 39 (31–41) mg/dL; LDL: 94 (72–123) mg/dL; current smoker, 29%; on antihypertensive drugs: 14 (4%), diabetic: 4 (1%). Most frequent accompanying nucleoside reverse transcriptase inhibitors (NRTIs) were 3TC (92%) and zidovudine (AZT; 76%). Baseline FCRS was low, moderate and high for 93%, 7% and 0% of patients on EFV arm and 96.7%, 1.7% and 1.7% on LPV/r arm. On EFV arm, an increase in FCRS category (low to moderate or moderate to high) was observed in 1 patient (0.9%) at 24 weeks and 6 (5,6%) at 48 weeks; 5 (4.7%) decreased category. On LPV/r arm no one varied FCRS category at 24 weeks and 2 (3.4%) increased from low to moderate at 48 weeks (no patient decreased FCRS category). Cumulative incidence of overall cardiovascular events was 1.6% on EFV and 1.8% on LPV/r arms respectively. Probability of increasing FCRS category or having a cardiovascular event did not differ between arms at a significance level of 5%.ConclusionsProbability of increasing FCRS category and cardiovascular events was low and similar in patients exposed to EFV versus LPV/r‐based HAART in a Latin American cohort. ClinicalTrials.gov Identifier: NCT01705873.

IntroductionAntiretrovirals are available at low prices in sub‐Saharan Africa, but these prices may not be consistently available for middle‐income countries in other regions with large HIV epidemics. Over 30% of HIV infected people live in countries outside sub‐Saharan Africa. Several key antiretrovirals are still on patent, with generic production restricted. We assessed price variations for key antiretroviral drugs inside versus outside sub‐Saharan Africa.MethodsHIV drug prices used in national programmes (2010–2014) were extracted from the WHO Global Price Reporting Mechanism database for all reporting middle‐income countries as classified by the World Bank. Treatment costs (branded and generic) were compared for countries inside sub‐Saharan Africa versus those outside. Five key second‐line antiretrovirals were analysed: abacavir, atazanavir, darunavir, lopinavir/ritonavir, raltegravir.ResultsPrices of branded antiretrovirals were significantly higher outside sub‐Saharan Africa (p<0.001, adjusted for year of purchase) (see Table 1). For example, the median (interquartile range) price of darunavir from Janssen was $732 (IQR $732‐806) per person‐year in sub‐Saharan Africa versus $4689 (IQR $4075‐5717) in non‐African middle‐income countries, an increase of 541%. However, when supplied by generic companies, most antiretrovirals were similarly priced between countries in sub‐Saharan Africa and other regions.ConclusionsPharmaceutical companies are selling antiretrovirals to non‐African middle‐income countries at prices 74–541% higher than African countries with similar gross national incomes. However, generic companies are selling most of these drugs at similar prices across regions. Mechanisms to ensure fair pricing for patented antiretrovirals across both African and non‐African middle‐income countries need to be improved, to ensure sustainable treatment access.