Pre-Exposure Prophylaxis for HIV Prevention: Concerns about PrEP: Adherence

Via:  http://goo.gl/eKIvSD

Adherence to Antiretroviral Therapy & Its Determinants among Persons Living with HIV/AIDS in Bayelsa State, Nigeria

BACKGROUND:

A high level of adherence is required to achieve the desired outcomes of antiretroviral therapy. There is paucity of information about adherence to combined antiretroviral therapy in Bayelsa State of southern Nigeria.

OBJECTIVES:

The objectives of the study were to determine the level of adherence to combined antiretroviral therapy among the patients, evaluate the improvement in their immune status and identify reasons for sub-optimal adherence to therapy.

METHODS:

The cross-sectional study involved administration of an adapted and pretested questionnaire to 601 consented patients attending the two tertiary health institutions in Bayesla State.

NIGERIA:

The Federal Medical Centre, Yenagoa and the Niger-Delta University Teaching Hospital Okolobiri. The tool was divided into various sections such as socio-demographic data, HIV knowledge and adherence to combined antiretroviral therapy. Information on the patient's CD4+ T cells count was retrieved from their medical records. Adherence was assessed by asking patients to recall their intake of prescribed doses in the last fourteen days and subjects who had 95-100% of the prescribed antiretroviral drugs were considered adherent.

RESULTS:

Three hundred and forty eight (57.9%) of the subjects were females and 253 (42.1%) were males. The majority of them, 557 (92.7%) have good knowledge of HIV and combined anti-retroviral therapy with a score of 70.0% and above. A larger proportion of the respondents, 441 (73.4%), had ≥95% adherence. Some of the most important reasons giving for missing doses include, "simply forgot" 147 (24.5%), and "wanted to avoid the side-effects of drugs" 33(5.5%). There were remarkable improvements in the immune status of the subjects with an increment in the proportion of the subjects with CD4+ T cells count of greater than 350 cells/mm3 from 33 (5.5%) at therapy initiation to 338 (56.3%) at study period (p<0.0001).

CONCLUSION:

The adherence level of 73.4% was low which calls for intervention and improvement. The combined antiretroviral therapy has significantly improved the immune status of the majority of patients which must be sustained. "Simply forgot" was the most important reason for missing doses.

Reasons for sub optimal adherence to combined antiretroviral therapy

Reasons a	Hospital/Sex of respondents N (%)						Total	p-value
	FMC			NDUTH
	Male	Female	Sub-Total	Male	Female	Sub-Total
	Simply forgot	20 (3.3)	62 (10.3)	82 (13.6)	24 (4.0)	40 (6.7)			64 (10.6)	147 24.5)	0.0002
Too many drugs to take	6 (1.0)	1 (0.2)	7 (1.2)	9 (1.5)	5 (0.8)	14 (2.3)	21 (3.5)
Wanted to avoid side-effects	5 (0.8)	12 (2.0)	17 (2.8)	6 (1.0)	5 (0.8)	16 (2.7)	33 (5.5)
Felt Sick	1 (0.2)	4 (0.7)	5 (0.8)	1 (0.2)	5 (0.8)	6 (1.0)	11 (1.8)
Felt depressed/down	2 (0.3)	2 (0.3)	4 (0.7)	2 (0.3)	3 (0.5)	5 (0.8)	9 (1.5)
Felt asleep	3 (0.5)	8 (1.3)	11 (1.8)	2 (0.3)	13 (2.2)	15 (2.5)	26 (4.3)
Drank alcohol	0 (0.0)	1 (0.2)	1 (0.2)	2 (0.3)	6 (1.0)	8 (1.3)	9 (1.5)
Fasting	2 (0.3)	4 (0.7)	6 (1.0)	5 (0.8)	2 (0.3)	7 (1.2)	13 (2.2)
Ran out of drugs	5 (0.8)	13 (2.2)	18 (3.0)	0 (0.0)	2 (0.3)	2 (0.3)	20 (3.3)
Felt better	21 (3.5)	0 (0.0)	21 (3.5)	7 (1.2)	0 (0.0)	7 (1.2)	28 (4.7)
Too busy with other things	17 (2.8)	9 (1.5)	26 (4.3)	7 (1.2)	10 (1.7)	17 (2.8)	43 (7.2)
Fear of others noticing	1 (0.2)	0 (0.0)	1 (0.2)	2 (0.3)	5 (0.8)	7 (1.2)	8 (1.3)
Problems taking drug at specific time	1 (0.2)	0 (0.0)	1 (0.2)	2 (0.3)	5 (0.8)	7 (1.2)	8 (1.3)
Did not want other people to notice	1 (0.2)	8 (1.3)	9 (1.5)	3 (0.5)	9 (1.5)	12 (2.0)	21 (3.5)
Lack of transport fare to get the drug	5 (0.8)	4 (0.7)	9 (1.5)	1 (0.2)	5 (0.8)	6 (1.0)	15 (2.5)
Not applicable	49 (8.2)	53 (8.8)	112 (18.6)	34 (5.7)	53 (8.8)	87 (14.5)	189 (31.4)

