Cameroon study shows hepatitis C treatment is feasible, highly effective in sub-Saharan Africa

High cure rates for hepatitis C can be achieved in Cameroon but the cost of treatment remains out of reach for all but the wealthiest, findings from a demonstration study of direct-acting antiviral therapy published in Tropical Medicine & International Health show.

Over 10 million people were estimated to be living with hepatitis C in sub-Saharan Africa in 2015. Direct-acting antiviral treatment for hepatitis C remains out of reach in most African countries due to a lack of national screening and treatment programmes, lack of funding for treatment and unaffordable treatment.

Although tiered pricing and voluntary licensing agreements for lower-income and lower-middle-income countries have cut prices of direct-acting antivirals, the lack of national funding means that treatment must be funded by individuals. Cameroon negotiated a price of $1203 for a 12-week course of sofosbuvir/ledipasvir in 2016.

Pharmacess Foundation, University of Amsterdam and University of Yaoundé carried out the HepC-IMPACT pilot study in Cameroon to investigate the feasibility of delivering direct-acting antiviral treatment in clinics in Yaoundé, the capital city of Cameroon.

The study recruited 161 people with chronic hepatitis C diagnosed either due to liver-related symptoms or after screening of a blood donation. The study excluded people with decompensated cirrhosis or hepatocellular carcinoma, kidney disease and people with chronic hepatitis B infection. People living with HIV were eligible to join the study if they had an undetectable viral load on antiretroviral therapy, CD4 cell count above 350 and no opportunistic infections.

Study participants had a median age of 61 years, 65% were women, 6% were HIV positive, 50% had genotype 4 infection, 35% genotype 1 infection and the remainder, genotype 2. Half had F0-F2 fibrosis, 18% F3 fibrosis and 31% F4 fibrosis (cirrhosis).

The most common risk factors for hepatitis C acquisition were a history of exposure to collective vaccination (75%), scarring or tattoos (60%), invasive surgery (43%) or traditional medical treatments with sharp objects (36%).

A total of 161 people began treatment with either sofosbuvir/ledipasvir (12 weeks) (94); sofosbuvir/ledipasvir/ribavirin (12 weeks) (39); sofosbuvir/ribavirin (21); sofosbuvir/ledipasvir (24 weeks) (6); or sofosbuvir/ledipasvir/ribavirin (16 weeks) (1).

One hundred and fifty eight people completed treatment and 152 (96%) achieved a sustained virological response, including eleven patients who experienced interruptions to treatment. Seventy-five per cent of study participants reported good adherence throughout their treatment course but there was no significant difference in virological outcomes according to level of adherence.

The most common adverse events were asthenia (12.0%), headache (11.4%) and dizziness (18.9%). Three people died during treatment of co-morbidities not associated with treatment. Study participants had a high burden of co-morbidities (42% had hypertension and 18% had diabetes).

Five of the six people who did not achieve a sustained virological response had hepatitis C NS5A and NS5B mutations associated with resistance to ledipasvir and sofosbuvir but the investigators say it is unclear if these mutations contributed to treatment failure or if they were naturally occurring mutations circulating in genotype 1 sub-types in Cameroon.

The total costs of treatment including laboratory tests was 1914 euros. The average drug cost was 477 euros. Participants in this study paid 25% of the drug costs. The investigators say that the cost of treatment would have been reduced by 293 euros if they had used a pan-genotypic direct-acting antiviral combination to avoid genotyping and used blood tests alone to determine fibrosis.

The study investigators say that as well as reductions in treatment costs, decentralisation of treatment from specialist clinics will be necessary, as part of a national hepatitis strategy that rolls out hepatitis screening and treatment to non-specialist health facilities.