aFMC versus NDUTH: chi-square= 41.988, df=15, p<0.0002

Full article at:   http://goo.gl/auQwD4

By:  Suleiman IA1, Momo A2.

• 1Department of Clinical Pharmacy and Pharmacy Practice. Faculty of Pharmacy, Niger Delta University , Wilberforce Island, Bayelsa State ( Nigeria ). suleimanismail1@gmail.com.
• 2Deputy Director, Pharmacy Department, Federal Medical Centre, Yenagoa, Bayelsa State, ( Nigeria ). pharmandymomo@yahoo.com.
• Pharm Pract (Granada). 2016 Jan-Mar;14(1):631. doi: 10.18549/PharmPract.2016.01.631. Epub 2016 Mar 15.

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Factors associated with HIV Viral Load "Blips" & the Relationship Between Self-Reported Adherence & Efavirenz Blood Levels on Blip Occurrence

BACKGROUND:

The uncertain etiology of HIV viral load (VL) blips may lead to increased use of clinical resources. We evaluated the association of self-reported adherence (SRA) and antiretroviral (ART) drug levels on blip occurrence in US Military HIV Natural History Study (NHS) participants who initiated the single-tablet regimen efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF).

METHODS:

ART-naïve NHS participants started on EFV/FTC/TDF between 2006 and 2013 who achieved VL suppression (<50 copies/mL) within 12 months and had available SRA and stored plasma samples were included. Participants with viral blips were compared with those who maintained VL suppression without blips. Untimed EFV plasma levels were evaluated on consecutive blip and non-blip dates by high performance liquid chromatography, with a level ≥1 mcg/mL considered therapeutic. SRA was categorized as ≥85 or <85 %. Descriptive statistics were performed for baseline characteristics and univariate and multivariate Cox proportional hazard models were used to assess the relationship between covariates and blip occurrence.

RESULTS:

A total of 772 individuals met inclusion criteria, including 99 (13 %) blip and 673 (87 %) control participants. African-American was the predominant ethnicity and the mean age was 29 years for both groups. SRA ≥ 85 % was associated with therapeutic EFV levels at both blip and non-blip time points (P = 0.0026); however no association was observed between blips and SRA or EFV levels among cases. On univariate analysis of cases versus controls, blips were associated with higher mean pre-treatment VL (HR 1.45, 95 % CI 1.11-1.89) and pre-treatment CD4 count <350 cells/µL (68.1 vs 49.7 %). Multivariate analysis also showed that blips were associated with a higher mean VL (HR 1.42, 95 % CI 1.08-1.88; P = 0.0123) and lower CD4 count at ART initiation, with CD4 ≥500 cells/µL having a protective effect (HR 0.45, 95 % CI 0.22-0.95; P = 0.0365). No association was observed for demographic characteristics or SRA.

CONCLUSION:

Blips are commonly encountered in the clinical management of HIV-infected patients. Although blip occurrence was not associated with SRA or EFV blood levels in our study, blips were associated with HIV-related factors of pre-ART high VL and low CD4 count. Additional studies are needed to determine the etiology of blips in HIV-infected patients.

Self-reported adherence

Characteristic	All	Blip group	Control group	P value
Total self-reported adherence (%)				0.1603
≥85	597 (96.2)	84 (97.7)	513 (96.1)
<85	23 (3.8)	2 (2.3)	21 (3.9)
Last time missed a dose				0.2097
Last week	100 (16.1)	15 (17.4)	85 (15.9)
Longer than last week	521 (83.9)	71 (82.6)	450 (84.1)
Missed a dose in the last weekend				0.1528
No	572 (93.2)	80 (93.0)	492 (93.2)
Yes	42 (6.8)	6 (7.0)	36 (6.8)
Total missed doses in the last 2 weeks				0.1297
0	489 (78.6)	68 (78.2)	421 (78.7)
1 or more	127 (20.4)	17 (19.5)	110 (20.6)
All doses	5 (0.8)	2 (2.3)	3 (0.6)
Don’t know	1 (0.2)	0 (0.0)	1 (0.2)

Data expressed as N (%) or mean (SD)

Full article at:   http://goo.gl/FuL78U

By:  Farmer A1, Wang X2, Ganesan A3, Deiss RG4, Agan BK2, O'Bryan TA5, Akers K6, Okulicz JF7.

• 1Infectious Disease Service, San Antonio Military Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, TX USA.
• 2Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD USA ; Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, MD USA.
• 3Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD USA ; Walter Reed National Military Medical Center, Bethesda, MD USA ; Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, MD USA.
• 4Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD USA ; Division of Infectious Diseases, Naval Medical Center of San Diego, San Diego, CA USA ; Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, MD USA.
• 5Infectious Disease Service, San Antonio Military Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, TX USA ; Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD USA ; Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, MD USA.
• 6Infectious Disease Service, San Antonio Military Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, TX USA ; United States Army Institute of Surgical Research, Fort Sam Houston, TX USA.
• 7Infectious Disease Service, San Antonio Military Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, TX USA ; Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD USA. 
• AIDS Res Ther. 2016 Mar 22;13:16. doi: 10.1186/s12981-016-0100-4. eCollection 2016.

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Adherence to HIV/AIDS Antiretroviral Therapy among Drug Users: A Qualitative Study in Iran

Background:

The introduction of antiretroviral therapy has caused a remarkable decrease in the occurrence of diseases and mortality among HIV-positive patients, while this success has not been achieved among injection addicts due to a low adherence to antiretroviral medicine. This study aims at clarifying the important factors affecting adherence to treatment in addicts suffering from HIV.

Materials and Methods:

In this qualitative research, data were gathered through in-depth interviews and field notes, and were interpreted through content analysis in the form of constant comparison. The participants were 16 drug addicts living with HIV/AIDS. Most of them had records of imprisonment and were receiving Highly Active Antiretroviral Therapy (HAART) drug treatments in the AIDS center of Imam Khomeini Hospital complex, affiliated to Tehran University of Medical Sciences. Sampling was started in a purposive method and was continued until data were saturated.

Results:

Four main categories including psychological reactions, contradictory beliefs, perceived support, and individual and environmental barriers were extracted from the data, each having some sub-categories.

Conclusions:

The obtained results indicated that adherence to the treatment of HIV is not constant and mono-dimensional, but is a function of different factors. Hence, an individual having feeble adherence in a specific time and under specific circumstances may show desirable adherence under a different circumstance. Thus, treatment of addicts living with HIV/AIDS requires physical, psychological, and social attention along with drug treatments.

Below: The main categories and sub-categories

Full article at:   http://goo.gl/AXn7Ls

By:  Zahra Hosseini,1 Hasan Eftkhar,1 Saharnaz Nedjat,2 Abbas Ebadi,3 Ladan Abbasian,4 Fereshte Zamani,5 Teamur Aghamollaei,6 and Davood Shojaeizade1

¹Department of Health Education and Promotion, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran

²Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran

³Behavioral Sciences Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran

⁴Iranian Research Center of HIV/AIDS, Iranian Institute for Reduction of High-Risk Behaviors, Tehran University of Medical Sciences, Tehran, Iran

⁵Department of Health Education and Promotion, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran

⁶Department of Public Health, Social Determinants on Health Promotion Research center, Health School, Hormozgan University of Medical Sciences, Bandar Abbas, Iran

Address for correspondence: Dr. Hasan Eftkhar, Department of Health Education and Promotion, School of Health, Tehran University of Medical Sciences, Tehran, Iran. 

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PrEP Adherence Patterns Strongly Impact Individual HIV Risk & Observed Efficacy in Randomized Clinical Trials

BACKGROUND:

Randomized controlled trials (RCT) suggest that the efficacy of tenofovir-based pre-exposure prophylaxis (PrEP) strongly depends on consistency of PrEP use. We explore how patterns of pill-taking and waning of PrEP protection may affect PrEP efficacy for HIV prevention.

METHODS:

A two-arm RCT was simulated by mathematical models assuming that prescribed daily doses were skipped periodically, randomly or in large blocks. Risk-driven adherence, in which PrEP was taken when sex was expected, was also investigated. Three temporal PrEP protection profiles were explored: long (5 days), intermediate (3 days) and short (24 hours). Modeling results were compared to the efficacy observed in completed RCTs.

RESULTS:

Expected PrEP efficacy was 60% with periodic, 50% with random and 34% with block adherence when PrEP had a long protection profile and pills were taken only 50% of the days. Risk-driven pill-taking resulted in 29% and 37% daily pills taken and efficacy of 43% and 51% for long protection. High PrEP efficacy comparable with that observed in Partners PrEP and CDC Botswana trials was simulated under long protection, high overall adherence and limited block pill-taking; the moderate efficacy observed in iPrEx and Bangkok trials was comparable with the 50% adherence scenarios under random pill-taking and long protection.

CONCLUSIONS:

Pill-taking patterns may have a substantial impact on the protection provided by PrEP even when the same numbers of pills are taken. When PrEP retains protection for longer than a day, pill-taking patterns can explain a broad range of efficacies observed in PrEP RCTs.

Purchase full article at:   http://goo.gl/ucgzmR

By:  Dimitrov DT1, MÂsse BR, Donnell D.

• 1Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center and Department of Applied Mathematics, University of Washington, Seattle, Washington, USA 
• 2 Sainte-Justine Research Centre, University of Montreal, Montreal, Quebec, Canada 
• 3 Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center and Department of Global Health, University of Washington, Seattle, Washington, USA.
• J Acquir Immune Defic Syndr. 2016 Mar 16. 

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Apparent Antiretroviral Over-Adherence by Pill Count is Associated with HIV Treatment Failure in Adolescents

Pill counts with calculated adherence percentages are used in many settings to monitor adherence, but can be undermined by patients discarding pills to hide non-adherence. 

Pill counts suggesting that >100% of prescribed doses were taken can signal "pill dumping." We defined "over-adherence" (OA) among a cohort of 300 HIV-infected adolescents as having >1/3 of pill counts with >100% adherence during a year of follow-up. Apparent over-adherence was more common in those with virologic failure than those with suppressed viral loads (33% vs 13%, chi p=0.001). 

Pill count adherence repeatedly >100% may identify HIV-infected adolescents at increased risk of treatment failure.

Purchase full article at:   http://goo.gl/SniGCp

By:  Okatch H1, Beiter K, Eby J, Chapman J, Marukutira T, Tshume O, Matshaba M, Anabwani GM, Gross R, Lowenthal E.

• 1Children's Hospital of Philadelphia, Philadelphia, PA, USA 
• 2 University of Pennsylvania Perelman School of Medicine, Masters of Public Health Program, Philadelphia, PA, USA 
• 3 University of Botswana, Gaborone, Botswana 
• 4 Botswana-Baylor Children's Clinical Centre of Excellence, Gaborone, Botswana 
• 5 Baylor College of Medicine, Department of Pediatrics, Section of Retrovirology, Houston, TX, USA 
• 6 University of Pennsylvania Perelman School of Medicine, Departments of Medicine and Epidemiology, Philadelphia, PA, USA 
• 7 University of Pennsylvania Perelman School of Medicine, Departments of Pediatrics and Epidemiology, Philadelphia, PA, USA.
• J Acquir Immune Defic Syndr. 2016 Mar 16 

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